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  • Singapore moves forward with legislation for a more coherent, future-ready healthcare regulatory system
    Singapore's Parliament has taken a step toward overhauling its healthcare regulatory framework by advancing new legislation. The proposed law aims to create a more coherent and future-ready system…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA says regulators pledge API inspection sharing but report modest progress
    The European Medicines Agency reports that regulators worldwide are strongly committed to sharing plans for good manufacturing practice inspections of active pharmaceutical ingredient suppliers. D…
    raps · 1mo agoRegulatoryNeutral↗ source
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  • RAPS Convergence 2026 Highlights Future of Regulatory Science and Patient Safety
    The RAPS Convergence 2026 event gathered regulatory professionals to reflect on how the field has changed. Attendees discussed how emerging technologies are reshaping regulatory processes and expe…
    raps · 1mo agoRegulatoryPositive↗ source
  • EMA issues new guideline on assessing gastrointestinal drug interaction risks
    The European Medicines Agency has released a guideline that outlines how to evaluate drug interactions that occur in the gastrointestinal (GI) tract. The document focuses on extrinsic factors such…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Wakefern recalls select organic unsweetened apple sauce jars over high patulin levels
    Wakefern Food Corp announced a voluntary recall of certain containers of its Wholesome Pantry Organic Unsweetened Apple Sauce after FDA testing found patulin levels above safety limits. Patulin is…
    fda recalls · 1mo agoCRLNegative↗ source
  • A&P Creations LLC Issues Nationwide Recall of biQ-FEL Due to Undeclared Sildenafil and Tadalafil
    Sildenafil and Tadalafil are active ingredients in FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. FDA approval of Viagra and Cialis is restrict…
    fda recalls · 1mo ago↗ source
  • Centric Compounding recalls Glutathione, Myer’s Cocktail and Tri-Immune Boost injectables over elevated endotoxin levels
    Centric Compounding LLC announced a voluntary recall of six lots of its injectable products Glutathione 200 mg/mL, Myer’s Cocktail and Tri-Immune Boost. The recall was issued on September 9, 2026 a…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • RA Capital backs four biotech rounds in September as Novartis shares tumble after trial setbacks
    RA Capital Management participated in four biotech financings in September, including Series A rounds for Solstice Oncology and Tectora Therapeutics, as well as co-leading a $56 million round for T…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • Karyopharm Secures One-Month Debt Extension While Awaiting Xpovio Decision
    Karyopharm Therapeutics, facing cash constraints, has negotiated a temporary reprieve on a $15.8 million debt that was due. Under the agreement, lenders and noteholders will refrain from enforceme…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • mRNA cancer vaccines’ biggest barriers to market
    Manufacturing hurdles are just one challenge the industry must overcome to commercialize personalized mRNA cancer vaccines.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • FDA plans study on barriers to women's enrollment in pregnancy exposure registries and announces PRV fee rates
    The Food and Drug Administration said it will conduct research into perceived barriers that limit women’s participation in pregnancy exposure registries. It also released the fee schedule for prio…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Whole Foods recalls Cabricharme cheese after undisclosed egg protein found
    Whole Foods Market announced a recall of its Fromagerie Coop de Mean Cabricharme cheese after testing revealed the presence of egg lysozyme, an egg-white protein that was not listed on the label.…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • FDA issues partial hold on Biohaven’s experimental epilepsy drug opakalim, pausing recruitment in late-stage trial
    Biohaven announced that the FDA has placed a partial hold on its experimental epilepsy therapy, opakalim, after the company recently transferred rights to the drug in a licensing agreement. The ag…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Reverse mergers surge as biotech firms seek public listings via shell companies
    Reverse mergers, once dismissed, are now a common route for biotech startups to gain a public listing by merging with shell companies. Data from JB Strategy Partners shows roughly two dozen such d…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • UK issues AI-in-medicine regulatory recommendations; FDA pauses new enrollment in Biohaven epilepsy trials
    The United Kingdom has released a set of recommendations aimed at governing the use of artificial intelligence in medical applications. The guidance outlines how AI tools should be evaluated and mo…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Takeda R&D chief Andy Plump to retire in June 2027, will stay on board through 2027
    Takeda announced that Andy Plump, who has led the company's research and development since 2015, will retire in June 2027. Plump will remain president of R&D until a successor is appointed and wil…
    BioPharma Dive · 1mo agoNeutral↗ source
  • FDA signals openness to innovative approaches for psychedelic drug development
    FDA officials said the agency is open to novel, innovative approaches to the clinical development of psychedelic drugs, citing the worsening mental health crisis in the United States. The agency’s…
    raps · 1mo agoRegulatoryNeutral↗ source
  • EMA revises GVP inspection guideline to incorporate new subcontractor rules
    The European Medicines Agency has issued an update to its guideline on good pharmacovigilance practice inspections. The revision aligns the guidance with recent changes to the rules governing subco…
    raps · 1mo agoRegulatoryNeutral↗ source
  • Evergreen Fresh Sprouts recalls 215 cases of broccoli sprouts over possible Salmonella contamination
    Evergreen Fresh Sprouts LLC of Moyie Springs, Idaho announced a recall of 215 cases of its broccoli sprouts due to potential Salmonella contamination. The product, packaged in 4‑oz zip‑lock bags,…
    fda recalls · 1mo agoRegulatoryNegative↗ source
  • Medical Action Industries issues correction for epidural kits containing recalled Huons Co. lidocaine ampules
    Medical Action Industries has released a correction notice for several of its epidural kit products after discovering that they contain lidocaine ampules from Huons Co. that were previously recalle…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • Solstice Oncology secures $225M Series A to advance CTLA-4 antibody porustobart in colon cancer
    Solstice Oncology, a biotech startup focused on immunotherapy, announced it has raised $225 million in a Series A financing round. The funding will support development of its lead candidate, a CTL…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Tyra Biosciences’ bladder cancer pill misses expected response rate in Phase 2 trial
    Shares of Tyra Biosciences dropped about 20% after data from its Phase 2 study of a bladder cancer pill fell short of market expectations. The experimental drug, dabogratinib, is taken daily and t…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • Kura Oncology launches Caspian Therapeutics to develop menin-inhibitor diabetes drug with $50M funding
    Kura Oncology has spun out a new biotech called Caspian Therapeutics to focus on menin inhibitors for diabetes and other cardiometabolic diseases. The company’s lead candidate, code-named KO-7246,…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • FDA appoints permanent heads of CDER and CBER, adding AI deputy role
    The Trump administration announced permanent appointments to two key FDA centers after a period of turnover. Michael Davis, who had been acting director of the Center for Drug Evaluation and Resea…
    BioPharma Dive · 1mo agoRegulatoryPositive↗ source
  • FDA appoints permanent heads of drug, biologics and tobacco centers and adds AI deputy commissioner
    The U.S. Food and Drug Administration announced permanent appointments for the leaders of its major product centers. The Center for Drug Evaluation and Research and the Center for Biologics Evalua…
    raps · 1mo agoRegulatoryNeutral↗ source