FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA raises questions in adcomm briefing docs for Roche's Polivy label expansion

3 years ago

FDA inspection uncovers cherry-colored antibiotic residue on equipment at Teva's New Jersey site

3 years ago

FDA says no adcomm planned for Biogen, Sage's depression drug

3 years ago

Mesoblast’s aGVHD cell therapy will get another shot at the FDA

3 years ago

Makena saga nears an end as Covis requests to pull controversial preterm birth drug

3 years ago

Where are all the generic inhalers for asthma and COPD? Researchers call for patent and FDA reforms

3 years ago

Rare disease trials can't find enough patients. It's forcing the FDA to rethink its approach

3 years ago

Biden proposes extending Medicare price negotiations to more drugs

3 years ago

FDA delays review of BioMarin's hemophilia gene therapy after data update

3 years ago

FDA axes diagnostic requirement for Lilly's Verzenio + endocrine therapy in certain breast cancer patients

3 years ago

Accelerated approval incoming? Moderna 'hopeful' for personalized cancer vaccine

3 years ago

Thousands of complaints and lab records in 'bags of scrap': FDA inspects Cipla site in India

3 years ago

July decision date set for full approval of Eisai's Alzheimer's drug, with an adcomm coming too

3 years ago

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

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