FDA+ channel feed – Endpoints News

FDA+ channel feed

MiMedx receives FDA warning letter over Axiofill manufacturing concerns

Last year

Astellas hit with CRL for Claudin 18.2 drug due to third-party manufacturing issues

Last year

Senate health committee investigates inhaler manufacturers for high prices

Last year

FDA's Peter Marks says some secondary cancer cases after CAR-T therapy may be 'causal,' but benefits still outweigh risks: #JPM24

Last year

Califf and Marks call for clinicians to help address 'large volume' of vaccine misinformation

Last year

FDA lifts partial clinical hold on Innate's cancer drug after patient death linked to disease progression

Last year

House Republicans call on FDA to hand over info on internal scientific disagreements

Last year

Scoop: Resilience receives Form 483 due to mold at Canadian site, more layoffs anticipated

Last year

All the new drugs approved in 2023: Alzheimer's and gene therapy cap a five-year high

Last year

Dr. Reddy's, Torrent Pharma and Laurus Synthesis all land Form 483 letters following FDA inspections

Last year

Where are the adcomms? FDA has scheduled no drug or biologic meetings for 2024 so far

Last year

Pfizer gene therapy gets hemophilia B approval in Canada, setting stage for CSL rivalry

Last year

Updated: FDA says it has no plans for Israel-based office

Last year

Biden administration to use Defense Production Act to tackle drug shortages

Last year

Invivyd requests emergency use authorization for Covid-19 preventive antibody among immunocompromised

Last year

FDA seizes thousands of counterfeit Ozempic units, warns consumers not to use

Last year

IRA likely to lead to higher drug list prices and bigger rebates, Congressional Budget Office predicts

Last year

Iovance’s registrational lung cancer trial on hold after patient death

Last year

FDA declines to grant Amgen’s Lumakras full approval in lung cancer after negative advisory committee vote

Last year

Following FDA inquiry into CAR-T safety, agency adds warning on secondary cancers for Carvykti

Last year

FDA approves AstraZeneca, Ionis' ATTR drug as showdown with Alnylam heats up

Last year

Calliditas wins full approval for steroid drug in rare autoimmune disease

Last year

Pharma companies delist patents from FDA's Orange Book following FTC challenges

Last year

FDA findings at Moderna's Massachusetts facility don't reflect quality, safety concerns, company says

Last year

First page Previous page 35 36 373839 40 41 Next page Last page