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Takeda slammed with surprise PhIII failure on 'breakthrough' blood cancer drug, imploding launch plans
4 years ago
R&D
Rulemaking authority restored at FDA as a show of support in a tumultuous time
4 years ago
FDA+
Roche schizophrenia drug that failed PhIII gets a new life in rare disorder as OrbiMed leads $90M for startup
4 years ago
Financing
Startups
AbbVie's stock and next megablockbuster take hits following new JAK warnings from FDA
4 years ago
Pharma
FDA+
FDA warns of heart-related events, cancer, blood clots, and death for JAK inhibitors
4 years ago
FDA+
FDA posed a sprawling set of questions for two-day gene therapy hearing. Here's what companies and experts will be ...
4 years ago
Cell/Gene Tx
FDA+
Ligand Pharma partner wins Chinese approval for anti-PD-1; Brickell receives exclusive rights to DYRK1A inhibitor
4 years ago
News Briefing
After 2 damning CRLs and 3 denied dispute-resolution requests, an ailing, one-time unicorn has only a glimmer of hope ...
4 years ago
R&D
FDA+
Expanding on injectable schizophrenia franchise, J&J secures nod for first twice-yearly treatment
4 years ago
FDA+
An FTC review of the Sanofi/Translate merger has a new deadline after agency calls for more time
4 years ago
Deals
Pharma
With drug pricing reform potentially closer than ever, Public Citizen pens new letter calling for change
4 years ago
Pharma
A Lonza veteran takes the helm of new Swiss CDMO offering manufacturing know-how to startups
4 years ago
Manufacturing
Astellas pauses Audentes' gene therapy program again after 'abnormal' liver tests in yet another setback
4 years ago
R&D
Cell/Gene Tx
A next-gen IL-2 challenger bags a megaround with RA Capital on board to accelerate 'modular' drug platform
4 years ago
Financing
R&D
Opinion: Time for Biden to explain the political meddling in Covid vaccine reviews
4 years ago
FDA+
Covid-19 roundup: Pfizer, Merck start late-stage trials for Covid-19 pills; Merck begins PhIII study on post-exposure ...
4 years ago
Coronavirus
FDA extends full approval for Merck's Keytruda in 1st-line bladder cancer after mixed adcomm vote
4 years ago
Pharma
FDA+
Cautiously optimistic, AC Immune delivers a mixed set of Alzheimer's data — but investors love it
4 years ago
R&D
SR One leads $55M round for nasal alternative to EpiPen; Sanofi pulls website over accuracy concerns
4 years ago
News Briefing
In a major blow to vaccine efforts, senior FDA leaders stepping down
4 years ago
People
FDA+
Antiviral nasal drop maker does the Nasdaq shuffle as part of minor SPAC reverse merger
4 years ago
Financing
Deals
Moving past a patient death, Poseida offers an early snapshot of proof of efficacy for a next-gen solid tumor CAR-T
4 years ago
R&D
Cell/Gene Tx
ARCH-backed George Church spinout shuts down after gene therapy tech struggles in animal models
4 years ago
Startups
A jog down memory lane: How many times have Democrats tried and failed to win drug price negotiations?
4 years ago
Pharma
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