Medical policy and regulation
Medical policy and regulation in healthcare ensure the safety, efficacy and quality of medical treatments and services by setting standards and guidelines for medical practices, drug development and healthcare delivery. Continuous updates and oversight in medical policy and regulation help guide clinical innovation and refine current approaches to healthcare.
Top Stories
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News
16 Aug 2024
Biden administration releases National Heat Strategy
The strategy for 2024–2030 is supposed to promote heat planning, response, and resilience in the wake of extreme heat. Continue Reading
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14 Aug 2024
FDA approves first, only treatment for hypoparathyroidism
Yorvipath, manufactured by Acendis Pharma, was approved as the first and only treatment for hypoparathyroidism on August 12, 2024. Continue Reading
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08 Aug 2024
CDC updates RSV vaccine recommendations for ages 60 and older
The updated recommendations reflect a June 2024 vote from the Advisory Committee on Immunization Practices. Continue Reading
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06 Aug 2024
FDA issues warning on oysters from Lewis Bay
The oysters sold across the US may be contaminated with Campylobacter jejuni. Continue Reading
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05 Aug 2024
HHS announces new policies for underserved communities
The policies are intended to improve access to care for underserved and marginalized communities. Continue Reading
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31 Jul 2024
FDA accepts NDA for Vertex’s non-opioid pain drug
Vertex Pharmaceuticals revealed that the FDA has accepted its NDA for suzetrigine, a non-opioid pain inhibitor. Continue Reading
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29 Jul 2024
Abbott issues urgent correction for FreeStyle Libre 3 sensors
Abbott has identified a defect in certain FreeStyle Libre 3 sensors that may cause incorrect high glucose readings, which could pose health risks for users. Continue Reading
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24 Jul 2024
PBM execs defend role amidst bipartisan drug price scrutiny
PBM executives defended their role in a House hearing as lawmakers criticized their influence on high drug prices. Continue Reading
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17 Jul 2024
FDA, FTC work to protect consumers against copycat food containing THC
In a recent joint news release, the FDA and FTC outlined strategies for protecting consumers from companies illegally selling copycat foods containing THC. Continue Reading
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10 Jul 2024
FDA updates guidance for addressing medical misinformation
The updated guidance includes recommendations for industry members willing to address medical misinformation related to their products voluntarily. Continue Reading
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02 Jul 2024
FDA assures safety of commercial milk supply from H5N1 HPAI
After conducting a study to simulate commercial milk processing, the FDA is assuring the public that the commercial milk supply is safe from H5N1 HPAI. Continue Reading
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01 Jul 2024
Potential listeria contamination prompts spinach product recall
Solata Foods LLC issued a recall on its fresh spinach products sold in New York, citing potential Listeria monocytogenes contamination. Continue Reading
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27 Jun 2024
FDA issues warning letter to Bimbo Bakeries for incorrect food labeling
The FDA letter notes that multiple products are misbranded, listing allergens not in the product. Continue Reading
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21 Jun 2024
Expanding access to hepatitis C treatment would reduce healthcare cost
A report from the Congressional Budget Office estimates that doubling hepatitis C treatment among Medicaid enrollees could save $7 billion. Continue Reading
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20 Jun 2024
FDA approves Merck’s newest pneumococcal vaccine
The new vaccine is thought to protect against approximately 85% of invasive pneumococcal disease in adults 65 years of age and older. Continue Reading
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13 Jun 2024
Multi-agency task force collaborates to address illegal e-cigarettes
The United States FDA and the Department of Justice will collaborate to fight against the unlawful distribution and sale of e-cigarettes. Continue Reading
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12 Jun 2024
FDA advisory panel votes in favor of Lilly’s Alzheimer’s drug
On June 10, a panel of FDA advisors unanimously voted in favor of approving Eli Lilly’s new Alzheimer’s disease drug, donanemab. Continue Reading
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06 Jun 2024
FDA advisory panel votes against MDMA therapy for PTSD
In a 10 to 1 vote, the FDA advisory panel on MDMA therapy for PTSD decided that the benefits of the treatment do not outweigh the risks. Continue Reading
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30 May 2024
FDA approves first interchangeable biosimilar for Soliris
Newly approved Bkemv, manufactured by Amgen, can now be used interchangeably with AstraZeneca’s Solaris for PNH and aHUS. Continue Reading
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22 May 2024
FDA approves biosimilars for macular degeneration, other eye diseases
