FDA+ channel feed – Endpoints News

FDA+ channel feed

Pharma company continues its FDA lawsuit spree, this time after agency denies fast-track designation

4 years ago

With topical approval, Dermavant looks to bring new standard-of-care to plaque psoriasis patients

4 years ago

Manufacturing concerns spur clinical hold on small biotech's Alzheimer's trial — shares plunge

4 years ago

House Republicans attack China-only data in FDA submissions, seek new investigation into research inspections

4 years ago

Updated: FDA calls for noninferiority trials for antibacterials, thanks to new drugs for resistant infections

4 years ago

Bristol Myers dusts off an old Celgene chemotherapy for use in children with a rare blood cancer

4 years ago

'I really don’t look back': Janet Woodcock on her transition away from drugs

4 years ago

Sanofi and Regeneron clear the finish line in an inflammatory esophagus disease, leaving Takeda in the dust

4 years ago

Trying to shake up the Parkinson's paradigm, AbbVie submits NDA for continuous, 24-hour infusion therapy

4 years ago

Sanofi's $20B buyout of Genzyme pays off again with European OK for first Niemann-Pick drug

4 years ago

Flagship's Foghorn, partnered with Merck and Eli Lilly, gets a partial FDA hold after patient death

4 years ago

Proactively preventing shortages: New FDA guidance spells out which drugs require risk management plans

4 years ago

FDA commissioner announces new role for Janet Woodcock, downshifting away from drugs

4 years ago

House committee unanimously advances FDA user fee legislation with accelerated approval tweaks

4 years ago

Senate user fee reauthorization bill omits accelerated approval reforms, shows wide gaps with House version

4 years ago

FDA lobbies Congress over rare disease court ruling with wide implications

4 years ago

Even FDA's Peter Marks is worried about the commercial viability of gene and cell therapies

4 years ago

Pricy inhalers remain expensive due to device tweaks that keep competitors at bay, researchers find

4 years ago

Cytokinetics' long and winding road to develop its lead heart drug will face an adcomm this fall

4 years ago

A CRL later, Gilead clears clinical hold on next-gen HIV drug — after finding a new glass vial for it

4 years ago

Real world evidence: Lessons learned from an FDA pilot show the limits of emulating RCTs

4 years ago

Unpersuaded by the data, FDA rejects cheap, generic SSRI as a Covid-19 drug

4 years ago

Otsuka calls off multibillion-dollar, CKD licensing deal with Akebia in aftermath of CRL

4 years ago

Seeking a come-from-behind win, Eli Lilly lands big approval for next-gen diabetes drug

4 years ago

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