FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA finally approves Reata's rare genetic disease drug

3 years ago

Pfizer's RSV vaccine for older adults nabs FDA adcomm recommendation

3 years ago

FDA neuroscience chief Billy Dunn, who led Aduhelm approval, will leave agency

3 years ago

Axsome says FDA wants more data for Alzheimer’s agitation label expansion, but readout to come sooner

3 years ago

Pfizer spinout SpringWorks gets FDA priority review for lead drug

3 years ago

Pfizer and BioNTech file BLA for Omicron-targeting Covid-19 vaccine

3 years ago

Full FDA hold derails clinical study of Fulcrum drug in a no good, very bad week for sickle cell R&D

3 years ago

Amneal Pharmaceuticals site in India receives 483 over cleaning and other quality issues

3 years ago

FDA approves Sanofi's factor VIII hemophilia A drug

3 years ago

Pfizer says RSV shot to protect infants may be available by 2023-24 cold and flu season

3 years ago

CMS to work closely with FDA on accelerated approval payment reforms

3 years ago

FDA to take another look at Akebia's rejected kidney drug

3 years ago

Alnylam gets an adcomm for Onpattro treatment in ATTR amyloidosis

3 years ago

Astellas' menopause drug hit by FDA delay after spending $97M on a priority review voucher

3 years ago

FDA clears Travere’s rare kidney disease drug, will come with REMS program

3 years ago

FDA approves Apellis' retinal disease drug as competitor expects August decision

3 years ago

FDA's No. 2 oncology official departs for biotech startup

3 years ago

FDA accepts Iveric Bio's NDA, grants priority review for GA drug

3 years ago

Merck seeks more approvals for infectious disease drug

3 years ago

FDA gives the OK to Chiesi for treatment of ultra-rare enzyme deficiency disease

3 years ago

UK could allow reciprocal drug approvals with US FDA as soon as 2024

3 years ago

Over-the-counter Narcan gets unanimous thumbs-up from FDA advisors

3 years ago

Moderna promises to provide vaccines at no out-of-pocket cost

3 years ago

Thousands of gene and cell therapies are inundating FDA reviewers as the agency tries to keep up

3 years ago

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