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  • Swiss startup Vaderis raises $152 million to fund Phase 3 trial of rare bleeding disorder therapy
    Vaderis Therapeutics, a 13‑person Swiss biotech, announced a $152 million Series B financing round aimed at advancing its experimental therapy into a Phase 3 study. The company is testing a treatm…
    Endpoints · 9d agoDealPositive↗ source
  • Hamilton Medical issues recall of coaxial breathing circuit sets for C1, T-1 and MR1 ventilators
    Hamilton Medical has recalled specific coaxial breathing circuit sets used with its C1, T-1 and MR1 ventilators after the FDA classified the issue as a Class I recall, the most serious level, due t…
    fda medwatch · 9d agoCRLNegative↗ source
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  • Fresenius Kabi recalls Tyenne (tocilizumab-aazg) 400 mg injection vials over glass particle contamination
    Fresenius Kabi announced a recall of a specific lot of its Tyenne (tocilizumab-aazg) injection, 400 mg/20 mL vials, after detecting glass particles in the product. The company said the contaminati…
    fda medwatch · 9d agoCRLNegative↗ source
  • Lidl US Recalls Vitasia Asian Style Wok Spice Mix Due to Potential Salmonella Contamination
    ARLINGTON, VA – AUGUST 11, 2026 – Lidl US is recalling one lot of Vitasia Asian Style Wok Spice Mix 1.58 oz (45g) (UPC 4335619355491) with Lot # 155846 and BBD JUN 2028 because it has the potential…
    fda recalls · 8d agoRegulatoryNeutral↗ source
  • Health insurers' AI spending meets reality check as UnitedHealth pledges $1.5 billion and CVS outlines its own budget
    Two of the largest publicly traded health insurers are emphasizing their artificial‑intelligence initiatives, but industry observers say the hype may outpace actual results. UnitedHealth Group dis…
    Endpoints · 9d agoNeutral↗ source
  • Henkel recalls Schwarzkopf Professional Osis Grip mousse in U.S. over packaging leak risk
    Henkel Corp announced a voluntary recall of its Schwarzkopf Professional Osis Grip mousse (6.76 fl oz/200 ml) sold in the United States. The recall is due to a potential packaging defect that coul…
    fda recalls · 9d agoCRLNegative↗ source
  • Frankie's Organic recalls vegan cheddar puffs over undeclared milk, warning allergic consumers
    Frankie's Organic Foods Inc. announced a recall of 94 cases of its Plant-Based Vegan Cheddar Puffs after discovering the snack may contain undeclared milk, creating a serious risk for people with m…
    fda recalls · 9d agoCRLNegative↗ source
  • FDA rejects ITM radiopharma therapy while WHO defends immunization schedules
    The U.S. Food and Drug Administration has issued a rejection of a radiopharmaceutical therapy identified as ITM, indicating that the product did not meet the agency's requirements for approval. Th…
    raps · 9d agoRegulatoryNeutral↗ source
  • PIC/S releases revised guide on qualification and validation studies for pharma manufacturing
    PIC/S has issued an updated guideline that outlines general principles for qualification and validation studies in pharmaceutical manufacturing facilities. The new guide is intended for both inspe…
    raps · 9d agoRegulatoryNeutral↗ source
  • AbbVie, Novartis and Bristol Myers Squibb sue Illinois over 340B drug discount law
    AbbVie, Novartis and Bristol Myers Squibb each filed separate lawsuits in Illinois this week. The suits challenge a state law that seeks to regulate how manufacturers participate in the 340B drug…
    Endpoints · 8d agoRegulatoryNeutral↗ source
  • Salata Dressings recalls Jalapeno Avocado Dressing over possible Salmonella contamination
    Salata Dressings of Houston, Texas announced a recall of its Jalapeno Avocado Dressing because the product may be contaminated with Salmonella. The recall was issued on August 11, 2026 and the FDA…
    fda recalls · 8d agoCRLNegative↗ source
  • AbCellera reports striking Phase 2 results for hot-flash treatment, shares jump 31%
    AbCellera Biologics announced positive Phase 2 data for its neurokinin-3 receptor antagonist aimed at relieving vasomotor symptoms such as hot flashes. The company described the results as strikin…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • Jazz Pharmaceuticals to acquire Actio Biosciences for $820 million upfront, targeting ultra-rare epilepsy
