JD Supra

FDA PreCheck Pilot Program Launches, Clearing a Smooth Path to Approval

On February 1, 2026, the Food and Drug Administration (FDA) officially started accepting requests to participate in the FDA PreCheck pilot ...
Fierce Pharma

Amgen resists FDA request to pull rare disease drug Tavneos from the market

Amgen has denied a request by the FDA to voluntarily withdraw its rare disease drug Tavneos from the market, the company said ...

US FDA launches program to boost domestic drug manufacturing

By Ahmed Aboulenein WASHINGTON, Feb 1 (Reuters) - The U.S. Food and Drug Administration on Sunday began accepting requests to ...

Pro-life organization calls on HHS and FDA to suspend abortion pill approval, tighten safety rules

Live Action alleges "reckless distribution" of the abortion drug mifepristone, urging the Trump administration to suspend its ...

As Healthcare AI Changes On The Fly, FDA Reconsiders How To Keep It Safe

The FDA's approval process was designed for medical devices that stay largely the same after launch. Clinical AI does not ...
Marijuana Moment

West Virginia And Mississippi Lawmakers Approve Psychedelics Bills To Fund Ibogaine Trials Toward FDA Approval

The West Virginia House of Delegates and Mississippi House of Representatives have both approved bills to support research in ...
Fierce Pharma

FDA emphasizes drug ingredients, production pledges as it debuts PreCheck manufacturing program

The FDA laid out the qualifications a site would need to qualify for PreCheck on a webpage where companies can also submit ...
CURE

Pelareorep Receives FDA Fast Track Status for KRAS-Mutant Colorectal Cancer

The U.S. FDA has granted fast track status to pelareorep combination therapy for some KRAS-mutant, microsatellite-stable metastatic colorectal cancers.
Healio

Q&A: FDA update to biosimilar approval process may reduce time, cost of development

Please provide your email address to receive an email when new articles are posted on . An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy ...

Aquestive Therapeutics, Inc. (AQST) Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film Transcript

Discusses FDA Complete Response Letter and Next Steps for Anaphylm Epinephrine Sublingual Film February 2, 2026 8:00 ...
The Manila Times

Aquestive Therapeutics Announces FDA Issuance of Complete Response Letter for Anaphylm™

Deficiencies limited to packaging and administrationCompany believes it can rapidly resolve deficiencies and expects to resubmit as early as Q3 2026Remains well-capitalized and anticipates ending 2026 ...
Healio

FDA grants urcosimod 0.05% single-patient use for neuropathic corneal pain

The FDA has authorized urcosimod 0.05% for single-patient expanded access, or compassionate use, in a patient with ...