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FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device violations in its work as a specification developer.

latest-news

FDA asks to look at Rezolute’s Phase 3 data after the company’s trial of ersodetug missed the primary endpoint, with the hope of charting a clear path forward for the stalled program.

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Multiple Violations at Longhorn Vaccines and Diagnostics

FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device Reporting, and Adulterated and Misbranded Device violations in its work as a specification developer.

motusgi
FDA Asks for Rezolute’s Ersodetug Data After Trial Miss

FDA asks to look at Rezolute’s Phase 3 data after the company’s trial of ersodetug missed the primary endpoint, with the hope of charting a clear path forward for the stalled program.

motusgi
FDA Open to Single Phase 3 for Netherton Syndrome Drug

Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare disease candidate QRX003, indicating that a single Phase 3 trial could be sufficient to support approval in Netherton Syndrome.

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Beam Eyes Accelerated Approval for Genetic Disease Therapy

Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to seek accelerated approval for treating Alpha-1 Antitrypsin.

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Animal Drugs

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medical-devices
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Enforcement, Advertising Oversight Shape Regulatory Landscape: Legal Update

A legal update from ArentFox highlight several emerging regulatory and enforcement developments at FDA thatare expected to have significant implicatio...

medical-devices
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Partial Hold on Myotonic Dystrophy Type 1 Therapy

FDA places a partial clinical hold on a mid-stage U.S. trial of PepGen Inc.’s experimental therapy for myotonic dystrophy Type 1.

medical-devices
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FDA Warns Elanco Animal Health About Pradalex Ads

The Center for Veterinary Medicine warns Elanco Animal Health about false and misleading claims in promotional materials for its Pradalex that treats ...

medical-devices
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Antimicrobial Drug Duration of Use Guidance

FDA publishes a guidance with recommendations for how sponsors of animal drugs may facilitate changes to the approved conditions of use of specific ty...

Biologics

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medical-devices
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Ocugen Reports Positive Phase 2 Data for Vision Loss Gene Therapy

Ocugen announces positive 12-month results from a mid-stage clinical trial of its experimental gene therapy OCU410, aimed at treating geographic atrop...

medical-devices
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Pfizer, Valneva to File BLA for Lyme Disease Vaccine

Pfizer and Valneva plan to submit a BLA for their investigational Lyme disease vaccine candidate based on data demonstrating more than 70% efficacy in...

medical-devices
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Uncertainty for Gene Therapy, Rare Disease & Vaccines in Prasad Exit Wake

CBER director Vinay Prasad’s departure at the end of next month raises questions across the biotechnology sector about how the agency’s approach to va...

medical-devices
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GSK’s Arexvy RSV Vaccine for High-Risk Adults Ages 18–49

FDA expands the approved use of GSK’s Arexvy, a respiratory syncytial virus accine that now includes the in adults aged 18 to 49 who are at increased ...

FDA General

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medical-devices
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More Conflict of Interest Transparency Needed: GAO

The Government Accountability Office recommends that FDA take steps to publicly disclose how it resolves conflict of interest and appearance issues fo...

medical-devices
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Experts Urge 32 FDA Transparency Reforms in New JAMA Viewpoint

Public health experts call for sweeping reforms to improve FDA’s transparency, arguing that longstanding gaps in disclosure persist despite recent pro...

medical-devices
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FDA Updates Guidance on Pyrogen and Endotoxin Testing

FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and medical devices greater...

medical-devices
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Senators Demand HHS Reverse Autism-Related Web Site Changes

A group of U.S. senators is pressing HHS to reverse recent changes to FDA and other federal health Web sites, warning that altered guidance on vaccine...

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Federal Register

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PDUFA Public Meeting for User Fee Reauthorization

Federal Register notice: FDA announces a 7/14 public meeting to discuss proposed recommendations for...

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Generic Drug Fee Program Reauthorization Meeting

Federal Register notice: FDA hosts a 7/11 public meeting on the reauthorization of the Generic Drug ...

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FDA Withdraws and Reissues 2 Guidances

FDA says it is withdrawing two recent final guidances on cell- and tissue-based products and reissui...

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CDER Continues Quality Management Program

Federal Register notice: FDA seeks drug manufacturing establishments to participate in the second ye...

Human Drugs

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FDA Asks for Rezolute’s Ersodetug Data After Trial Miss

FDA asks to look at Rezolute’s Phase 3 data after the company’s trial of ersodetug missed the primar...

motusgi
Read More
FDA Open to Single Phase 3 for Netherton Syndrome Drug

Quoin Pharmaceuticals says FDA has signaled openness to a streamlined development path for its rare ...

motusgi
Read More
Beam Eyes Accelerated Approval for Genetic Disease Therapy

Beam Therapeutics says it will advance its base-editing therapy BEAM-302 into pivotal development to...

motusgi
Read More
Adventa Nintedanib Petition Granted, Denied

FDA grants in part and denies in part an AdvantaPharma petition seeking specific requirements on AND...

Marketing

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Influencers’ Drug Promotions Pose Public Health Risks: JAMA

A new study published in JAMA Network Open highlights growing public health concerns over prescripti...

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Hims & Hers Super Bowl Ad Hit

The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of J...

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FDA DTC Ad Crackdown Raises Legal Issues: Attorneys

Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer pr...

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Neffy Broadcast Ad ‘False or Misleading’: OPDP

An FDA Untitled Letter cautions ARS Pharmaceutical about false or misleading claims for its Neffy na...

Medical Devices

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Multiple Violations at Longhorn Vaccines and Diagnostics

FDA warns Bethesda, MD-based Longhorn Vaccines and Diagnostics about Quality System, Medical Device ...

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QS Violations at IsoTis OrthoBiologics

FDA warns Irvine, CA-based IsoTis OrthoBiologics about Quality System violations in its production o...

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Warning Letter Cites ‘Right-to-Try’ Law

Two Mintz attorneys say a CDRH Warning Letter to a medical device sponsor of clinical research and c...

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LivaNova PMA OK’d for Sleep Apnea

FDA approves a LivaNova PMA for its aura6000 System, a novel implantable device designed to treat ad...