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Interchangeable Product Development Strategy Outlined

FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.

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Many FDA-Ordered Postmarket Studies Not Done

A KFF Health News report documents hundreds of FDA-mandated postmarket studies whose reports are listed as delayed.

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Ultragenyx Gains Approval for Resubmitted Gene Therapy

FDA approves Ultragenyx Pharmaceutical’s Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome type A.

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FDA Commissioner Nominee Overton Gets 9/24 Confirmation Hearing

The Senate HELP Committee sets a 9/24 confirmation hearing on the nomination of Heidi Overton to be the next FDA commissioner.

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Animal Drugs

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Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
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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...

Biologics

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medical-devices
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Interchangeable Product Development Strategy Outlined

FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.

medical-devices
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Ultragenyx Gains Approval for Resubmitted Gene Therapy

FDA approves Ultragenyx Pharmaceutical’s Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome...

medical-devices
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FDA Clears Path for Rocket to Complete Pivotal Gene Therapy Trial

FDA agrees to key elements of Rocket Pharmaceuticals’ modified pivotal Phase 2 trial of RP-A501 for Danon disease, allowing the company to continue en...

medical-devices
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Scholar Rock’s Spinal Muscular Atrophy Therapy Approved

FDA approves a Scholar Rock BLA for Isembyld (apitegromab-mstn) injection to treat spinal muscular atrophy.

FDA General

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medical-devices
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FDA Commissioner Nominee Overton Gets 9/24 Confirmation Hearing

The Senate HELP Committee sets a 9/24 confirmation hearing on the nomination of Heidi Overton to be the next FDA commissioner.

medical-devices
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Senate Looks to Rush Overton’s FDA Head Nomination: Report

The Senate HELP Committee prepares to hold a confirmation hearing for FDA commissioner nominee Heidi Overton as soon as next week.

medical-devices
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Cassidy Remains Noncommittal on Overton FDA Nomination After Meeting

Senate HELP Committee chairman Bill Cassidy (R-La.) keeps mum on any potential support for FDA commissioner nominee Heidi Overton following a meeting ...

medical-devices
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FDA Seeks Input on Statistical Flexibility in Rare Disease Trials

FDA seeks input on whether traditional statistical standards should be modified for rare disease clinical investigations, including when the agency mi...

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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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...

Human Drugs

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Aquestive Therapeutics Refiles NDA for Anaphylm Sublingual Film

Aquestive Therapeutics resubmits its NDA for Anaphylm (dibutepinephrine) sublingual film for treatin...

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Data Don’t Show ‘Sustained, Structurally Rising CR Rate’: Report

FDA publishes a longitudinal study of CDER first-cycle NDA and BLA review decisions that it says ind...

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FDA Must Correct on Rare Diseases, Not Overcorrect: Column

A RealClear Health column urges FDA not to overcorrect as it reconsiders its approach to investigati...

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Rescind Filing of 2 Zydus Applications: Gilead

Gilead petitions FDA to rescind its acceptance for filing of two Zydus 505(b)(2) applications for dr...

Marketing

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FDA Hits Alar Pharmaceuticals Experimental Ketamine Promotion

FDA issues Alar Pharmaceuticals an untitled letter over promotional materials for its investigationa...

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FDA Promotion Crackdown Enters New Phase: Attorneys

Attorneys from Arnall Golden Gregory examine and offer advice on FDA’s intensified scrutiny of drug ...

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

Medical Devices

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Neptune Medical Robotic Endoscopy Cleared

FDA clears a Neptune Medical 510(k) for its Triton 1 System, a robotic system for next-generation fl...

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FDA Launches Medical Device Regulatory Reliance Portal

CDRH launches a new regulatory reliance portal to help foreign regulators use FDA medical device r...

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BMC Medical Recalls Sleep Apnea Machines

BMC Medical recalls its Luna G3 APAP (Model LG3600), an auto-adjusting positive airway pressure mach...

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GenAI Devices to See Increased Scrutiny: Law Firm

A Crowell & Moring analysis says FDA may increase regulatory scrutiny for user-facing GenAI-enabled ...