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114 stories matching this filter · ← front page

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  • 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 · 17h agoPositive readoutPositive↗ source
  • Catheter Introducer Correction: Abiomed and Oscor Issue Correction for Catheter Introducer
    Abiomed and Oscor have identified a potential for introducer sheath leakage in 14Fr and 23Fr Introducers that may increase the risk of access-site bleeding.
    fda medwatch · 1d ago↗ source
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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 · 8d 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 · 11d 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 · 10d agoNegative readoutNegative↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 12d agoApprovalPositive↗ 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 · 18d agoCRLNegative↗ source
  • FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
    The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduc…
    fda press · 24d ago↗ 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 · 25d 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 First Gene Therapy for Young Children with Sickle Cell Disease
    The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recu…
    fda press · 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
  • FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients
    The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult pat…
    fda press · 1mo ago↗ source
  • FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing
    FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufac…
    fda press · 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
  • FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes
    On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ag…
    fda press · 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
  • FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children
    The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an in…
    fda press · 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