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A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024.

latest-news

FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain.

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FDA Warning Letters Surge in FY2025, Report Finds

A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, issuing 303 Warning Letters to companies involved with drugs and biologics — up 59% from 190 letters in FY2024.

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FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season use a trivalent formulation, targeting two influenza A strains and one influenza B strain.

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Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12

Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B12 can produce an unknown impurity from a chemical reaction between the two active ingredients.

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BridgeBio Data on BBP-418 in Limb-Girdle Muscular Dystrophy

BridgeBio says its investigational therapy BBP-418 showed consistent clinical benefit and a favorable safety profile in an interim analysis of the Phase 3 FORTIFY trial in patients with limb-girdle muscular dystrophy.

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Animal Drugs

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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...

medical-devices
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Sangamo Begins Rolling BLA for Fabry Gene Therapy

Sangamo Therapeutics begins a rolling BLA submission seeking accelerated approval of its experimental Fabry disease gene therapy, following result...

Biologics

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medical-devices
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FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

FDA’s Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 2026–2027 U.S. season us...

medical-devices
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FDA Flags Safety Reporting Lapses at U.K. Clinical Trial Site

FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of study records during ...

medical-devices
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Updated Guidance Clarifies Biosimilar Development Requirements

FDA posts an updated draft guidance outlining new and revised recommendations for companies developing biosimilar products.

medical-devices
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Incyte Gets ‘Complete Response’ Over Catalent Inspection Issues

FDA sends Incyte a complete response letter for its supplemental BLA for Zynyz (retifanlimab-dlwr) injection that cited inspection findings (not spec...

FDA General

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medical-devices
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FDA Warning Letters Surge in FY2025, Report Finds

A regulatory consulting firm's report finds that FDA sharply increased enforcement activity against drugmakers and distributors in fiscal year 2025, i...

medical-devices
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FDA Opens New, Searchable Adverse Event Platform

FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on one searchable platf...

medical-devices
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Public Trusts FDA Career Scientists Over Agency Leadership

A new national survey sees Americans expressing significantly greater confidence in FDA career scientists than in the leaders who oversee them.

medical-devices
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Guidance Urges Comprehensive Responses to Inspection Findings

FDA issues a draft guidance outlining how drug manufacturers should respond to inspection findings documented in an FDA Form 483, urging companies to ...

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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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Lilly Warns of Risk in Compounded Tirzepatide/Vitamin B12

Eli Lilly issues a public warning that its testing found that compounded tirzepatide with vitamin B1...

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BridgeBio Data on BBP-418 in Limb-Girdle Muscular Dystrophy

BridgeBio says its investigational therapy BBP-418 showed consistent clinical benefit and a favorabl...

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Attorneys Discuss New FDA Draft NCI Guidance

Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and w...

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Continue Modernizing Foreign Inspections: Study

Academic researchers call on FDA to continue to modernize its foreign drug inspection program and ov...

Marketing

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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...

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Cobenfy Ad Letter Signals Tight Limits on DTC Claims: Attorneys

A December FDA violation letter targeting a schizophrenia drug advertisement from Bristol Myers Sq...

Medical Devices

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FDA OKs J&J’s Tecnis PureSee Lens for Cataract Surgery

FDA approves Johnson & Johnson’s Tecnis PureSee Intraocular Lens, a new extended depth-of-focus lens...

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FDA Draft Guidance for Medical Devices Intended for Weight Loss

FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - P...

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Advita Ortho Hit with 7 QS Violations

FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its productio...

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FDA Issues Early Alert on Erbe Flexible Cryoprobes

FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprob...