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U.S. House and Senate health committee leaders express concern about a new FDA review pilot program because it appears designed to enable corruption and reward President Trump’s allies with faster drug approvals.

latest-news

Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimer’s study after interim data showed its experimental antibody posdinemab failed to produce a statistically significant benefit.

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Democrat Lawmakers Probe FDA Voucher Program

U.S. House and Senate health committee leaders express concern about a new FDA review pilot program because it appears designed to enable corruption and reward President Trump’s allies with faster drug approvals.

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J&J Scraps Alzheimer’s Trial After Disappointing Data

Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimer’s study after interim data showed its experimental antibody posdinemab failed to produce a statistically significant benefit.

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Novo Nordisk’s Alzheimer’s Hopes Face Set Back

Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have failed to slow clinical progression in adults with early-stage symptomatic Alzheimer’s disease over two years.

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FDA Finds Sterility Lapses at NJ Drug Outsourcer

FDA investigators cite Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for multiple sterility and quality-control deficiencies after a two-week inspection.

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Animal Drugs

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medical-devices
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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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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...

medical-devices
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Makary, RFK, Jr., Feuding Over Vaccines: Politico

Politico reports that FDA commissioner Marty Makary and HHS secretary Robert F. Kennedy, Jr., are feuding over vaccine safety studies and staffing app...

medical-devices
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Promising Ziihera Data in Gastric Cancer Trial

Zymeworks reports that its HER2-targeted bispecific antibody Ziihera (zanidatamab-hrii) significantly improved outcomes for patients with HER2-positiv...

medical-devices
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FDA Approves First Interchangeable Perjeta Biosimilar

FDA approves Shanghai Henlius Biologics’ Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentech’s Perjeta (pertuzumab), a HER2-t...

FDA General

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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 ...

medical-devices
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FDA Previews Reforms as Pazdur Takes Over CDER

FDA commissioner Marty Makary and CBER director Vinay Prasad preview upcoming agency reforms during an FDA Direct podcast focused on the appointment o...

medical-devices
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Rising Concerns Over FDA Consistency, Transparency: Axios

An Axios report examines growing criticism of recent FDA actions that are fueling uncertainty among drug developers and weakening public confidence in...

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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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Democrat Lawmakers Probe FDA Voucher Program

U.S. House and Senate health committee leaders express concern about a new FDA review pilot program ...

motusgi
Read More
J&J Scraps Alzheimer’s Trial After Disappointing Data

Johnson & Johnson discontinues its Auτonomy Phase 2b Alzheimer’s study after interim data showe...

motusgi
Read More
Novo Nordisk’s Alzheimer’s Hopes Face Set Back

Novo Nordisk says data from two global Phase 3 trials of semaglutide (Ozempic and Wegovy) have faile...

motusgi
Read More
FDA Finds Sterility Lapses at NJ Drug Outsourcer

FDA investigators cite Molecular PharmaGroup, an outsourcing facility in New Providence, N.J., for m...

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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Alert on Misassembled Fresenius Infusion Pump Components

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

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FDA Issues Safety Notice on Nitric Oxide Delivery System

FDA issues a correction notice for NOxBOX Ltd.’s NOxBOXi Nitric Oxide Delivery System after reports ...

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Intersurgical Recalls Video Laryngoscope Due to Safety

Intersurgical recalls (Class 1) its i-View Video Laryngoscope, citing serious safety risks that coul...

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Medline Convenience Kit Recall is Class 1

FDA says the Medline 8/22 recall of three models of surgical convenience kits that were not steriliz...