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30 stories matching this filter · ← front page

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  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 21d agoRegulatoryNeutral↗ source
  • Roche's Lunsumio clears Phase 3 hurdle, paving way for broader label in indolent lymphoma
    Roche announced that its T cell engager Lunsumio successfully met the primary endpoints in a Phase 3 study of a slow growing blood cancer. The trial, conducted in patients with indolent lymphoma,…
    Endpoints · 1mo agoPositive readoutPositive↗ source
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Nephrology627
  • GSK signs new agreement with China's Chimagen for trispecific T-cell engager targeting blood cancers
    GSK, the UK‑based pharmaceutical company, has entered into a fresh licensing agreement with Chinese biotech Chimagen Biosciences. The partnership focuses on a trispecific T‑cell engager designed fo…
    Endpoints · 1mo agoDealPositive↗ source
  • Bristol Myers reports Phase 2 success for GPRC5D‑directed CAR‑T therapy
    Bristol Myers announced positive Phase 2 results for its GPRC5D‑directed CAR‑T therapy aimed at treating multiple myeloma. The study demonstrated encouraging efficacy signals, adding to the growing…
    Endpoints · 1mo agoPositive readoutPositive↗ source
  • Novartis halts CD19 CAR-T trial after three deaths, Bristol Myers also pauses similar program
    Novartis announced a pause to its CD19-directed CAR-T cell therapy trials after three patients experienced fatal immune reactions. The company said the deaths were linked to a severe cytokine relea…
    Endpoints · 1mo agoCRLNegative↗ source
  • FDA clears Protagonist-Takeda therapy for rare blood cancer as Lilly moves to buy Merida for up to $2.88 billion
    The U.S. Food and Drug Administration has granted approval to a collaborative therapy from Protagonist and Takeda aimed at treating a rare form of blood cancer. This regulatory decision adds a new…
    raps · 1mo agoDealPositive↗ source
  • FDA greenlights Takeda and Protagonist's rusfertide (Mimrylo) for polycythemia vera
    The U.S. Food and Drug Administration has granted approval to rusfertide, a therapy developed jointly by Takeda Pharmaceutical and Protagonist Therapeutics. The drug, to be marketed under the name…
    Endpoints · 1mo agoApprovalPositive↗ source
  • J&J’s Imaavy gains first-in-class label for warm autoimmune hemolytic anemia
    J&J announced that its monoclonal antibody Imaavy has received a label expansion in the United States. The expanded indication makes Imaavy the first therapy approved specifically for warm autoimm…
    Endpoints · 1mo agoApprovalPositive↗ source
  • FDA clears Roche and Lilly Alzheimer’s blood tests, while Regenxbio gene therapy trial halted again
    The U.S. Food and Drug Administration announced it has granted clearance for blood-based diagnostic tests for Alzheimer’s disease developed by Roche and Eli Lilly. The clearances allow the compani…
    raps · 1mo agoRegulatoryNeutral↗ source
  • FDA grants approval to Ultragenyx's Genglycos gene therapy for ultra-rare glycogen storage disorder
    Ultragenyx announced that the U.S. Food and Drug Administration has approved its gene therapy called Genglycos. The therapy targets an ultra-rare glycogen storage disorder that can lead to severe…
    Endpoints · 2mo agoApprovalPositive↗ source
  • Amylyx reports Phase 3 success for avexitide in post-bariatric hypoglycemia
    Amylyx announced a late-stage success for avexitide, a GLP-1 receptor antagonist, in a Phase 3 trial targeting post-bariatric hypoglycemia. The trial results showed the drug achieved its primary e…
    Endpoints · 2mo agoPositive readoutPositive↗ source
  • FDA approves Zenbexus for multiple myeloma as NSAI looks to sell MDR notified body unit
    The U.S. Food and Drug Administration has granted approval for Zenbexus to be used in the treatment of multiple myeloma, marking a new therapeutic option for patients with this blood cancer. The a…
