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21 stories matching this filter · ← front page

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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 · 2d 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 · 3d agoPositive readoutPositive↗ source
59
fda recalls39
fda medwatch29
fda press25
768
Psychiatry & CNS677
Ophthalmology338
Endocrinology & Metabolism335
Pain328
Infectious Disease320
  • 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 recalls · 3d agoCRLNegative↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda recalls · 7d agoCRLNegative↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda recalls · 9d agoCRLNegative↗ 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 · 13d agoNegative readoutNegative↗ source
  • Liebel-Flarsheim recalls OPTIRAY imaging contrast agent after detecting plastic, metal and glass particles
    Liebel-Flarsheim Company announced a recall of one lot of its OPTIRAY Imaging Bulk Package, a 350/500 mL vial of ioversol injection used for intra‑arterial and intravenous imaging. The recall was…
    fda recalls · 13d agoCRLNegative↗ source
  • Baxter recalls cefazolin injection after cardboard particles detected
    Baxter International announced a voluntary nationwide recall of lot LD175708 of its cefazolin in dextrose injection, a single‑dose 100 ml infusion bag. The recall was prompted by a report that car…
    fda recalls · 20d agoCRLNegative↗ source
  • Baxter voluntarily recalls Cefazolin in Dextrose injection after cardboard particles found
    Baxter International announced a voluntary nationwide recall of Lot LD175708 of its Cefazolin in Dextrose Injection, a single-dose infusion bag. The recall follows a report that cardboard particle…
    fda recalls · 20d agoCRLNegative↗ source
  • FDA approves Orca Bio’s cell therapy to improve transplant outcomes
    The FDA gave the go-ahead to Orca Bio’s T cell therapy that would reduce transplant-related complications for blood cancer patients. The therapy will be branded as Tregzi, an homage to the regulato…
    Endpoints · 1mo ago↗ source
  • Ipsen to buy blood cancer company Kartos Therapeutics for $450M upfront
    Ipsen is earmarking up to $1.75 billion to take Kartos Therapeutics and its MDM2 protein-targeting drug candidate that it in-licensed from Amgen back in 2016. Ipsen will pay $450 million upfront ...
    Endpoints · 1mo ago↗ source
  • Lilly puts its stamp at #EHA26 with Jaypirca combo data in CLL, first clinical data from Ajax buyout
    Eli Lilly made a push in blood cancer at this year’s European Hematology Association meeting in Stockholm over the weekend. The drugmaker presented data for Jaypirca combined with the standard of c…
    Endpoints · 1mo ago↗ source
  • Incyte CEO sees $2B Vega deal aiding a post-Jakafi future
    Bill Meury has been in or led the C-suite of several biopharma companies that have constructed multibillion-dollar exits over the past decade: Allergan, Karuna and Anthos. Now, he’s the one buying.…
    Endpoints · 2mo ago↗ source
  • #ASCO26: Grail’s cancer blood test isn’t ready for widespread use, experts say
    CHICAGO — Grail's blood test, which it has pitched as a way to spot a variety of cancers early in their growth, still isn't ready to be used as a regular screening tool, experts not involved ...
    Endpoints · 2mo ago↗ source
  • Agios ends development of tebapivat in low-risk MDS following subpar results
    Agios Pharmaceuticals has said it will stop developing its rare blood disorder drug for certain patients with myelodysplastic syndromes (MDS) due to disappointing Phase 2b data. The biotech’s pyruv…
    Endpoints · 2mo ago↗ source
  • AbbVie clinches FDA approval for ultra-rare blood cancer ADC from ImmunoGen purchase
    AbbVie said the FDA has approved an antibody-drug conjugate it obtained as part of its $10.1 billion buyout of ImmunoGen for an ultra-rare but aggressive form of blood cancer. On Wednesday, the ...
    Endpoints · 2mo ago↗ source
  • FDA approves AstraZeneca’s baxdrostat for certain patients with hypertension
    One of the key products underpinning AstraZeneca’s goal of hitting $80 billion in revenue by 2030 has been approved by the FDA, the drugmaker said Monday. The blood ...
    Endpoints · 2mo ago↗ source
  • BeOne’s next-gen BCL2 inhibitor wins FDA approval, taking aim at Venclexta
    BeOne Medicines has clinched an accelerated approval for its drug sonrotoclax in mantle cell lymphoma (MCL), marking the start of its bid to challenge AbbVie and Roche's Venclexta across a range of…
    Endpoints · 3mo ago↗ source
  • #ASGCT26: Tessera reveals strongest data yet for in vivo sickle cell therapy
    BOSTON — Tessera Therapeutics has created an experimental gene editing drug for sickle cell disease that could compete with commercial cell therapies but is delivered as an infusion — no complex ce…
    Endpoints · 3mo ago↗ source
  • Second life for gene therapy; Takeda Phase 2/3 win; UK cancer biotech's $83M
    A blood test might predict who will respond to Wegovy; Viridian's thyroid eye disease drug wins another Phase 3; Ideaya drops two GSK-returned assets. 🧬 Second life for a gene therapy: A Cleveland…
    Endpoints · 3mo ago↗ source
  • Novo's pill for kids; Altimmune’s $225M offering; Merck teams with Google Cloud
    Novo Nordisk’s GLP-1 pill works in kids with diabetes: Type 2 diabetes patients aged 10 to 17 who took Rybelsus for about six months had a statistically significant 0.83% cut in their blood sugar l…
    Endpoints · 3mo ago↗ source