The FDA approved Yesafili and Opuviz as interchangeable biosimilars for Eylea to treat multiple eye conditions, including macular degeneration. Continue Reading
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16 May 2024
FDA approves Roche’s self-collected HPV tests
This week, the FDA approved the first HPV self-collection solution in the US, which will expand options and access to screening. Continue Reading
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15 May 2024
49% of illicit fentanyl seizures are in pill form
An NIH-funded study revealed that law enforcement seized over 115 million pills with illicit fentanyl, accounting for 49% of all fentanyl seizures. Continue Reading
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07 May 2024
Senate Finance Committee combats drug shortages via draft legislation
A draft legislation from Ron Wyden and Mike Crapo of the Senate Finance Committee proposes solutions to economic factors contributing to drug shortages. Continue Reading
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02 May 2024
FDA opens discussion on optimizing advisory committees to the public
An announcement from the administration notes that it plans to consider public engagement for the optimization, use, and processes of advisory committees. Continue Reading
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26 Apr 2024
Stop Clopez Corp voluntarily recalls herbal dietary supplement
After an FDA analysis found that the male sexual enhancement supplements contained Nortadalafil, the company issued a voluntary recall. Continue Reading
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Feature
22 Apr 2024
Evaluating the safety profile of mifepristone
Evaluating the safety profile of mifepristone amid legal debates and access challenges underscores its importance in reproductive healthcare. Continue Reading
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19 Apr 2024
CDC, FDA investigate harmful counterfeit Botox
Counterfeit Botox has been linked to 19 illnesses and 9 hospitalizations across 9 states. Continue Reading
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18 Apr 2024
Heart devices linked to injuries, deaths receive FDA's most serious recall
The FDA has issued the highest recall classification for Abbott’s HeartMate II and HeartMate 3 devices linked to 100s of injuries and 14 deaths. Continue Reading
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Feature
16 Apr 2024
Exploring 5 types of intellectual property protections in pharma
Patents, trademarks, copyrights, trade secrets, and regulatory exclusivities offer intellectual property protections to pharmaceutical companies. Continue Reading
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15 Apr 2024
EPA finalizes chemical plant clean air standards
The EPA has issued a final ruling to regulate toxic air pollution from chemical plants, supporting the Cancer Moonshot Initiative. Continue Reading
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11 Apr 2024
Abbott provided $650,000 to FDA advisory panel members
Among the 14 voting members on the Abbott TriClip G4 System, 10 members of the FDA advisory panel received payments from Abbott totaling $650,000. Continue Reading
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03 Apr 2024
Rising adult melatonin use sparks concern over unsupervised child exposure
Rising adult melatonin use coincides with unsupervised child exposure, prompting urgent CDC calls for preventive action to protect public health. Continue Reading
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28 Mar 2024
FDA issues warning letters for unapproved topical pain relief products
The FDA issued warning letters to six companies, highlighting the dangers of unauthorized topical pain relief products and warning consumers. Continue Reading
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27 Mar 2024
SCOTUS to issue a decision on mifepristone in the coming months
Following yesterday’s hearing, experts predict that SCOTUS will issue a final ruling on mifepristone access in the coming months, likely siding with the FDA. Continue Reading
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19 Mar 2024
FDA ODAC favors 2 CAR T-cell therapies for multiple myeloma
The advisory committees voted in favor of Abecma and Carvykti for patients with multiple myeloma. Continue Reading
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14 Mar 2024
FDA requests $7.2 billion from Biden’s 2025 fiscal year budget
The request will fund enhanced food safety and nutrition, address shortages and supply chain challenges, and modernization efforts. Continue Reading
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12 Mar 2024
FDA expands Wegovy indications, adding cardiovascular disease
Last week, the FDA expanded Wegovy’s approval, allowing doctors to prescribe it to reduce the risk of cardiovascular death, heart attack, and stroke. Continue Reading
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01 Mar 2024
CDC Recommends Additional COVID-19 Vaccine for Elderly Populations
The CDC’s ACIP recommends that individuals 65 and older get another 2023–2024 formula COVID-19 vaccine dose. Continue Reading
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16 Feb 2024
FDA Approves New First-Line Treatment for Pancreatic Adenocarcinoma
On February 13, 2024, the FDA approved irinotecan liposome as a first-line treatment for metastatic pancreatic adenocarcinoma. Continue Reading
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24 Jan 2024
NY Charges Midwife $300K for Falsifying Vaccine Records
