House lawmaker raises new concerns over FDA's ultra-fast drug review program

A Democratic lawmaker raised new concerns about a Food and Drug Administration program designed to drastically shorten the ...
Fierce Pharma

FDA rejects AZ's subQ Saphnelo, but company expects quick turnaround for new approval decision

AstraZeneca has hit what appears to be a minor speed bump in gaining clearance in the U.S. for its subcutaneous (SC) version ...
STAT

FDA officials push for long-term monitoring of autoimmune patients receiving CAR-T therapy

FDA officials are advising drug developers to study the long-term effects of using CAR-T in autoimmune conditions out of ...

Meet AuraWell — FDA-Cleared, Clinical Grade PEMF Recovery At Home

In a regulatory milestone, the FDA clears AuraWell’s PEMF technology as the first over-the-counter frequency therapy device for at-home recovery.
CURE

FDA Clears Phase 3 Trial of iSCIB1+ for Advanced Melanoma Treatment

The FDA approved Scancell's phase 3 trial of iSCIB1+ for advanced melanoma, focusing on progression-free survival as a ...
BioSpace

FDA Action Alert: Sanofi/Regeneron, Merck, REGENXBIO and More

In what is shaping up to be a back-loaded month, the FDA is set to release a slew of regulatory decisions in February, ...

AstraZeneca’s Initial Application for Lupus Injection Turned Down by FDA

The company is working with the U.S. regulator to move forward with an updated application, adding a decision is expected in ...

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 ...

FDA, CDC investigate salmonella outbreak tied to recalled supplements that has sickened 65 in 28 states

Federal health officials are investigating a multi-state outbreak of two strains of salmonella connected to two recalled supplementary powders.

Invivyd Aligns with the U.S. FDA on LIBERTY, a Phase 3 Trial to Evaluate the Safety of VYD2311 Antibody Versus mRNA COVID Vaccine, and to Characterize the Safety and Immunology ...

LIBERTY is part of the Company’s broader REVOLUTION clinical program designed to elaborate the profile of monoclonal antibody-mediated ...

Grocery store chain issues recall for thousands of gallons of water due to startling FDA report: 'Floating black foreign substance'

The Food and Drug Administration indicated that a "floating black foreign substance in the product" precipitated the multistate recall, but the agency neither identified the material nor provided any ...

Pfizer weight-loss drug data raises questions about side effects, shares fall

By Michael Erman and Mrinalika Roy Feb 3 (Reuters) - Pfizer on Tuesday released trial data on a high-profile obesity drug from its recent $10 billion Metsera purchase that raises questions about its ...