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378 stories matching this filter · ← front page

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  • 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 · 27d agoRegulatoryNegative↗ 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 · 27d agoDealPositive↗ source
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Infectious Disease356
  • 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 · 27d 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 · 27d agoRegulatoryNeutral↗ 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 · 27d 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 · 27d 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 · 27d agoRegulatoryNeutral↗ 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 · 28d agoPositive readoutNeutral↗ 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 · 28d agoDealPositive↗ 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 · 28d agoRegulatoryNeutral↗ source
  • Biotech hubs from Abu Dhabi to Brazil compete to become the next emerging economy
    Fierce reporters attended the Biotechnology Innovation Organization conference in San Diego to gauge how biotech hubs worldwide are positioning themselves amid tariff concerns and China’s growing i…
    Fierce Biotech · 28d agoNeutral↗ source
  • Roche halts lupus T-cell engager RG6382 development after early trial review
    Roche announced it is stopping work on RG6382, a bispecific T-cell engager targeting CD19 and CD3, which was being tested in a phase‑1 study in patients with systemic lupus erythematosus (SLE). Th…
    Fierce Biotech · 28d agoNegative↗ source
  • FDA approves Johnson & Johnson's Ottava robotic system for multiple soft-tissue surgeries
    FDA cleared Johnson & Johnson's Ottava robotic surgical system, marking its entry into the market. The clearance covers a range of soft-tissue procedures such as gastric bypass, gastrectomy, chole…
    Fierce Biotech · 28d agoApprovalPositive↗ source
  • Roche Diagnostics sales rise only 3% in H1 2026 as China pricing reforms weigh
    Roche Diagnostics reported sales of 6.73 billion Swiss francs for the first half of 2026, a 3% increase at constant exchange rates but a 3% decline in reported franc terms. Growth was limited by p…
    Fierce Biotech · 28d agoEarningsNegative↗ source
  • Clinuvel to relocate HQ to US and cut up to 20% of staff
    Clinuvel Pharmaceuticals, an Australian biotech, announced it will move its corporate headquarters to the United States starting Jan 1, 2027. The company said the shift is aimed at attracting U.S.…
    Fierce Biotech · 28d agoLayoffsNegative↗ 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 · 28d agoRegulatoryNeutral↗ source
  • EMA seeks input on draft revisions to biosimilar efficacy guidance
    The European Medicines Agency has issued a draft concept paper and is asking stakeholders for feedback on proposed revisions to its guideline for biosimilar efficacy studies. The changes are inten…
    raps · 28d agoRegulatoryNeutral↗ source
  • FDA advisory panel votes to add two peptides, BPC-157 and KPV, to 503A bulk compounding list
    The FDA’s advisory committee voted 8-6, with one abstention, to recommend that two peptides be placed on the 503A Bulks List for bulk compounding. The recommendation covers BPC-157, proposed for ul…
    raps · 28d agoRegulatoryNeutral↗ source
  • Formation Bio appoints veteran biotech leader Michael Ehlers as chief scientific officer
    Formation Bio, an AI-focused biotech, announced the hiring of Michael Ehlers, M.D., Ph.D., as its chief scientific officer and head of research and development. Ehlers brings a blend of academic a…
    Fierce Biotech · 28d agoPositive↗ source
  • Chairman of Urbo Bank purchases €25,000 of bank's subordinated bonds
    Urbo bankas UAB disclosed that its Chairman of the Board, Marius Arlauskas, acquired the bank's subordinated bonds. The acquisition covered 25 bonds with a total consideration of EUR 25,000 and wa…
    globenewswire health · 28d agoRegulatoryNeutral↗ source
  • Alm. Brand A/S discloses executive share transactions per EU regulation
    Alm. Brand A/S has issued a regulatory filing that details recent trading activity in its own shares by company executives and their related parties. The disclosure is made under Article 19 of EU…
    globenewswire health · 28d agoRegulatoryNeutral↗ source
  • Urbo Bank discloses board chair’s purchase of 25 subordinated bonds for €25,000
    Urbo Bank announced that its board chairman and administration head, Marius Arlauskas, bought 25 units of the bank’s subordinated bonds (ISIN LT0000135659). The purchase, amounting to €25,000, was…
    globenewswire health · 28d agoDealNeutral↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 29d agoRegulatoryPositive↗ source
  • NIH joins Trump’s $5B AI Genesis Mission to boost biomedical research
    The U.S. Department of Health and Human Services announced that the National Institutes of Health will take part in the President’s Genesis Mission, a $5 billion AI-driven effort. The initiative a…
    Fierce Biotech · 29d agoRegulatoryPositive↗ source
  • House passes FDA Modernization Act 3.0 to push update of animal testing regulations
    The U.S. House approved the FDA Modernization Act 3.0, a bill aimed at modernizing preclinical testing rules. The legislation requires the FDA to revise regulations that still reference animal tes…
    Fierce Biotech · 29d agoRegulatoryPositive↗ source