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579 stories matching this filter · ← front page

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  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 7d agoApprovalPositive↗ source
  • FDA launches Rare Disease Framework Initiative to reshape drug development for small patient populations
    The FDA announced a new Rare Disease Framework Initiative aimed at overhauling how drugs and biologics for rare conditions are developed. The initiative will produce a tailored framework that refl…
    fda press · 7d agoRegulatoryPositive↗ source
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  • UK regulator MHRA unveils multi-year plan to speed AI-driven drug oversight
    The UK Medicines and Healthcare products Regulatory Agency (MHRA) has released a multi-year strategy aimed at keeping its regulatory framework patient-focused as artificial intelligence and persona…
    raps · 8d agoRegulatoryNeutral↗ source
  • BD and CareFusion recall Alaris Pump infusion sets due to serious performance risks
    The FDA has classified the recall of BD Alaris Pump infusion sets as the most serious type, warning that continued use could cause serious injury or death. BD and its subsidiary CareFusion sent an…
    fda medwatch · 8d agoCRLNegative↗ source
  • Convenience Kit Recall: AVID Medical Removes Convenience Kits Affected by BD ChloraPrep Applicator Recall
    Avid Medical is removing certain convenience kits affected by the BD ChloraPrep Applicator Recall that may be contaminated with Aspergillus penicillioides.
    fda medwatch · 8d ago↗ source
  • Study urges regulators to adopt cloud platforms to speed drug approvals
    A new study led by Nina Cauchon of Amgen and co-authors, published in the Journal of Pharmaceutical Sciences, calls for broader use of cloud-based platforms by regulatory agencies. The authors arg…
    raps · 9d agoRegulatoryPositive↗ source
  • Medline pulls convenience kits containing recalled BD ChloraPrep applicators due to contamination risk
    Medline has advised that certain convenience kits it distributes must be removed from use and destroyed because they contain BD ChloraPrep applicators that are subject to a recall over possible fun…
    fda medwatch · 9d agoCRLNegative↗ source
  • Stakeholders urge FDA to adopt flexible approach for psychedelic drug regulation
    Various individuals and groups have submitted comments urging the U.S. Food and Drug Administration to be flexible in regulating psychedelic medicines that could treat major depressive disorder and…
    raps · 9d agoRegulatoryNeutral↗ source
  • Roche signs $1.2B partnership with China’s Rona for obesity drug as Stryker pours $400M into CMR Surgical
    Roche has entered a $1.2 billion agreement with Chinese firm Rona to advance an obesity treatment, targeting the growing market for weight‑loss therapies in China. The deal will combine Roche’s dr…
    raps · 9d agoDealPositive↗ source
  • FDA approves new treatments for persistent herpes and schizophrenia; Steris to acquire Xodus Medical for $2.1 billion
    The U.S. Food and Drug Administration has granted approvals for two new drugs, one targeting persistent herpes infections and another for the treatment of schizophrenia. The herpes indication addr…
    raps · 10d agoApprovalPositive↗ source
  • FDA finalizes guidance aligning biosimilar post-approval manufacturing changes with global standards
    The U.S. Food and Drug Administration has issued its final guidance on how biosimilar manufacturers can implement post-approval changes to their production processes. The new recommendations bring…
    raps · 10d agoRegulatoryNeutral↗ source
  • Japan's PMDA Issues Guidance to Safeguard Participants in Generic Bioequivalence Trials
    The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan has released new guidance aimed at protecting healthy adult volunteers who take part in generic bioequivalence studies. The document…
    raps · 10d agoRegulatoryNeutral↗ source
  • Europe’s share of clinical trials falls 13.5% as Asia’s research footprint expands
    The latest data show a 13.5% drop in the number of clinical trials authorized in the EU and EEA compared with pre-pandemic levels. At the same time, Asian countries have increased their share of g…
    raps · 10d agoNeutral↗ source
  • FDA week: HHS launches vaccine injury study, midterms may reshape oversight committees, and patent thickets threaten generics
    The Department of Health and Human Services announced a new agency‑wide effort to examine and address injuries that may be linked to vaccines. The initiative will coordinate research across FDA and…
    raps · 13d agoRegulatoryNeutral↗ source
  • Study finds rising patent thickets may slow generic drug competition
    A recent special communication in JAMA reports that the number of patents linked to FDA‑approved small‑molecule drugs has risen over the past 15 years. The increase is driven largely by non‑primary…
    raps · 13d agoNeutral↗ source
  • FDA issues early alert on Philips Lumify ultrasound system software and connection problems
    The FDA’s Center for Devices and Radiological Health has released an Early Alert about a potential high‑risk issue with Philips Lumify diagnostic ultrasound devices. The problem involves either a s…
    fda medwatch · 13d agoRegulatoryNegative↗ source
  • FDA unveils transparency roadmap with plans for public NDA/BLA disclosures and inspection report publishing
    The FDA published a transparency roadmap that outlines its FY 2026 achievements and sets out priorities for FY 2027. One key priority is a proposal to require public disclosure of new drug applica…
    raps · 14d agoRegulatoryNeutral↗ source
  • EU Commission urges EMA to fast-track Biotech Act preparations
    The European Commission has issued a statement urging the European Medicines Agency to accelerate work on the upcoming Biotech Act, which aims to streamline regulation of advanced therapies. The C…
    raps · 14d agoRegulatoryNeutral↗ source
  • Recon: FDA identifies four deaths in Newron schizophrenia drug trials; Dutch court blocks subcutaneous Keytruda in eight Europea...
    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
    raps · 14d ago↗ source
  • EMA to revise pharmacogenomics guideline as MHRA adopts AI framework for medical devices
    The European Medicines Agency’s Committee for Medicinal Products for Human Use is preparing a major revision of its 2018 guideline on good pharmacogenomic practices. Regulators say the rapid advan…
    raps · 15d agoRegulatoryNeutral↗ source
  • UK regulator adopts AI framework for medical devices and launches third AI Airlock phase
    The Medicines and Healthcare products Regulatory Agency (MHRA) announced that the UK government has adopted a set of recommendations on the use of artificial intelligence in medical devices. These…
    raps · 16d agoRegulatoryNeutral↗ source
  • UK regulator adopts AI framework for medical devices, launches next phase of AI sandbox
    The Medicines and Healthcare products Regulatory Agency announced that the UK government has accepted a set of recommendations on using artificial intelligence in medical devices. These recommendat…
    raps · 16d agoRegulatoryPositive↗ source
  • WHO releases updated draft guideline to strengthen quality risk management for manufacturers and regulators
    The World Health Organization has issued an updated draft guideline designed to help manufacturers establish effective quality risk management systems and to aid regulators in planning inspections.…
    raps · 16d agoRegulatoryNeutral↗ source
  • FDA warns Evolus over misleading Instagram claims about Jeuveau
    The FDA's Office of Prescription Drug Promotion sent an untitled warning letter to Evolus, the maker of the injectable cosmetic product Jeuveau. The letter says the company exaggerated the drug’s…
    raps · 17d agoRegulatoryNegative↗ source
  • Bayer to invest $2.2B in new Ohio manufacturing complex as FDA CDER opens clinical trial modernization office
    Bayer announced plans to spend roughly $2.2 billion on a new manufacturing site in Ohio, aiming to broaden its production capabilities. The investment is projected to increase capacity and generat…
    raps · 17d agoRegulatoryNeutral↗ source