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Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection process.

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In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.

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Report: Three Finalists Emerge in Next Commissioner Search

Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection process.

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FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.

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OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis

A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. received a higher proportion of the agency's most serious inspection classification than Indian plants in 2025.

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Dr. Reddy's Gets 7-Item FDA Form 483 After Biologics Inspection

FDA cites Dr. Reddy's Laboratories in a seven-observation Form 483 following a recent pre-license inspection of its biologics manufacturing facility in Bachupally, Hyderabad, India.

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Animal Drugs

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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

medical-devices
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FDA Guide on Developing Drugs for Pulmonary Tuberculosis

FDA posts updated guidance outlining how drugmakers should design clinical development programs for new tuberculosis treatments, emphasizing the need ...

Biologics

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medical-devices
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EC Opens Antitrust Probe into Sanofi's Flu Vaccine Marketing

The European Commission opens a formal antitrust investigation into whether Sanofi abused its dominant market position by allegedly conducting a misle...

medical-devices
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FDA Accepts Replimune's Resubmitted BLA for Advanced Melanoma

FDA accepts for review Replimune's BLA resubmission that is seeking accelerated approval of RP1 (vusolimogene oderparepvec) in combination with nivolu...

medical-devices
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Capricor's Duchenne Cell Therapy Set for Advisory Committee Review

FDA informs Capricor Therapeutics that it has scheduled an advisory committee meeting to review the company's BLA resubmission for deramiocel, an inve...

medical-devices
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JAMA Publishes Previously Blocked Covid-19 Vaccine Study

JAMA publishes a controversial Covid-19 vaccine effectiveness study, which was previously blocked from publication in a Centers for Disease Control an...

FDA General

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medical-devices
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Report: Three Finalists Emerge in Next Commissioner Search

Three candidates emerge as finalists to become the next FDA commissioner, according to an Axios report citing sources familiar with the selection proc...

medical-devices
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FDA WEBVIEW CLOSED JULY 4TH WEEK

In annual observance of the Fourth of July (Independence Day) holiday in the U.S., FDA Webview closes its news operations until Monday, July 6.

medical-devices
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FDA Policymaking May Return to Normalcy: Former FDAers

Speaking at the BIO 2026 convention, former FDAers criticize the informal way in which agency policy was made and announced under former commissioner ...

medical-devices
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Administration Weighs White House Aide for FDA Top Post

The Trump Administration considers White House health policy adviser Heidi Overton as a leading candidate to become the next FDA commissioner.

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Federal Register

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

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PhRMA Urges Changes to FDA’s ‘Plausible Mechanism’ Guidance

PhRMA urges FDA to broaden and clarify its draft guidance on individualized therapies, warning that ...

Human Drugs

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OAI Inspections at U.S. Drug Sites Surpassed India in 2025: Analysis

A new analysis of FDA inspection data suggests pharmaceutical manufacturing facilities in the U.S. r...

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Dr. Reddy's Gets 7-Item FDA Form 483 After Biologics Inspection

FDA cites Dr. Reddy's Laboratories in a seven-observation Form 483 following a recent pre-license in...

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FDA Declines to Approve Sobi Gout Therapy

FDA issues Sobi a Complete Response Letter on its BLA that is seeking approval of NASP (nanoencapsul...

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Lantheus Gets ‘Complete Response’ Letter for Tumor Imaging Agent

FDA issues Lantheus a Complete Response Letter for its NDA seeking approval for LNTH-2501 (gallium-6...

Marketing

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FDA Cites QOL Medical for Misleading Promotion of Sucraid

FDA issues an untitled letter to QOL Medical, alleging that promotional emails for its rare-disease ...

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FDA Drug Ad Crackdown Leads to More Spending on TV/Streaming Ads: Report

An FDA crackdown on allegedly deceptive prescription drug advertising leads to a sharp increase in p...

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DTC Crackdown Unfazed at Post-Makary FDA: Expert

DTC Perspectives CEO Bob Ehrlich says the sudden departure of former FDA commissioner Marty Makary i...

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Brukinsa TV Ad ‘False or Misleading’: OPDP

A CDER Office of Prescription Drug Promotion Notice of Violation cites a misleading BeOne Medicine T...

Medical Devices

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Agency Says Firm Submitted Invalid Data

FDA says it will not accept medical device test data generated by CCIC Huatongwei International Insp...

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Cotton Introduces Bill Targeting Chinese-Made Medical Devices

Sen. Tom Cotton (R-AR) introduces a bill that would require FDA to review and potentially recall Chi...

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Require IDE for Vena’s MicroAngioscope: Petition

Harmed Americans for Reform in Medical Device Safety petitions FDA to require an IDE for the Vena Mi...

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FDA Issues Early Alert on Abiomed Impella Introducer Kits

FDA issues an early alert warning healthcare providers about a potentially high-risk device issu...