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  • EU regulators back Minoryx’s ALD therapy while rejecting Zevra’s rare-disease drug
    The EU Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Minoryx Therapeutics' drug for adrenoleukodystrophy, marking a significant regulatory step after previous c…
    Endpoints · 29d agoRegulatoryNeutral↗ source
  • Summit Therapeutics faces under a year of cash runway as FDA decision on ivonescimab looms
    Summit Therapeutics reported that its cash and short-term investments total just over $690 million, which the company says is insufficient to fund operations for a full year. The biotech’s lead ca…
    BioSpace · 29d agoRegulatoryNeutral↗ source
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  • Roche drops Carmot’s acmopatide after Phase 2 success, shifts focus to enicepatide for weight loss and diabetes
    Roche announced it will stop developing acmopatide, an investigational obesity treatment acquired from Carmot Therapeutics. Acmopatide had met its primary endpoint in a Phase 2 trial in type 1 dia…
    BioSpace · 29d agoNeutral↗ source
  • Merck launches voluntary licensing for investigational monthly HIV PrEP pill ahead of approval
    Merck has signed voluntary licensing agreements to allow generic manufacturers to produce its investigational monthly HIV PrEP pill, alimatravir, before any regulatory submission. The agreements c…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Sanofi drops pursuit of eczema drug amlitelimab after failed Phase 3 trials
    Sanofi announced it will no longer seek regulatory approval for amlitelimab, an anti‑OX40 ligand antibody intended for atopic dermatitis, after recent Phase 3 data fell short of expectations. The…
    Fierce Biotech · 29d agoRegulatoryNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 29d agoCRLNegative↗ source
  • Sunny Pharmtech voluntarily recalls three lots of cyclophosphamide injection after steel particles found
    Sunny Pharmtech, Inc. announced a voluntary nationwide recall of three lots of cyclophosphamide for injection, USP, in 1‑gram and 2‑gram vials. The recall was triggered by the detection of steel pa…
    fda medwatch · 29d agoCRLNeutral↗ source
  • Scribe Therapeutics launches $129M IPO, kicking off second-half biotech listing spree
    Scribe Therapeutics, a nine-year-old biotech co-founded by CRISPR pioneer Jennifer Doudna, announced its initial public offering. The company priced the IPO at about $128.7 million, raising roughl…
    Endpoints · 29d agoDealPositive↗ source
  • Scribe Therapeutics upsizes IPO to $128.7 million to fund lipid-lowering gene therapy
    Scribe Therapeutics announced pricing its initial public offering at $128.7 million, surpassing the $96 million target it had set earlier in the week. The company sold 8.6 million shares at $15 ea…
    Fierce Biotech · 29d agoDealPositive↗ source
  • Ipsen's Bylvay fails Phase 3 trial in children with biliary atresia
    Ipsen announced that its experimental therapy Bylvay did not meet its primary endpoint in a Phase 3 trial targeting biliary atresia in infants. Biliary atresia is a rare pediatric liver disorder i…
    Endpoints · 29d agoNegative readoutNegative↗ 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 · 29d agoDealNeutral↗ source
  • Sanofi halts development of Kymab-derived OX40L antibody for atopic dermatitis
    Sanofi announced that it will no longer pursue the OX40L antibody program it was developing with Kymab for the treatment of atopic dermatitis. The drug was being positioned as a potential follow‑on…
    Endpoints · 29d agoNegative↗ source
  • Novo Nordisk seeks court order to halt Lilly GLP-1 ads as Merck announces HIV PrEP partnership
    Novo Nordisk asked a New Jersey federal court to temporarily block Eli Lilly's GLP-1 advertisements, claiming the ads are misleading. Merck disclosed that it has entered into a partnership focused…
    Endpoints · 29d agoDealNeutral↗ source
  • Michael Ehlers leaves Ascidian Therapeutics to head R&D at Formation Bio; Black Diamond co-founder passes away at 67
