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105 stories matching this filter · ← front page

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  • FDA expands Anktiva use for BCG-unresponsive high-grade papillary bladder cancer
    The U.S. Food and Drug Administration has broadened the approved use of Anktiva, a therapy given with Bacillus Calmette-Guérin, to treat adults with high-grade papillary-only bladder cancer that ha…
    fda press · 5d agoApprovalPositive↗ source
  • FDA approves first pediatric heart valve that expands as children grow
    The U.S. Food and Drug Administration has approved the Autus Size-Adjustable Valve, a surgically implanted pulmonary heart valve for children with congenital pulmonary valve disease. The device is…
    fda press · 18d agoApprovalPositive↗ source
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  • FDA approves Emcitate for peripheral thyrotoxicosis in patients with MCT8 deficiency
    The U.S. Food and Drug Administration announced approval of Emcitate (tiratricol) tablets formulated for oral suspension to treat peripheral thyrotoxicosis in patients with MCT8 deficiency, also ca…
    fda press · 21d agoApprovalPositive↗ source
  • FDA Approves First Gene Therapy for Pediatric Patients with Sanfilippo Syndrome Type A
    The U.S. Food and Drug Administration today approved Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with mucopolysaccharidosis type IIIA (MPS IIIA), also known…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA grants accelerated approval for Etcamah combo therapy for advanced HR-positive, HER2-negative breast cancer
    The U.S. Food and Drug Administration announced accelerated approval of Etcamah (camizestrant) in combination with a CDK4/6 inhibitor for adult patients with hormone-receptor-positive, HER2-negativ…
    fda press · 1mo agoApprovalPositive↗ 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 approves Mimrylo, first hepcidin-mimicking drug for polycythemia vera
    The U.S. Food and Drug Administration announced approval of Mimrylo (rusfertide) for adult patients with polycythemia vera, a rare blood disorder that causes excess red blood cells. The drug mimic…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA clears first wearable that continuously tracks both glucose and ketone levels
    The U.S. Food and Drug Administration has authorized the Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System for individuals aged two years and older who have diabetes. The device is…
    fda press · 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 accelerated approval to Genglycos, first therapy for glycogen storage disease type Ia
    The U.S. Food and Drug Administration issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr), marking the first therapy for patients aged eight years and older with glycogen…
    fda press · 2mo agoApprovalPositive↗ source
  • FDA authorizes Aletta, first standalone robotic device for automated blood draws
    The U.S. Food and Drug Administration announced it has authorized Aletta, a robotic system that can draw blood without hands‑on operator involvement. The device is cleared for adult use in outpati…
    fda press · 2mo agoRegulatoryPositive↗ 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
  • 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 · 2mo agoApprovalPositive↗ source
  • FDA approves Lipfendra, first oral PCSK9 inhibitor, to lower LDL cholesterol in adults
    The U.S. Food and Drug Administration has approved Lipfendra (enlicitide), the first oral inhibitor of the PCSK9 protein, for use as an adjunct to diet and exercise in adults with high cholesterol,…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA Grants First Gene-Therapy Approval for Children 2+ with Sickle Cell Disease
    The U.S. Food and Drug Administration issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged two years and older who have sickle cell disease with recurrent vaso-oc…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA approves Tregzi, first T‑reg cell therapy to lower chronic GVHD risk in blood‑cancer transplants
    The FDA announced approval of Tregzi, a regulatory T‑cell based immunotherapy designed to improve chronic graft‑versus‑host disease‑free survival for adults with blood cancers undergoing allogeneic…
    fda press · 3mo agoApprovalPositive↗ source
  • FDA picks seven firms for PreCheck pilot to boost U.S. drug manufacturing
    The FDA announced on June 29, 2026 that seven companies have been chosen for its PreCheck Pilot Program, an initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience. T…
    fda press · 3mo agoRegulatoryPositive↗ source
  • FDA grants accelerated approval for Tzield to delay insulin loss in children with newly diagnosed Stage 3 type 1 diabetes
    The U.S. Food and Drug Administration issued an accelerated approval on June 12, 2026 for Tzield (teplizumab) to slow the decline of insulin production in pediatric patients aged 8 to 17 who have r…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA clears Dexcom's Stelo as first OTC continuous glucose monitor for children
    The U.S. Food and Drug Administration cleared Dexcom's Stelo Glucose Biosensor System for over-the-counter use in children two years of age and older who do not use insulin. This is the first OTC…
    fda press · 4mo agoApprovalPositive↗ source
  • FDA Approves First Treatment for Chronic Hepatitis Delta Virus (HDV) Infection
    Today, the U.S. Food and Drug Administration approved Hepcludex (bulevirtide-gmod) injection to treat chronic hepatitis delta virus (HDV) infection in adults without cirrhosis (advanced liver scarr…
    fda press · 5mo agoApprovalPositive↗ source
  • Dr. Hunter outlines anemia treatment options for myelofibrosis patients
    Dr. Anthony M. Hunter, a hematology specialist, discussed how clinicians approach anemia in patients with myelofibrosis. He highlighted luspatercept as one therapeutic option, noting its mechanism…
    onclive · 5mo agoNeutral↗ source
  • FDA approves oral decitabine/cedazuridine plus venetoclax for older AML patients unable to tolerate intensive chemo
    The FDA has approved the oral combination of decitabine/cedazuridine (Inqovi) with venetoclax (Venclexta) for adults with newly diagnosed acute myeloid leukemia who are at least 75 years old or hav…
    onclive · 5mo agoApprovalPositive↗ source
  • FDA approves all-oral decitabine/cedazuridine plus venetoclax for older or unfit AML patients
    The FDA has granted approval for the combination of decitabine and cedazuridine (Inqovi) with venetoclax (Venclexta) to treat newly diagnosed acute myeloid leukemia in adults who are at least 75 ye…
    onclive · 5mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma
    The U.S. Food and Drug Administration has granted accelerated approval to sonrotoclax (brand name Beqalzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at l…
    onclive · 5mo agoApprovalPositive↗ source