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18 stories matching this filter · ← front page

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STAT1542Endpoints1211BioSpace551Fierce Biotech545BioPharma Dive461raps189onclive165fda recalls
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allOncology10308Rare Disease2684Immunology2407Cardiology2275Hematology1865Pulmonology1837Vaccines
  • 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 Zanvastro, first therapy targeting protein buildup in Alexander disease
    The U.S. Food and Drug Administration has approved Zanvastro (zilganersen) injection for the treatment of Alexander disease in both pediatric and adult patients. Zanvastro is the first FDA-approve…
    fda press · 1mo agoApprovalPositive↗ source
102
fda medwatch89
globenewswire health73
fda press51
1609
Psychiatry & CNS1100
Ophthalmology840
Endocrinology & Metabolism682
Pain650
Nephrology627
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 1mo agoApprovalPositive↗ source
  • FDA grants accelerated approval to Tudriqev viral therapy for PD-1-refractory advanced melanoma
    The U.S. Food and Drug Administration has granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically engineered oncolytic viral therapy for patients with advanced, tre…
    fda press · 2mo agoApprovalPositive↗ source
  • OKYO Pharma CSO Raj Patil boosts stake to 20,030 shares
    OKYO Pharma, a clinical stage biotech focused on neuropathic corneal pain and anterior segment eye diseases, disclosed that its chief scientific officer, Raj Patil, PhD, bought additional shares.…
    globenewswire health · 2mo agoDealNeutral↗ source
  • Australia's TGA adopts 23 international scientific guidelines from EMA, ICH and FDA
    The Therapeutic Goods Administration (TGA) in Australia announced it has formally adopted 23 scientific guidelines. The guidelines come from the European Medicines Agency, the International Counci…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA advisory panel recommends adding peptides BPC-157 and KPV to bulk compounding list
    An FDA advisory committee voted 8-6, with one abstention, to recommend that two experimental peptides – BPC-157 for ulcerative colitis and KPV for wound and inflammatory conditions – be placed on t…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA advisory panel adds six peptides to compounding bulk drug list, rejects one
    The FDA’s advisory committee concluded a two-day meeting on Friday, reviewing seven peptide drug substances for inclusion on the agency’s bulk-drug compounding list. Committee members voted to add…
    raps · 2mo agoRegulatoryNeutral↗ 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 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 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
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 5mo agoPositive↗ source
  • Dr Randall explains rationale for CSF-1R inhibitor pimicotinib in tenosynovial giant cell tumor trial
    Dr Randall, a professor at UC Davis Comprehensive Cancer Center, discussed the clinical reasoning behind testing the selective CSF-1R inhibitor pimicotinib (ABSK021) for tenosynovial giant cell tum…
    onclive · 5mo agoNeutral↗ source
  • FDA approves zenocutuzumab for previously treated NRG1-fusion cholangiocarcinoma
    The FDA has granted approval for zenocutuzumab to treat patients with previously treated, advanced cholangiocarcinoma that carries an NRG1 fusion. The decision was based on data from the eNRGy stud…
    onclive · 5mo agoApprovalPositive↗ source
  • Pimicotinib shows 76% response rate and functional benefits in TGCT phase 3 trial
    Dr. Randall discussed results from the phase 3 MANEUVER trial of the CSF-1 receptor inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data were presented at the 2025…
    onclive · 5mo agoPositive readoutPositive↗ source
  • FDA approves Zenocutuzumab for NRG1 fusion-positive advanced cholangiocarcinoma
    The U.S. Food and Drug Administration has granted approval for zenocutuzumab-zbco, marketed as Bizengri, to treat adult patients with NRG1 fusion‑positive advanced, unresectable or metastatic chola…
    onclive · 5mo agoApprovalPositive↗ source
  • Phase 3 MANEUVER trial shows pimicotinib improves response and pain in advanced TGCT, supporting FDA NDA acceptance
    The phase 3 MANEUVER study evaluated pimicotinib in patients with advanced diffuse tenosynovial giant cell tumor. The trial compared the oral agent to placebo and collected both clinical and patien…
    onclive · 5mo agoPositive readoutPositive↗ source