FDA+ channel feed – Endpoints News

FDA+ channel feed

FDA inspection backlog tops 1,000 — and could last for years — as House hearing raises serious concerns

5 years ago

Novartis sues FDA over its stance on Sanofi blockbuster’s exclusivity

5 years ago

CRL on the way? Acadia reports a surprise hitch in its quest to expand the market for Nuplazid — shares routed

5 years ago

Stimulus bill packs a windfall for FDA and Covid-19 drug, vaccine developers

5 years ago

Gilead's Kite keeps adding to CAR-T Yescarta's bag of tricks with FDA approval in follicular lymphoma — a first

5 years ago

Roche withdraws Tecentriq in bladder cancer amid FDA's sweeping review on accelerated approvals

5 years ago

Focusing on the bright side, FDA OKs Roche's Actemra for rare lung disease despite PhIII flop

5 years ago

Pfizer's Xalkori follow-up, which smoked the older drug in 1st-line patients, scores double win at the FDA

5 years ago

As BrainStorm continues to tout ‘clear signal’ on ALS drug, the FDA offers a rare public slapdown on the data

5 years ago

United axes PAH program Trevyent, once bought for cheap in acquisition of a rival, after FDA feedback

5 years ago

FibroGen shares skid lower as a surprise adcomm raises risks on roxa OK

5 years ago

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

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