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356 stories matching this filter · ← front page

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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
  • 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
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  • 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
  • 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
  • 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
  • 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
  • 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 · 22d 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 · 22d agoRegulatoryNeutral↗ 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 · 22d 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 · 22d 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 · 22d 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 · 23d agoRegulatoryPositive↗ source
  • FDA sends warning letters to Sanofi and Viatris over misleading product claims
    The FDA’s Office of Prescription Drug Promotion issued untitled warning letters to Sanofi and Viatris after reviewing promotional materials that the agency deemed misleading. The letters cite spec…
    raps · 23d agoRegulatoryNegative↗ source
  • MDCG: Only manufacturers should assign UDI-DIs
    The European Commission's Medical Device Coordination Group (MDCG) says unique device identifiers and device identifiers (UDI-DI) codes used between manufacturers and distributors need to be better…
    raps · 23d agoNeutral↗ source
  • FDA revokes Orange B color additive and proposes to drop Citrus Red No. 2 from food approvals
    The U.S. Food and Drug Administration issued a final order that revokes the authorized use of Orange B as a food color additive. The agency also proposed revoking Citrus Red No. 2, a pigment autho…
    fda press · 23d agoRegulatoryNeutral↗ source
  • FDA issues warning letters for CGMP breaches and inadequate trial consent, EU releases AI transparency guidelines
    The U.S. Food and Drug Administration sent warning letters to several drug manufacturers for not meeting current good manufacturing practice requirements. One firm was also cited for failing to pr…
    raps · 24d agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, impacting healthcare AI developers
    The European Commission published new guidelines on Monday to help providers and deployers of AI systems meet the transparency obligations set out in the EU AI Act. The guidance includes examples…
    raps · 24d agoRegulatoryNeutral↗ source
  • EU releases AI Act transparency guidelines, affecting health-tech developers
    The European Commission has published new guidelines to help providers and users of artificial intelligence systems meet the transparency obligations set out in the EU AI Act. The document explain…
    raps · 24d agoRegulatoryNeutral↗ source
  • Baxter alerts users to potential air bubble risk in Duo-Vent IV solution sets
    The FDA’s Center for Devices and Radiological Health has issued an early alert about a possible high-risk issue with Baxter’s Duo-Vent intravenous solution sets. The devices may contain air bubbles…
    fda medwatch · 25d agoRegulatoryNegative↗ source
  • UK regulator reports rise in drug approvals and new AI healthcare regulations
    The UK's Medicines and Healthcare products Regulatory Agency (MHRA) released its 2025-2026 annual report to Parliament. The agency highlighted that it approved more new medicines in the past year…
    raps · 25d agoRegulatoryPositive↗ source
  • Study finds China approved more cancer drugs than US between 2020-2025, but US led in first-in-class and speed
    A new analysis published in Health Affairs compares oncology drug approvals by China’s National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) from 2020 thro…
    raps · 25d agoRegulatoryNeutral↗ source
  • UK regulator reports rise in drug approvals and steps to regulate AI in healthcare
    The Medicines and Healthcare products Regulatory Agency (MHRA) presented its 2025-2026 annual report to Parliament, highlighting a higher number of new drug approvals compared with the previous yea…
    raps · 25d agoRegulatoryPositive↗ source
  • Unique Pharma recalls 5 mg cetirizine tablets over possible ranitidine contamination
    Unique Pharmaceutical Laboratories, a division of J.B. Chemicals & Pharmaceuticals Ltd., announced a voluntary nationwide recall of four lots of its 5 mg cetirizine hydrochloride tablets. The reca…
    fda medwatch · 25d agoCRLNegative↗ source