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11 stories matching this filter · ← front page

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STAT925Endpoints712BioPharma Dive273onclive165BioSpace162Fierce Biotech152globenewswire health73raps
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allOncology5421Rare Disease1144Cardiology988Hematology887Immunology834Pulmonology704Psychiatry & CNS
  • 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 · 4d agoApprovalPositive↗ source
  • Hinge Health to acquire Cylinder Health for $105 million, expanding into digestive care
    Hinge Health, known for virtual physical therapy, announced it will purchase digestive health startup Cylinder Health. The transaction is a cash deal valued at $105 million, marking Hinge's latest…
    Endpoints · 6d agoDealPositive↗ source
55
fda recalls35
fda press24
fda medwatch23
645
Vaccines612
Endocrinology & Metabolism325
Ophthalmology315
Pain308
Infectious Disease300
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 12d agoCRLNegative↗ source
  • FDA selects Dexcom as first participant in TEMPO digital health pilot
    The U.S. Food and Drug Administration announced that Dexcom, Inc. has been chosen as the inaugural manufacturer for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot focused on digit…
    fda press · 19d agoRegulatoryPositive↗ source
  • Nava Therapeutics emerges with $89M for lipid nanoparticles
    Nava Therapeutics, a secretive startup that’s been working on a new generation of lipid nanoparticles that target the bone marrow, immune cells and the kidney, has raised $89 million, the company t…
    Endpoints · 27d 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 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
  • Ipsen’s $450M blood cancer drug; FDA selects first cohort for “pre-check” pilot program
    The planned acquisition of Kartos Therapeutics would hand Ipsen a late-stage asset for myelofibrosis. Elsewhere, Sobi hit a regulatory setback and BeOne unveiled more positive Brukinsa data.
    BioPharma Dive · 1mo ago↗ source
  • Biotech SPAC deal gets it to Nasdaq; AstraZeneca Phase 3 win in bone disease
    Plus news about Alebund Pharmaceuticals, Regenxbio and Neuphoria Therapeutics. 💸 A SPAC!: Talawar Therapeutics will land on the Nasdaq via a combination with blank-check company JATT II Acquisitio…
    Endpoints · 1mo ago↗ source
  • Incyte to buy blood disorder drug in possibly $2B deal
    Acquiring Vega Therapeutics, an offshoot of "hub-and-spoke" biotech Star Therapeutics, would give Incyte a medicine that’s in late-stage testing and designed to control bleeding.
    BioPharma Dive · 2mo ago↗ source
  • A year after Vertex’s big launch, pain drug research faces a pivotal moment
    Journavx revived an area of development long considered a graveyard. Can any other pain drugs keep investor excitement going?
    BioPharma Dive · 3mo ago↗ source