New York State Department of Health issued Nassau County midwife $300K for falsifying vaccine records and administering nearly 12,500 fake immunizations. Continue Reading
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12 Jan 2024
FDA Investigates the Safety of GLP-1 Weight Loss Drugs
A recent update published by the FDA revealed that the ongoing investigation into GLP-1 drugs has not identified a causal link between their use and suicidal thoughts. Continue Reading
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11 Jan 2024
FDA Recalls 3 IV Drugs from Leiters Health for Potential Superpotency
Last week, the FDA announced a voluntary recall of 33 lots of intravenous drug bags, including vancomycin, phenylephrine, and fentanyl IV bags. Continue Reading
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10 Jan 2024
Online Pharmacies Under Scrutiny for Lax Safety Checks, Endangering Patients
An investigation into the online pharmaceutical industry reveals lax regulations, endangering patient safety. Continue Reading
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14 Dec 2023
FDA Launches New Advisory Committee for Genetic Metabolic Diseases
The new FDA Genetic Metabolic Diseases Advisory Committee will evaluate medical products for related conditions and provide regulatory recommendations. Continue Reading
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13 Dec 2023
FDA Approves First CRISPR-Based Gene Therapy
Vertex Pharmaceuticals secured the first FDA approval for a CRISPR-based gene therapy with their sickle cell drug, Casgevy. Continue Reading
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11 Dec 2023
Price Transparency Healthcare Policies Reduce Out-Of-Pocket Costs
Healthcare policies should focus on increased price transparency in the payment systems to reduce out-of-pocket drug costs for patients. Continue Reading
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08 Dec 2023
EPA Proposes Lead Pipe Removal to Minimize Human Exposure
A newly proposed rule by the EPA outlines plans to replace all lead pipes with copper pipes nationwide, minimizing the health effects of lead exposure through drinking water. Continue Reading
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07 Dec 2023
34% of Conventional Baby Food Contains Pesticides
A study from the Environmental Working Group revealed that 34% of conventional baby foods contained pesticides, compared to 0% of organic baby foods. Continue Reading
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01 Dec 2023
FDA Publishes Drug Safety Communication for Antiseizure Drugs
The risks include severe and potentially life-threatening reactions such as rash, fever, swollen lymph nodes, and organ damage. Continue Reading
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30 Nov 2023
FDA Approves First Therapy for Progressing Desmoid Tumors
The approval of Ogsiveo marks the first treatment of this locally aggressive and rare subtype of soft tissue sarcomas. Continue Reading
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28 Nov 2023
US States, Cities Sue Insulin Makers Over Shortages, High Prices
United States jurisdictions file lawsuits against insulin makers, alleging a conspiracy to raise prices and worsen shortages. Continue Reading
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22 Nov 2023
WHO Urged Actions to Stop Antimicrobial Resistance
During World Antimicrobial Resistance Awareness Week, the WHO urges appropriate use of antimicrobials to minimize resistance. Continue Reading
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21 Nov 2023
FDA Approves Truqap, Faslodex for HR-Positive Breast Cancer
AstraZeneca announced the approval on November 17, 2023, based on a phase 3, double-blind, randomized clinical trial. Continue Reading
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17 Nov 2023
FDA Announces Kilitch Healthcare India Eyedrop Recall
Implicated in the warning letters issued in October 2023, Kilitch Healthcare India has voluntarily recalled eyedrops distributed to retailers nationwide. Continue Reading
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15 Nov 2023
FDA Issues Warning Letter to Amazon with Concerns About Eye Drop Sales
Yet again, the FDA has issued warning letters to another eye drop retailer, identifying violations on seven eyedrops. Continue Reading
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14 Nov 2023
What to Know About the 2023 Eyedrop Recalls, Understanding the Risks
With multiple recalls reported this year, clinicians and patients must understand the risks associated with the 2023 eyedrop recalls. Here’s what to know. Continue Reading
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13 Nov 2023
FDA Approves New Weight Loss Drug: Zepbound
Adding to the weight loss drugs list, the FDA has approved Zepbound, a GIP and GLP-1 agonist. Continue Reading
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02 Nov 2023
26 More Eyedrops Recalled from CVS, Target, Walmart, Rite Aid and More
The eye drops supplied by Velocity Pharma may be contaminated due to unsanitary manufacturing conditions. Continue Reading
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30 Oct 2023
FDA Issues Warning About Probiotics Sold for Preterm Infants
The organization has sent letters to healthcare providers and warning letters to two companies illegally selling these products. Continue Reading
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26 Oct 2023
CDC Urges Rationing of New Antibody Shot for Infant RSV Protection
CDC advises rationing Beyfortus due to high demand, prioritizing high-risk infants, and suggests Synagis for eligible cases. Continue Reading
