FDA+ channel feed – Endpoints News

FDA+ channel feed

Incyte yanks EU application for PD-1 drug, citing inability to answer regulators' 'major concerns'

4 years ago

FDA's vaccine adcomm unanimously supports Moderna's booster in same populations as Pfizer's booster

4 years ago

Biden likely to nominate Verily's Rob Califf to lead the FDA again

4 years ago

Merck carves out path in first-line advanced cervical cancer with new FDA win for Keytruda juggernaut

4 years ago

Eli Lilly bags FDA nod for Verzenio in early breast cancer, but a controversial diagnostic could dog its rollout

4 years ago

J&J proposes sliding booster timelines as FDA questions lack of data for Delta, older adults before adcomm

4 years ago

FDA authorizes sale of e-cigarettes for the first time, shifting debate and drawing fire from critics

4 years ago

In quick turnaround, FDA lifts full clinical hold on Protagonist's blood cancer program

4 years ago

After three decades and a surprise rejection, first treatment for babies born without a thymus secures FDA approval

4 years ago

The FDA adds a failed Alzheimer's drug to the 'breakthrough' club now looking for a near-term OK

4 years ago

After skepticism and tight vote at adcomm, FDA approves ChemoCentryx's rare disease drug

4 years ago

Newly revealed texts from ex-FDA leader Stephen Hahn offer behind-the-scene glimpse into Trump’s Covid scare

4 years ago

FDA's antimicrobial adcomm unanimously backs Takeda's drug for post-transplant cytomegalovirus

4 years ago

Allogene hit with FDA clinical hold after a patient experiences 'abnormality' in CAR-T cells — shares hammered

4 years ago

Biden's choice for FDA may be a wild card as top candidate says she's not in the running

4 years ago

FDA+ roundup: Sen. Burr on strengthening FDA's readiness; ICH guideline adoption; Longtime FDA lawyer retires and more

4 years ago

FDA offers support for Takeda's potential cytomegalovirus drug ahead of adcomm

4 years ago

FDA center directors on lessons from the EUA pathway: Flexibility serves us well

4 years ago

Gilead and Kite nab another approval for Tecartus, as leading CAR-T portfolio continues to grow

4 years ago

An FDA mistake signals likely approval for first therapy for children born without a thymus

4 years ago

Omeros stock craters as FDA cites deficiencies in application for HSCT-TMA drug

4 years ago

Catalyst wins reversal in orphan exclusivity court battle with FDA

4 years ago

AbbVie, industry group push for international compromise on when trial investigators should receive unblinded data

4 years ago

FDA's top vaccine leader explains why Covid-19 'boosters' may really just be the 3rd shot in the primary series

4 years ago

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