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9 stories matching this filter · ← front page

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  • MapLight Therapeutics' mid-stage schizophrenia trial shows modest improvement but shares plunge two-thirds
    MapLight Therapeutics announced that its experimental schizophrenia drug met its primary endpoint in a mid-stage study, delivering an average 4.5‑point reduction on the PANSS symptom scale after fi…
    BioPharma Dive · 1d agoNegative readoutNegative↗ source
  • An eye drug biotech banks $118M and stocks its executive suite
    Claris Bio has appointed veteran CEO Stephen Brady to lead advanced development of what it hopes to be the first drug therapy for a blinding condition called limbal stem cell deficiency.
    BioPharma Dive · 2d agoRegulatoryNeutral↗ source
28
fda recalls22
fda press21
fda medwatch17
178
Vaccines163
Pain106
Ophthalmology103
Endocrinology & Metabolism94
Nephrology71
  • MapLight dives despite positive data for schizophrenia drug
    Shares fell more than 66% Monday morning, which analysts suspect is due to investors seeing the data as not competitive with Bristol Myers' Cobenfy.
    BioPharma Dive · 3d agoRegulatoryNeutral↗ source
  • FDA panel endorses broader use of certain peptides
    In a victory for Robert F. Kennedy Jr.’s “MAHA” agenda, panelists narrowly recommended broader use of six of the seven peptides up for consideration despite a lack of substantive evidence supportin…
    BioPharma Dive · 6d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 8d ago↗ source
  • Pain drugmaker Latigo outlines plans to go public
    The Westlake-founded company specializes in non-opioid drugs that target sodium ion channels, and is now adding to what’s already been a busy month for the biotech IPO queue.
    BioPharma Dive · 10d ago↗ source
  • GSK shelves cough drug acquired in $2B deal
    Mixed Phase 3 data for camlipixant prompted the British pharma to cease development, making the drug the third from its class to fail.
    BioPharma Dive · 13d ago↗ source
  • ARPA-H puts $160M into bespoke drug therapies; Biohaven switches up scientific leadership
    The ARPA-H program could provide researchers with a roadmap to develop personalized gene editing drugs. Elsewhere, a Botox rival succeeded against migraines and two deals were struck.
    BioPharma Dive · 20d ago↗ source
  • FDA approves Regeneron’s hearing loss gene therapy
    Otarmeni, now cleared to treat a rare, inherited kind of hearing loss, is the first gene therapy cleared under the FDA’s “national priority” voucher program and will be offered to eligible patients…
    BioPharma Dive · 3mo ago↗ source