FDA+ channel feed – Endpoints News

FDA+ channel feed

Merck pulls Keytruda in SCLC after accelerated nod. Is the FDA getting tough on drugmakers that don't hit their marks?

5 years ago

Biotech's shares routed after the FDA demands new trial, raises safety and endpoint issues in surprise CRL

5 years ago

BridgeBio spins gold out of an Alexion castoff, scoring an FDA approval in rare metabolism disorder

5 years ago

Feds clear the road for J&J to start delivering millions of doses of their Covid-19 vaccine — but frets linger about runner-up status

5 years ago

Why not? Sarepta’s third Duchenne MD drug sails to accelerated approval

5 years ago

Biden is looking beyond Woodcock or Sharfstein for FDA commissioner — report

5 years ago

FDA reviewers endorse J&J single-dose shot, laying path for 3rd US vaccine

5 years ago

Pfizer gets an FDA fast-pass for an old vaccine with potential military applications

5 years ago

It's official: FDA clamps a hold on bluebird's troubled LentiGlobin program while EMA considers new measures

5 years ago

FDA issues new recommendations to take on Covid-19 variants

5 years ago

Libtayo scores second OK in two weeks, this time for front-line NSCLC. Can it take on Keytruda?

5 years ago

Despite red flag from FDA, controversial ALS cell therapy developer says it may still march ahead anyway

5 years ago

After crossing t's, dotting i's, Immunocore nails down breakthrough therapy designation for lead TCR therapy

5 years ago

Biopharma execs routinely shun revealing the hard truth when it comes to RTFs. And some people at the FDA think that's a big problem

5 years ago

Mallinckrodt becomes the latest victim of the FDA's pandemic-related delays as it pushes off application for skin graft

5 years ago

Janet Woodcock slams calls for FDA 'firewall' amid aducanumab debacle, citing need for collaborative drug development

5 years ago

Weeks after dropping big response data, Amgen lines up priority review for KRAS hopeful sotorasib in NSCLC

5 years ago

Novartis' Entresto, facing a big comeback in hard-to-treat heart failure patients, scores FDA nod after adcomm cakewalk

5 years ago

Sesen Bio, after years on the edge of irrelevancy, scores speedy review for long gestating bladder cancer program

5 years ago

Updated: Cortexyme's unorthodox Alzheimer's approach tripped up by FDA hold

5 years ago

Astellas, Seagen pave the way for Padcev's global rollout with full confirmatory data for urothelial cancer in hand

5 years ago

FDA slaps Florida's Allay Pharmaceuticals with warning letter over vague responses to drug potency issues

5 years ago

Amicus shares slammed as lead PhIII drug fails a key head-to-head test for Pompe disease — but the CEO still projects an FDA OK and bright future

5 years ago

Regeneron antibody earns nod for rare cholesterol disorder — but it ain't cheap

5 years ago

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