FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA issues new guidance on wet AMD drug development

3 years ago

Walgreens decides against distributing abortion pill in some states — report

3 years ago

Q&A with Christine Baeder, new chair of the generic industry’s AAM

3 years ago

FDA rejects Covid-19 drug over uncertainties around small trial

3 years ago

'You are not the drug sponsor': FDA declines petition to anoint Cassava's drug as 'breakthrough'

3 years ago

FDA schedules advisory committee hearing for Lynparza prostate cancer application

3 years ago

FDA adopts ICH guidance on continuous manufacturing

3 years ago

Two for two: GSK follows Pfizer, secures adcomm thumbs-up for RSV vaccine in older adults

3 years ago

CBER director Peter Marks says FDA is growing to keep up with cell and gene therapies

3 years ago

Sarepta won't need FDA adcomm, boosting Duchenne gene therapy's odds

3 years ago

FDA rejects Cytokinetics' heart failure drug, but the biotech has a backup

3 years ago

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

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