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596 stories matching this filter · ← front page

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  • FDA schedules advisory committee meetings for rejected Replimune melanoma drug and Capricor DMD cell therapy
    The FDA announced that it will hold two advisory committee meetings this week to revisit investigational therapies that were previously turned down. One meeting will consider Capricor Therapeutics'…
    BioSpace · 4d agoRegulatoryNeutral↗ source
  • ‘This could be a large market’: Novo Holdings-backed Claris secures $118M for corneal disease drug
    A new biotech has come into view with a $118 million series B and a vision for making the front of the eye front-of-mind.
    Fierce Biotech · 3d agoNeutral↗ source
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  • Apnimed aspires for up to $160M IPO as sleep apnea pill launch nears
    Apnimed has detailed its plans for an initial public offering, with the biotech intending to raise as much as $160 million to fund the launch of its sleep apnea pill.
    Fierce Biotech · 4d agoNeutral↗ source
  • MapLight shares sink on mixed phase 2 schizophrenia readout
    MapLight Therapeutics’ stock plummeted more than 60% this morning after the neuro outfit dropped mixed results for a phase 2 trial of its experimental schizophrenia treatment.
    Fierce Biotech · 4d agoNeutral↗ source
  • Legend Biotech CEO abruptly steps down without permanent replacement
    In a sudden leadership shift, Legend Biotech announced that its CEO, Ying Huang, Ph.D., resigned on Friday, with no permanent replacement yet named.
    Fierce Biotech · 4d agoNeutral↗ source
  • Sanofi scraps most atopic dermatitis trials after amlitelimab fails to outperform standard care
    Sanofi announced it is halting all but one ongoing trial for amlitelimab, an OX40‑ligand antibody acquired through its $1.4 billion purchase of Kymab. The decision follows the Phase 3 COAST‑1 stud…
    BioSpace · 7d agoNegative readoutNegative↗ source
  • Scribe Therapeutics raises $129 million in rare early-stage IPO to fund epigenetic heart disease therapy
    Scribe Therapeutics, founded by Jennifer Doudna, completed an IPO raising nearly $129 million, selling 8.58 million shares at $15 each. It is the first gene‑editing company to go public in more tha…
    BioSpace · 7d agoDealPositive↗ source
  • Amgen seeks FDA hearing to keep rare kidney drug Tavneos amid safety concerns
    Amgen has asked the U.S. Food and Drug Administration for a hearing to argue against a proposed withdrawal of its rare‑disease drug Tavneos. The company submitted a data package containing real‑wo…
    BioSpace · 7d agoRegulatoryNegative↗ source
  • Amgen cuts about 40 jobs, about 0.1% of workforce, amid ongoing challenges
    Amgen announced the layoff of roughly 40 employees, representing about 0.1% of its global staff, as part of organizational changes aimed at aligning operations with strategic objectives. The compan…
    Fierce Biotech · 7d agoLayoffsNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 7d agoNegative↗ source
  • Novo escalates legal fight with Lilly; J&J reinforces ‘dominance’ in multiple myeloma
    Novo is seeking an injunction that would halt allegedly “misleading” obesity drug ads. Elsewhere, the FDA began reviewing a highly anticipated medicine and a veteran investor landed at an AI startup.
    BioPharma Dive · 7d ago↗ source
  • Study of Yescarta patients reveals genetic red flags for CAR-T therapy side effects
    A new analysis of patients who took part in clinical trials for Kite Pharma’s CAR-T cell therapy Yescarta has revealed genetic signatures of toxicity risk, potentially providing a path forward for…
    Fierce Biotech · 7d ago↗ source
  • Lilly’s $3.8B psychedelics bet won’t open the M&A floodgates
    Eli Lilly’s $3.8 billion play for AtaiBeckley has fueled speculation that Big Pharma is ready to embrace psychedelics. But while the acquisition does validate the drug class, analysts say it is unl…
    BioSpace · 7d ago↗ source
  • Summit has less than a year of cash runway left as PD-1/VEGF verdict nears
    Summit’s star asset is the PD-1/VEGF bispecific ivonescimab, which this week produced promising survival data from a late-stage global trial in non-small cell lung cancer. The FDA review is ongoing…
    BioSpace · 7d ago↗ source
  • Roche cans one Carmot obesity asset as another shows best-in-class potential
    Acmopatide met the main goal of a Phase 2 study in type 1 diabetes, but Roche is axing the investigational drug to prioritize enicepatide for weight loss, type 2 diabetes and cardiovascular outcome…
    BioSpace · 7d ago↗ source
  • Merck stages expanded access to monthly HIV PrEP pill ahead of approval
    Following in the footsteps of Gilead, Merck has signed voluntary licensing agreements to enable access to its investigational HIV PrEP pill alimatravir ahead of any regulatory submissions.
    Fierce Biotech · 7d ago↗ source
  • Sanofi abandons plan to seek approval for eczema drug from $1.1B Kymab buyout
    Sanofi has abandoned plans to seek approval for amlitelimab in atopic dermatitis, admitting that a drug once tipped as a potential blockbuster “would not represent a meaningful improvement” to exis…
    Fierce Biotech · 7d ago↗ source
  • Scribe secures $129M in a rare gene editing IPO
    The startup is the first gene editing company to price an IPO in more than two years, though it banked far less than most other biotechs that have gone public in 2026.
    BioPharma Dive · 7d ago↗ source
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 7d ago↗ 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 · 7d ago↗ source
  • Update: FDA does not freeze CRL trove as ‘radical transparency’ push hits speedbump
    An unnamed pharma filed a citizen petition in April seeking reforms to the way the FDA publicly releases rejection letters, alleging that the policy “contravenes decades of agency practice.”
    BioSpace · 7d ago↗ source
  • Chutes & Ladders—Biogen R&D vet gets in Formation
    AI-focused Formation Bio has found a new chief scientist with extensive experience in biotech, Big Pharma and academia. Michael Ehlers, M.D., Ph.D., is joining the 2025 Fierce 15 honoree as chief s…
    Fierce Biotech · 7d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 8d ago↗ source
  • From Abu Dhabi to Brazil, every region is vying for the ‘new emerging economy’ of biotech
    Whether it's looming tariff threats or the rise of China, you need a truly global view to navigate today's biopharma industry.
    Fierce Biotech · 8d ago↗ source
  • BeOne commits $300M to US manufacturing expansion, creating 120 new jobs
    The addition of small molecule capacity at BeOne Medicines’ Hopewell site will support the company’s hematology efforts and bring total investment in the campus to more than $1 billion.
    BioSpace · 8d ago↗ source