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25 Oct 2023
FDA Reviews AstraZeneca's Self-Administered Flu Vaccine, FluMist
AstraZeneca’s self-administered vaccine could offer a needle-free nasal spray option for eligible patients, adding a new dimension to the fight against influenza. Continue Reading
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23 Oct 2023
NIH Alters Grant Review Process, Focusing on Scientific Merit
The NIH announced it is taking steps to eliminate bias in its grant review process to maintain a focus on scientific merit. Continue Reading
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20 Oct 2023
FDA Approves Non-Opioid Painkiller for Mild-to-Moderate Pain
The New Drug Application was approved on October 18, 2023, based on phase 3 clinical trial results. Continue Reading
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19 Oct 2023
FDA Proposes Ban on Formaldehyde Hair Smoothing, Straightening Products
The FDA proposes a ban after multiple studies have linked formaldehyde and formaldehyde-releasing chemicals in hair products to uterine cancer. Continue Reading
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16 Oct 2023
A Look at California’s Newest Bans on Chemicals in Food
The California Food Safety Act bans certain additives in the food supply that the FDA has not prohibited nationwide. Continue Reading
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12 Oct 2023
Online Vendors Sell Unapproved GLP-1 Drugs, FDA Issues Warnings
The FDA issued warning letters to two online vendors selling unapproved versions of GLP-1 drugs used for weight loss. Continue Reading
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11 Oct 2023
DEA Extends Telemedicine Prescription of Controlled Medicines
Last week, the DEA and HHS announced that they would extend the COVID-19 telemedicine prescription flexibilities for controlled substances until the end of 2024. Continue Reading
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06 Oct 2023
FDA Issues Guidance on Drug Development for Stimulant Use Disorders
Once finalized, the draft guidance will provide recommendations for clinical trial design and drug development protocols to manage stimulant use disorders. Continue Reading
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05 Oct 2023
CDC Recommends Doxycycline PEP to Prevent STIs
The proposed guidelines were issued on October 2, 2023, and will be open to commentary until November 16, 2023. Continue Reading
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04 Oct 2023
FDA Authorizes Novavax COVID-19 Vaccines for Circulating Variants
The emergency use authorization authorizes the vaccine to protect against the XBB.1.5 variant in individuals ages 12 and older. Continue Reading
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03 Oct 2023
How Quality Assurance Shapes US Drug Manufacturing
Quality assurance in US drug manufacturing ensures safe and effective medications, safeguarding patient health. Continue Reading
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15 Sep 2023
FDA Issues Warning Letters for Marketing Unapproved Ophthalmic Drugs
Eight companies marketing eye products violated federal marketing guidelines. Continue Reading
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13 Sep 2023
CDC Recommends Updated COVID-19 Boosters This Fall/Winter
The updated boosters, which include a monovalent compound that is effective against XBB.1.5, were approved on Monday. Continue Reading
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12 Sep 2023
Understanding Implications of Pharmacogenomic on Prescribing
Pharmacogenomic research can enhance personalized medicine, optimize drug efficacy, improve safety, reduce treatment costs, and inform research and development. Continue Reading
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08 Sep 2023
CDC Updates Recommendations for Pneumococcal Vaccine for Adults
The updated guidelines recommend PCV15 or PCV20 for adults over 18 who only received PPSV23. Continue Reading
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07 Sep 2023
HHS Petitions DEA to Reclassify Cannabis as a Schedule III Drug
Leaked HHS documents revealed that the organization hopes to reclassify cannabis from a Schedule I to Schedule III drug. Continue Reading
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01 Sep 2023
First FDA-Approved Biosimilar for Multiple Sclerosis Mimics Tysabri
The FDA recently approved Tyruko, the first biosimilar for Tysabri, a multiple sclerosis treatment. Continue Reading
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31 Aug 2023
FDA Issues 15 Warning Letters to Online Retailers Selling E-Cigarettes
The retailers are given 15 days to discontinue the sale of illegal e-cigarettes that appeal to the younger populations. Continue Reading
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29 Aug 2023
CMS Announces First Drugs for Medicare Price Negotiations
Drug price negotiations will widen access to medications at the expense of pharmaceutical profits for manufacturers. Continue Reading
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25 Aug 2023
CDC Follows Listeria Outbreak After Ice Cream Recall
A recent CDC update identified two illnesses and hospitalization from a Listeria outbreak in ice cream. Continue Reading
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22 Aug 2023
FDA Approves RSV Vaccine for Pregnant Individuals as Prevention Tool
Abrysvo will be used to prevent RSV infections in infants under 6 months by administering the drug to pregnant individuals between 32 and 36 weeks. Continue Reading
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09 Aug 2023
