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Experts Criticize New FDA Vaccine Skepticism Memo

Leading vaccine experts sharply criticize a new FDA memo that claims ten children died “after and because of” receiving Covid-19 vaccines between 2021 and 2024, and calls for stricter evidence requirements for vaccines.

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Human Drugs

FDA Deploys New AI Tool Under Efficiency Scheme

FDA says it has deployed advanced “agentic AI” capabilities to all agency employees, marking a major expansion of its artificial intelligence tools for regulatory and scientific work.

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Human Drugs

MannKind sNDA for Rapid-Acting Furoscix Autoinjector

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Medical Devices

Glycar Recalls 1 Lot of SJM Pericardial Patch

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FDA General

Guidance to Update Manufacturing Standards for Medical Gases

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Human Drugs

FDA Deploys New AI Tool Under Efficiency Scheme

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Experts Criticize New FDA Vaccine Skepticism Memo

Leading vaccine experts sharply criticize a new FDA memo that claims ten children died “after and because of” receiving Covid-19 vaccines between 2021 and 2024, and calls for stricter evidence requirements for vaccines.

motusgi
FDA Deploys New AI Tool Under Efficiency Scheme

FDA says it has deployed advanced “agentic AI” capabilities to all agency employees, marking a major expansion of its artificial intelligence tools for regulatory and scientific work.

motusgi
FDA Safety Alert on Some BD Alaris Pump Modules

FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certain Alaris Pump Modules if they have been dropped or severely jarred.

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Positive Data in Stargardt Disease Pivotal Trial

Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, marking the first successful pivotal trial in patients with Stargardt disease Type 1.

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Animal Drugs

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Sydnexis Pediatric Myopia Drug Meets Endpoints

Sydnexis says its SYD-101 drug to treat pediatric progressive myopia met both the primary and key secondary endpoints in the Phase 3 STAR trial.

medical-devices
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10/9 Vaccines Panel to Recommend Flu Strain Selection

FDA schedules a 10/9 Vaccines and Related Biological Products Advisory Committee meeting to make recommendations on the strain selection for influenza...

medical-devices
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Capsida Pauses Gene Therapy Trial After Death

Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...

medical-devices
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Guide on Biosimilar Formal Meeting Requsts

FDA releases a final guidance entitled Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA Products.

Biologics

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Experts Criticize New FDA Vaccine Skepticism Memo

Leading vaccine experts sharply criticize a new FDA memo that claims ten children died “after and because of” receiving Covid-19 vaccines between 2021...

medical-devices
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Questions About ‘Plausible Mechanism’ Pathway Continue: Attorneys

Three Ropes & Gray attorneys outline FDA’s new plausible mechanism pathway for approving personalized therapies and discuss questions that remain abou...

medical-devices
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Gene Therapy for Broader Spinal Muscular Atrophy Range

FDA approves Novartis’ Itvisma (onasemnogene abeparvovec-brve), a new formulation of a gene therapy for a broader age of spinal muscular atrophy patie...

medical-devices
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FDA Probes Death Associated With Takeda’s Adzynma

FDA investigates the death of a pediatric patient with congenital thrombotic thrombocytopenic purpura who developed neutralizing antibodies to the enz...

FDA General

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medical-devices
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Guidance to Update Manufacturing Standards for Medical Gases

FDA posts a draft guidance outlining updated current good manufacturing practice standards for medical gases.

medical-devices
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Study Finds Public Speaker Conflicts at FDA Panel Meetings

A new study of FDA advisory committee meetings reveals that a substantial portion of public speakers support drug approval, and many have financial co...

medical-devices
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White House Sought Resignation of Top Makary Aide

New reporting finds that the White House recently requested the resignation of a senior aide to FDA commissioner Marty Makary, highlighting growing fr...

medical-devices
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RFK Jr. reportedly Mulled Limiting Makary’s Authority

HHS secretary Robert F. Kennedy Jr. reviews options to scale back the operational role of FDA commissioner Marty Makary, including the possibility of ...

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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 Deploys New AI Tool Under Efficiency Scheme

FDA says it has deployed advanced “agentic AI” capabilities to all agency employees, marking a major...

motusgi
Read More
FDA Safety Alert on Some BD Alaris Pump Modules

FDA issues a safety alert after Becton Dickinson recently recalled (Class 1 device correction) certa...

motusgi
Read More
Positive Data in Stargardt Disease Pivotal Trial

Belite Bio reports positive topline results from the global Phase 3 DRAGON trial of tinlarebant, mar...

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Read More
MannKind sNDA for Rapid-Acting Furoscix Autoinjector

FDA accepts for review a MannKind supplemental NDA for its Furoscix ReadyFlow autoinjector, a fast-a...

Marketing

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FDA Flags AstraZeneca’s Farxiga TV Ad as Misleading

FDA cites a direct-to-consumer television advertisement for AstraZeneca’s Farxiga (dapagliflozin) ta...

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Oversight of Influencer Social Media Posts Hard: Researchers

University of Chicago researchers explain how difficult it will be to improve government oversight o...

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Create ‘Drug Facts’ Box for DTC Ads: Column

Two academic researchers urge FDA to require a Drug Facts box in direct-to-consumer ads so consumers...

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WLF Wants End to FDA TV Ad ‘Crackdown’

The Washington Legal Foundation calls on the FDA to stop its broad crackdown on drug TV advertising,...

Medical Devices

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Glycar Recalls 1 Lot of SJM Pericardial Patch

Glycar recalls (Class 1) certain batches of the SJM Pericardial Patch because affected units may fai...

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3 Former Magellan Execs Sentenced

The Department of Justice says a Massachusetts federal judge sentenced three former Magellan Diagnos...

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Baxter Recalls Life2000 Ventilators Over Cybersecurity Risks

Baxter recalls (Class 1) its Life2000 Ventilation System after the company discovered a cybersecurit...

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Alert on Misassembled Fresenius Infusion Pump Components

FDA issues an early alert warning about a potentially high-risk defect in certain Fresenius Kabi Ive...