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1,064 stories matching this filter · ← front page

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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 · 21d agoRegulatoryNeutral↗ 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 · 21d agoCRLNegative↗ source
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  • 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 · 21d 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 · 21d agoDealPositive↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 21d agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 21d agoRegulatoryNeutral↗ 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 · 20d agoNegative readoutNegative↗ 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d 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 · 21d agoRegulatoryNeutral↗ 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 · 22d 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 · 21d 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 · 22d agoDealNeutral↗ source
  • Most FDA-approved drugs meet postmarketing study requirements, and advisory panel backs two peptides for bulk compounding
    A recent analysis published in JAMA Network Open found that nearly nine out of ten drugs approved by the U.S. Food and Drug Administration have completed their postmarketing requirements or commitm…
    raps · 22d agoRegulatoryNeutral↗ 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 · 22d agoRegulatoryNegative↗ source
  • Scancell to merge into Neuphoria and seek $89 million equity as AstraZeneca's breast cancer drug gains EU approval
    Scancell announced it will merge into Neuphoria Therapeutics, taking over Neuphoria's Nasdaq listing ($NEUP) and planning to change the ticker to SCLT. The combined entity aims to raise up to $89 m…
    Endpoints · 22d agoDealPositive↗ source
  • Biogen looks to Apellis acquisition to boost lagging Leqembi sales
    Biogen CEO Chris Viehbacher said the company's Alzheimer's drug Leqembi has underperformed since its 2023 launch. The drug, co-developed with Eisai, has struggled to meet sales expectations, promp…
    Endpoints · 22d agoDealNeutral↗ source
  • Medicare proposal threatens funding for remote patient monitoring programs
    Medicare announced a proposal to sharply reduce reimbursement for remote patient monitoring services, reversing earlier policy support. The change would cut payments to firms that supply technolog…
    Endpoints · 22d agoRegulatoryNegative↗ source
  • Roche stresses careful AI token use and pauses drug from Carmot acquisition
    Roche's CEO Thomas Schinecker said the company is adopting a thoughtful approach to how it employs AI tokens, emphasizing responsible use. He noted that AI tools have already helped increase the n…
    Endpoints · 22d agoNeutral↗ source
  • Verdiva Bio appoints former Metsera CMO Steve Marso as it nears key obesity pill readouts
    Verdiva Bio, a developer of a long-acting oral obesity treatment, announced the appointment of Steve Marso as its chief medical officer. Marso joins from Metsera, a biotech that pursued similar GL…
    Endpoints · 22d agoNeutral↗ source
  • Teladoc expands beyond single-visit model with new service launch
    Teladoc, a pioneer in virtual care, originally built its platform around brief, one-time doctor appointments that could be completed without an in-person visit. The company now says that this sing…
    Endpoints · 22d agoPositive↗ source
  • J&J gets FDA clearance for general surgery robot; study finds 90% of approved drugs meet post-marketing commitments
    J&J received FDA authorization for a general‑surgery robot, a notable regulatory step for the company. The FDA is also being urged to ban direct‑to‑consumer drug advertisements, highlighting ongoi…
    raps · 22d agoRegulatoryNeutral↗ source