Red Cross Adopts FDA’s Blood Donation Policies to Expand Eligibility
The organization has now adopted policies proposed by the FDA, expanding eligibility and easing restrictions on LGBTQ donors. Continue Reading
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08 Aug 2023
FDA Clears IND for New Parkinson’s Disease Treatment Using IPSCs
With IND clearance, Aspen Neuroscience will be eligible to start early-phase clinical trials of the therapy. Continue Reading
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07 Aug 2023
FDA Approves Zuranolone for Postpartum Depression
While the FDA approved zuranolone for postpartum depression, approval for major depressive disorder is still in the air. Continue Reading
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31 Jul 2023
FDA Approves Second OTC Naloxone for Opioid Overdose Management
The FDA has approved RiVive, a naloxone nasal spray, as the second OTC emergency overdose medication for opioid overdose management. Continue Reading
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28 Jul 2023
FDA Issues Draft Guidance on Devices for Opioid Use Disorder
The FDA recently issued a draft of the Clinical Considerations for Studies of Devices Intended to Treat OUD as part of its overdose prevention framework. Continue Reading
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25 Jul 2023
Top 10 Myths About Medicinal and Recreational Cannabis
Addressing the top 10 myths about medicinal and recreational cannabis promotes accurate information, reduces stigma, and ensures safe and responsible use. Continue Reading
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18 Jul 2023
Newly Approved Monoclonal Antibody Prevents RSV in Babies and Toddlers
The FDA has approved Beyfortus, a monoclonal antibody for preventing RSV in babies and toddlers. Continue Reading
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13 Jul 2023
FDA Approves Over-the-Counter, Nonprescription Birth Control
In a landmark event, the FDA approved the first-ever over-the-counter, nonprescription oral birth control, Opill. Continue Reading
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12 Jul 2023
GSK Launches New Platform for Tracking Adult Vaccination Rates
GSK recently launched a new platform for adult vaccine tracking as part of its COiMMUNITY Initiative for improving adult vaccination. Continue Reading
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12 Jul 2023
White House National Response Plan Addresses Xylazine, Fentanyl Risk
In light of recent overdose trends, the White House has issued a national response plan that addresses the risks of fentanyl and xylazine. Continue Reading
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11 Jul 2023
Cipla Albuterol Sulfate Inhalation Aerosol Voluntarily Recalled
Cipla voluntarily recalled six batches of its albuterol sulfate inhalation aerosol due to a container defect. Continue Reading
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07 Jul 2023
Biogen and Eisai Secure Traditional FDA Approval for Lequembi
After reviewing the supplemental Biologics License Application, the FDA granted Biogen and Eisai’s Lequembi traditional approval. Continue Reading
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05 Jul 2023
Older and Immunocompromised Adults Advised to Get RSV Vaccine
Updated CDC recommendations advise older and immunocompromised adults to get the newly available RSV vaccines. Continue Reading
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30 Jun 2023
FDA Adds Another Frozen Fruit to Recall List: Listeria Contamination
Adding to a series of frozen fruit recalls linked to hepatitis A, the FDA has added some frozen pineapples to the recall list due to listeria contamination. Continue Reading
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29 Jun 2023
WMIF: FDA Commissioner Discusses Revamping Accelerated Approval
At the 2023 World Medical Innovation Forum (WMIF), the FDA Commissioner discussed revamping accelerated approval. Continue Reading
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28 Jun 2023
Biopharmaceutical Leaders Challenge the IRA’s Innovation Implications
As part of a panel at the WMIF, biopharmaceutical leaders challenged the IRA for its implications on and perceived challenges in innovation. Continue Reading
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27 Jun 2023
FDA Issues Guidance on Psychedelic Drug Use in Clinical Trials
The FDA has issued draft guidance on psychedelic drug use in clinical trials for the first time. Continue Reading
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22 Jun 2023
FDA Grants Bluebird Bio Priority Review of BLA for SCD Treatment
Bluebird Bio gets FDA priority review for SCD treatment in patients 12+ with vaso-occlusive history. Continue Reading
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21 Jun 2023
FDA Approves New Pediatric Medication for Type 2 Diabetes
FDA approves empagliflozin, a new class of pediatric drugs for type 2 diabetes, providing an alternative to metformin. Continue Reading
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20 Jun 2023
FDA Announce Additional Frozen Fruit Recall: Hepatitis A Contamination
FDA announces new recalls on frozen fruit due to potential hepatitis A contamination, following recent recalls. Continue Reading
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16 Jun 2023
FDA Provides Guidance for Preventing Contamination in Tattoo Ink
Following a previous safety alert, the FDA provided draft guidance for preventing and reducing microbial contamination in the tattoo ink in a recent press release. Continue Reading