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37 stories matching this filter · ← front page

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  • Leo Pharma to acquire experimental rare-skin disease drug dersimelagon in up to $435 million deal
    Leo Pharma announced it will acquire the rights to dersimelagon, an experimental oral therapy currently under FDA review, in a transaction that could total up to $435 million in upfront and near‑te…
    BioPharma Dive · 2d agoDealNeutral↗ source
  • Slate Medicines to merge with Fulcrum Therapeutics after Fulcrum drops sickle-cell drug
    Slate Medicines announced it will combine with Fulcrum Therapeutics in a reverse merger, giving the struggling biotech a new corporate home. Fulcrum had been developing pociredir, a therapy design…
    BioPharma Dive · 3d agoDealNegative↗ source
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fda recalls47
fda medwatch36
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Psychiatry & CNS712
Ophthalmology420
Endocrinology & Metabolism380
Pain372
Infectious Disease353
  • Latigo Biotherapeutics raises $345.6M in IPO to fund non-opioid pain drug pipeline
    Latigo Biotherapeutics, a Los Angeles-based biotech focused on non-opioid ion-channel-blocking pain therapies, completed an initial public offering on Thursday. The company sold 19.2 million share…
    BioPharma Dive · 13d agoDealPositive↗ source
  • FDA approves Moderna's first mRNA flu vaccine for adults 50 and older
    The Food and Drug Administration has granted approval to Moderna's mRNA flu vaccine, called mFlusiva and previously known as mRNA-1010, making it the first preventive flu shot built on messenger RN…
    BioPharma Dive · 14d agoApprovalPositive↗ source
  • Cardiac biotech Braveheart raises $382.5M in IPO, launches on Nasdaq as BRVE
    Braveheart Bio, a cardiac drug developer, priced its initial public offering on Wednesday and secured $382.5 million in proceeds. The company sold about 21.2 million shares at $18 each, exceeding t…
    BioPharma Dive · 14d agoDealPositive↗ source
  • 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 · 21d agoNegative readoutNegative↗ source
  • Claris Bio raises $118M Series B and appoints new CEO to advance eye-drug for limbal stem cell deficiency
    Claris Bio, a New Jersey biotechnology company, announced a $118 million Series B financing round co-led by Samsara BioCapital and Catalio Capital Management, with participation from Sofinnova Inve…
    BioPharma Dive · 23d agoDealPositive↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 23d agoDealNeutral↗ source
  • MapLight shares plunge 66% after mid-stage schizophrenia trial shows modest benefit but raises competitive concerns
    MapLight Therapeutics announced results from its mid‑stage trial of an experimental schizophrenia drug. The study enrolled adults experiencing an acute exacerbation of psychotic symptoms. The twic…
    BioPharma Dive · 24d agoPositive readoutNegative↗ source
  • FDA advisory panel votes to expand use of four untested peptides despite safety concerns
    An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The…
    BioPharma Dive · 27d agoRegulatoryNegative↗ source
  • Crystalys Therapeutics raises $130M Series B to advance gout drug dotinurad toward global launch
    Crystalys Therapeutics announced a $130 million Series B financing to move its gout drug dotinurad through late-stage trials and prepare for commercial launch. The round was led by Frazier Life Sc…
    BioPharma Dive · 29d agoDealPositive↗ source
  • Latigo Biotherapeutics Announces Plans for Nasdaq IPO to Fund Non-Opioid Pain Drug Development
    Latigo Biotherapeutics, a Westlake BioPartners spin‑out founded in 2018, said it will seek a Nasdaq listing under the ticker LTGO. The company develops non‑opioid analgesics that block sodium ion…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • GSK drops camlipant cough drug after mixed Phase 3 results
    GSK announced it is halting development of camlipant, an experimental chronic cough medicine it acquired in a $2 billion purchase three years ago. The decision follows two Phase 3 trials that show…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 1mo ago↗ source
  • Viridian may have edge over Amgen in eye drug showdown, analysts argue
    The FDA, through a new approval, gave Viridian's drug a label that some on Wall Street believe makes it well-positioned to compete against Tepezza in the thyroid eye disease market.
    BioPharma Dive · 1mo ago↗ source
  • 10 clinical trials to watch in the second half of 2026
    The biotechnology sector’s upswing accelerated in the first half. Positive results from anticipated trials in lung cancer, Alzheimer’s and multiple autoimmune conditions could add to the momentum.
    BioPharma Dive · 1mo ago↗ source
  • Moderna flu vaccine wins unanimous support from FDA panel
    The endorsement of an advisory committee positions Moderna to complete a dramatic turnaround for a shot the FDA declined to review earlier this year.
    BioPharma Dive · 2mo ago↗ source
  • A new Westlake-backed biotech takes aim at migraines
    Vedana Therapeutics emerged from stealth Wednesday with $46 million to support its mission of developing “anti-PACAP” therapies, an increasingly popular strategy for migraine prevention.
    BioPharma Dive · 2mo ago↗ source
  • Lilly buys non-opioid pain drugmaker 4E
    It’s the latest in a string of deals for Lilly, which has sunk more than $18 billion into acquisitions over the past few years.
    BioPharma Dive · 2mo ago↗ source
  • Lilly scores early positive data for new JAK drug
    Acquired through its purchase of Ajax, the drug showed encouraging effects in patients with hard-to-treat myelofibrosis. To analysts, such results could lead to competition for Incyte’s Jakafi.
    BioPharma Dive · 2mo ago↗ source
  • Celiac disease is entering a new era of therapeutic innovation
    For the ~1 in 100 people living with celiac, the burden of disease extends far beyond their plate.
    BioPharma Dive · 2mo ago↗ source
  • Rapport ‘fully prepared’ to launch seizure drug solo, CEO says
    In a wide-ranging interview, Abe Ceesay detailed how Rapport built an investor syndicate and why the company is confident it can join the ranks of successful, commercial-stage brain drugmakers.
    BioPharma Dive · 2mo ago↗ source
  • Study data convince Lundbeck to push new migraine drug forward
    A possible alternative to “anti-CGRP” medications, the drug didn’t meet some analysts’ expectations in mid-stage testing but still convinced Lundbeck to pursue further development.
    BioPharma Dive · 2mo ago↗ source
  • Legend surges on early data for ‘in vivo’ lymphoma cell therapy
    Initial findings show that the therapy reduced or eliminated disease signs in all recipients, sparking hopes that the treatment might be competitive with “ex vivo” medicines like Novartis’ Kymriah.
    BioPharma Dive · 2mo ago↗ source