News

JD Supra12d
FDA Approves BLA for Novavax’s COVID-19 Vaccine
Novavax, Inc. (“Novavax”) announced that FDA approved its Biologics License Application (“BLA”) for Nuvaxovid™ for active ...
Hosted on MSN3mon
FDA vaccine advisory committee meeting has been canceled
The FDA's vaccine advisory committee meeting to prepare for next year's flu season has been canceled. Zelenskyy explains his position after disrupted meeting with Trump Former SpaceX employee ...
STAT3mon
FDA cancels vaccine advisory committee meeting
You can reach Lizzy on Signal at lizzylaw.53. The Food and Drug Administration canceled an upcoming vaccine advisory committee meeting to discuss influenza virus strains, according to committee ...
NPR3mon
The FDA has canceled an important upcoming meeting about vaccines
The FDA's Vaccines and Related Biological Products Advisory Committee was scheduled for next month. But the agency notified committee members that the meeting had been canceled. The Food and Drug ...
STAT2mon
A ‘conflict of interest-free’ FDA advisory committee policy is a terrible idea
Pitts, a former FDA associate commissioner, was the agency’s senior official in charge of advisory committees. During my time at the Food and Drug Administration, I was the senior official in ...
Hosted on MSN1mon
Capricor Therapeutics Stock Tumbles After FDA Confirms Intent To Hold Advisory Committee Meet For Deramiocel Approval: But Retail’s Optimistic
The company said the FDA is considering holding an advisory committee meeting, though the agency provided no official date. Capricor CEO Linda Marbán said the company has been “actively ...
Fierce Healthcare6mon
FDA advisory committee to roll up sleeves on generative AI this week
The FDA will hold its first Digital Health Advisory Committee (DHAC) meeting to discuss how the agency should review medical devices that rely on generative AI, like chatbots. The meeting will be ...
ABC News3mon
FDA cancels pivotal advisory meeting about next season's flu vaccine
"A planned March 13 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee on the influenza vaccine strains for the 2025-2026 influenza season in the northern ...
Yahoo Finance8mon
Company Statement on FDA Advisory Committee Meeting
13, 2024 (GLOBE NEWSWIRE) -- The Gastrointestinal Drugs Advisory Committee (GIDAC ... to today’s meeting, and will continue to work collaboratively with the FDA on behalf of patients.
Health Affairs11mon
The Future Of FDA Advisory Committees: Protecting Public Health And Preserving Public Trust
In recent years, several senior FDA officials have publicly hinted at possible advisory committee reforms, following increased attention to advisory committee meetings during the COVID-19 pandemic ...
FiercePharma3mon
FDA committee meeting scrapped, reports say, in 2nd vaccine-related scheduling disruption in as many weeks
The FDA's Advisory Committee calendar, updated as of Wednesday, shows no March meetings scheduled. As for the VRBPAC specifically, its "meeting materials" archive shows no content for the current ...
Yahoo Finance19d
Genentech Provides Update on FDA Advisory Committee Meeting on Columvi Combination for People With Relapsed or Refractory Diffuse Large B-cell Lymphoma
- Columvi is the first bispecific antibody to show a statistically significant and clinically meaningful 41% survival benefit in R/R DLBCL in the Phase III STARGLO study - - There is an urgent ...