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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 · 1d agoDealPositive↗ source
  • 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 · 1d agoCRLNegative↗ source
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Pain320
Infectious Disease314
  • 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 · 2d 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 · 2d agoCRLNeutral↗ 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 medwatch · 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 medwatch · 7d agoCRLNegative↗ 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 medwatch · 8d agoCRLNegative↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 9d agoCRLNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 12d 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 · 12d agoNegative readoutNegative↗ source
  • American Regent recalls one lot of Papaverine Hydrochloride injection over glass particles
    American Regent announced a voluntary nationwide recall of a single lot of its Papaverine Hydrochloride Injection, USP 60 mg/2 mL, after detecting visible particulate matter. The particles were id…
    fda medwatch · 16d agoCRLNegative↗ source
  • FDA issues early alert on Boston Scientific ENROUTE catheter tip separation risk
    The CDRH has issued an Early Alert warning about a potential high risk issue with Boston Scientific's ENROUTE Transcarotid Neuroprotection System and its Plus version. The problem involves possibl…
    fda medwatch · 19d agoCRLNegative↗ source
  • Thoracic Stent Graft Recall: Bolton Medical Removes Relay Pro System
    Affected grafts may not unclasp from the delivery system. This may require conversion to open surgical repair and can result in patient death.
    fda medwatch · 26d ago↗ source
  • Early Alert: Convenience Kit Issue from Medical Action Industries
    Particulates have the potential to be introduced into blood circulation and become lodged within blood vessels.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for Ivenix Large Volume Infusion Pump
    A software anomaly may cause a false battery-health value. The pump should remain plugged in at all times.
    fda medwatch · 1mo ago↗ source
  • Infusion Pump Correction: Fresenius Kabi Issues Correction for dropped or jarred Ivenix Large Volume Infusion Pumps
    If dropped, the Ivenix pump touchscreen may become unresponsive and should be removed from use.
    fda medwatch · 1mo ago↗ source
  • Convenience Kit Correction: Windstone Medical Packaging, Inc. Issues Correction for Convenience Kit
    Certain Cardinal Health Webcol Large Alcohol Prep Pads in Custom Convenience Kits manufactured by Aligned Medical Solutions are not sterile.
    fda medwatch · 1mo ago↗ 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