    Michael Ehlers has stepped down as chief executive of Ascidian Therapeutics, the exon‑editing company he co‑founded, to take on the role of head of research and development at Formation Bio, an AI‑…
    Endpoints · 29d agoNeutral↗ source
  • Vaisala senior manager Girish Agarwal receives 1,000 incentive shares
    Vaisala Corporation disclosed that its senior manager Girish Agarwal was granted a share-based incentive. The transaction, reported on July 23, 2026, involved the receipt of 1,000 series A shares…
    globenewswire health · 29d agoNeutral↗ source
  • Vaisala Oyj discloses executive Girish Agarwal receiving 1,000 shares at no cost
    Vaisala Oyj, a Finnish climate‑measurement technology company listed on Nasdaq Helsinki, filed a regulatory notice on 23 July 2026 regarding an insider transaction. The notice identifies Girish Ag…
    globenewswire health · 29d agoRegulatoryNeutral↗ source
  • DSV A/S reports manager share transactions in latest company announcement
    DSV A/S issued Company Announcement No. 1171, informing the market of recent share transactions carried out by a company manager. The disclosure is made under Article 19 of EU Regulation 596/2014,…
    globenewswire health · 29d agoRegulatoryNeutral↗ source
  • Eli Lilly to seek FDA approval for retatrutide in early 2027 after Phase 3 trials show over 20% weight loss
    Eli Lilly said its next‑generation obesity drug retatrutide produced substantial weight loss in two late‑stage Phase 3 studies. The data were presented from the TRIUMPH‑2 and TRIUMPH‑3 trials, whic…
    BioSpace · 1mo agoPositive readoutPositive↗ source
  • Eli Lilly to seek approval next year for retatrutide after strong Phase 3 obesity results
    Eli Lilly announced that its experimental obesity drug retatrutide will be submitted to regulators for approval early next year. The decision follows recent Phase 3 trial data that showed the drug…
    Endpoints · 1mo agoApprovalPositive↗ source
  • Eli Lilly’s retatrutide meets primary goals in phase 3 obesity trials with ~22% weight loss but no clear heart benefit
    Eli Lilly reported that its triple‑hormone agonist retatrutide achieved the primary endpoints in two phase 3 obesity studies, TRIUMPH‑2 and TRIUMPH‑3. The drug was tested at a 12 mg dose against pl…
    Fierce Biotech · 1mo agoPositive readoutNeutral↗ source
  • GSK receives FDA approval for ROS1 inhibitor Jideytro, marking its first lung cancer drug
    GSK's FDA approval of Jideytro, a ROS1 inhibitor for advanced non-small cell lung cancer patients with ROS1 gene fusions who have already received ROS1-directed therapy, was announced on Wednesday.…
    BioSpace · 1mo agoApprovalPositive↗ source
  • FDA advisory panel backs broader use of wellness peptide BPC-157 despite internal concerns
    The FDA advisory committee voted Thursday to recommend loosening restrictions on BPC-157, a peptide popular among health and wellness enthusiasts for muscle repair, injury healing, metabolism suppo…
    Endpoints · 1mo agoRegulatoryPositive↗ source
  • Repligen to acquire BioLife Solutions for $1.5 billion as BeOne announces $300 million US expansion
    Repligen announced it will acquire cell‑processing services provider BioLife Solutions in a transaction valued at roughly $1.5 billion. The deal adds BioLife’s platform to Repligen’s portfolio of b…
    Endpoints · 1mo agoDealNeutral↗ source
  • Scancell to list on Nasdaq after reverse merger with Neuphoria, funds $89M for melanoma immunotherapy trial
    Scancell announced that it will become a publicly traded company on Nasdaq after completing an all‑stock reverse merger with Neophobia Therapeutics. The transaction gives Scancell a new ticker, SCL…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Merck CEO warns Congress that restricting US-China biotech deals could cost America its biotech leadership
    Merck CEO Rob Davis told Congress and the Trump administration that limiting or cutting off US-China dealmaking would jeopardize US biotech leadership. He emphasized that collaboration with Chines…
    Endpoints · 1mo agoRegulatoryNegative↗ source