FDA+ channel feed – Endpoints News

FDA+ channel feed

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

3 years ago

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

3 years ago

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

3 years ago

FDA lobbies Congress over rare disease court ruling with wide implications

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

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

3 years ago

Quashing blockbuster hopes, FDA spurns UCB’s IL-17 drug for plaque psoriasis

3 years ago

FDA approves oral formulation of old ALS drug, giving patients new treatment option in sorely needed field

3 years ago

Indian manufacturer hit with Form 483 — again

4 years ago

FDA user fee reauthorizations turn into rare bipartisan lovefest at House hearing

4 years ago

FDA hits Amicus with delay on 'breakthrough' Pompe drug

4 years ago

Biogen pivots to second amyloid-targeted Alzheimer's drug with accelerated approval filing from partner Eisai

4 years ago

Months later, LogicBio exits FDA clinical hold for gene editing drug but won't restart trial until next quarter

4 years ago

FDA's Peter Marks to Congress: Youngest kids vaccine won't need to hit 50% efficacy mark

4 years ago

That big R&D PARP win Clovis CEO Mahaffy touted a few weeks ago? The FDA isn't buying it

4 years ago

FDA and its research take aim at thyroid association's guideline on not using levothyroxine generics

4 years ago

Over 10 years later, FDA officially pulls a BMS accelerated approval, and a Teva copycat falls with it

4 years ago

SEC shines regulatory spotlight on I-Mab, Sinovac and others as more Chinese biotechs scramble to comply with new law

4 years ago

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