    raps · 2mo agoApprovalPositive↗ source
  • ICER finds AstraZeneca’s blood pressure pill Baxfendy not cost-effective at $10,950 a year
    ICER released a report saying the clinical benefits of AstraZeneca’s new blood pressure medication Baxfendy do not justify its listed price. The agency noted the drug is priced at $10,950 per pati…
    Endpoints · 2mo agoRegulatoryNegative↗ source
  • 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 · 2mo agoDealPositive↗ 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 · 2mo agoPositive readoutPositive↗ source
  • Karyopharm stock tumbles after Phase 3 Xpovio trial fails in endometrial cancer
    Karyopharm announced that its Phase 3 XPORT-EC-042 study of Xpovio in endometrial cancer did not meet its primary endpoint. The failure represents the company's second unsuccessful attempt to expa…
    Endpoints · 2mo agoNegative readoutNegative↗ source
  • Hengrui and Kailera's oral GLP-1 pill shows promising efficacy but notable side effects in Chinese obesity and diabetes trials
    Hengrui Pharma and Kailera Therapeutics reported results from two late‑stage trials in China, one targeting obesity and the other diabetes, using their daily oral GLP‑1 pill. The studies demonstrat…
    Endpoints · 3mo agoPositive readoutNeutral↗ source
  • Vertex's Casgevy gene therapy receives FDA approval for children with sickle cell disease and beta-thalassemia
    Vertex announced that its gene therapy Casgevy has been granted FDA approval for use in pediatric patients. The decision expands the therapy's reach beyond adult indications. Casgevy is now author…
    Endpoints · 3mo agoApprovalPositive↗ source
  • FDA approves Orca Bio's T cell therapy Tregzi to lower transplant complications in blood cancer patients
    The U.S. Food and Drug Administration has granted approval to Orca Bio's T cell therapy aimed at improving outcomes for patients undergoing blood cancer transplants. The therapy, named Tregzi, is…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Ipsen to acquire blood-cancer specialist Kartos Therapeutics for $450 million upfront
    Ipsen announced it will purchase Kartos Therapeutics, a company focused on blood cancers. The transaction includes a $450 million cash payment at closing, with the possibility of up to $1.75 billi…
    Endpoints · 3mo agoDealPositive↗ source
  • Lilly showcases Jaypirca combination data in CLL at EHA26, debuting results from Ajax acquisition
    Eli Lilly highlighted new blood‑cancer data at the European Hematology Association meeting in Stockholm. The company presented early clinical results for its Jaypirca therapy combined with the stan…
    Endpoints · 4mo agoNeutral↗ source
  • Incyte CEO frames $2 billion Vega acquisition as key to post-Jakafi strategy
    Incyte's chief executive Bill Meury said the company’s recent $2 billion purchase of Vega is intended to expand its blood‑disorder pipeline beyond the already‑approved Jakafi. Meury, who has previ…
    Endpoints · 4mo agoDealPositive↗ source
  • Experts say Grail’s multi-cancer blood test not yet ready for routine screening
    At the ASCO 2026 meeting in Chicago, Grail presented its multi-cancer early detection blood test, which the company markets as a tool to identify several cancers at an early stage. Independent exp…
    Endpoints · 4mo agoNegative↗ source
  • Agios halts development of tebapivat for low-risk MDS after disappointing Phase 2b data
    Agios Pharmaceuticals announced it will discontinue development of its pyruvate kinase activator tebapivat for patients with low-risk myelodysplastic syndromes (MDS). The decision follows the relea…
    Endpoints · 4mo agoNegative↗ source
  • AbbVie receives FDA approval for ultra-rare blood cancer ADC acquired from ImmunoGen
    AbbVie announced that the U.S. Food and Drug Administration has granted approval for an antibody-drug conjugate targeting an ultra-rare, aggressive form of blood cancer. The therapy was obtained t…
    Endpoints · 4mo agoApprovalPositive↗ source