    Jazz Pharmaceuticals announced it will purchase Actio Biosciences, a company developing an ultra‑rare epilepsy therapy. The transaction includes an upfront cash payment of $820 million, with the p…
    Endpoints · 10d agoDealPositive↗ source
  • BMS to build $2.3 B Houston plant as MHRA clears Lilly's weight-loss drug; IMDRF issues PCCP guidance
    Bristol Myers Squibb announced a plan to invest about $2.3 billion in a new manufacturing facility in Houston. The site is expected to expand the company’s production capacity for its pipeline and…
    raps · 10d agoRegulatoryNeutral↗ source
  • Trump orders MMR vaccine to be administered as three separate shots, citing autism concerns
    President Donald Trump announced via an executive order that the combined measles, mumps and rubella (MMR) vaccine should be split into three individual injections for children. He claimed the cha…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • FDA rejects ITM's radiopharma drug for neuroendocrine tumors over manufacturing issues
    The U.S. Food and Drug Administration has refused to approve a radiopharmaceutical candidate from ITM Isotope Technologies Munich intended for treating neuroendocrine tumors. The agency cited manu…
    Endpoints · 9d agoRegulatoryNegative↗ source
  • Bristol Myers Squibb announces $2.3 billion manufacturing campus in Houston
    Bristol Myers Squibb disclosed plans to build a new manufacturing campus in Houston, Texas, with an estimated cost of $2.3 billion. The campus will expand the company's domestic production capacit…
    Endpoints · 9d agoDealPositive↗ source
  • Federal judge suspends Pentagon's designation of WuXi AppTec as a Chinese military-linked firm
    A U.S. district judge has temporarily halted the Pentagon’s effort to label WuXi AppTec as a company with ties to the Chinese military. The ruling was issued by Judge James Boasberg, who found the…
    Endpoints · 9d agoRegulatoryNeutral↗ source
  • Sionna Therapeutics reports early-stage cystic fibrosis trial failure, dampening challenge to Vertex
    Sionna Therapeutics said its lead cystic fibrosis drug did not meet primary endpoints in an early-stage study, marking a setback for the company. The result reduces expectations that Sionna could…
    Endpoints · 10d agoNegative readoutNegative↗ source
  • Silence Therapeutics moves siRNA drug for polycythemia vera to Phase 3 after Phase 2 success
    Silence Therapeutics announced that its siRNA candidate divesiran achieved its primary endpoint in a Phase 2 study in patients with polycythemia vera, a rare blood cancer. The trial results showed…
    Endpoints · 10d agoPositive readoutPositive↗ source
  • Abiomed and Oscor advise correction of Impella catheter introducers due to leakage risk
    Abiomed and its partner Oscor have issued a notice about a potential leakage in certain catheter introducer sheaths used with Impella heart pumps. The issue involves 14Fr and 23Fr introducer kits,…
    fda medwatch · 10d agoCRLNeutral↗ source
  • FDA issues warning letters to Indian OTC drugmaker over falsified logbooks and cites GMP lapses at two other firms
    The FDA sent warning letters to an over‑the‑counter drug manufacturer in India after discovering the company had submitted falsified production logbooks. The agency also cited two additional OTC m…
    raps · 10d agoRegulatoryNegative↗ source
  • FDA issues warning letters to Indian OTC drugmaker for falsified logbooks and to two others for GMP testing lapses
    The U.S. Food and Drug Administration sent a warning letter to an over‑the‑counter drugmaker in India after discovering that the company had submitted falsified logbooks to the agency. In addition…
    raps · 10d agoRegulatoryNegative↗ source
  • RevMed partners with BeOne for Asian rights to RAS drugs as MoonLake reports Phase 3 success
    RevMed and BeOne have entered a partnership granting BeOne rights to commercialize RevMed’s RAS pathway drugs in selected Asian markets. The agreement also includes collaboration on upcoming clini…
    Endpoints · 10d agoDealPositive↗ source
  • BioNTech veteran secures $25M seed round for virtual cancer surveillance startup
    A new virtual cancer surveillance company has closed a $25 million seed round, with the funding led by investors attracted to its novel approach to monitoring tumors. The company is headed by Ryan…
    Endpoints · 10d agoDealPositive↗ source