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15 stories matching this filter · ← front page

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allOncology6029Rare Disease1434Cardiology1089Hematology1025Immunology1000Vaccines902Pulmonology
  • Regeneron wins FDA approval for Pasatru, targeting rare bone disease FOP
    The U.S. Food and Drug Administration has approved Regeneron Pharmaceuticals' drug Pasatru for the treatment of fibrodysplasia ossificans progressiva (FOP), a very rare condition in which muscle an…
    BioPharma Dive · 5h agoApprovalPositive↗ source
  • FDA approves Regeneron’s garetosmab for ultra-rare bone-forming disease
    The FDA has granted approval to Regeneron's antibody garetosmab, which targets activin A, for the treatment of fibrodysplasia ossificans progressiva (FOP). FOP is an ultra‑rare disorder that causes…
    Endpoints · 1d agoApprovalPositive↗ source
73
fda recalls47
fda medwatch38
fda press28
899
Psychiatry & CNS712
Ophthalmology421
Endocrinology & Metabolism382
Pain376
Infectious Disease356
  • BioMarin to buy Alesta Therapeutics for $275M, adding rare bone disease drug to pipeline
    BioMarin announced Tuesday that it will acquire privately held Alesta Therapeutics, paying $275 million upfront with potential additional payments tied to milestones. The deal, expected to close b…
    BioPharma Dive · 2d agoDealPositive↗ source
  • BioMarin signs new deal for early-stage bone disease asset
    BioMarin recently halted development of a rare disease drug that it had acquired in a $270 million transaction. Within a week, the company announced another deal to acquire an early‑stage asset aim…
    Endpoints · 2d agoDealNeutral↗ source
  • FDA grants accelerated approval to Bristol Myers' Zenbexus, first CELMoD for multiple myeloma
    The FDA issued an accelerated approval on Thursday for Zenbexus, a multiple myeloma therapy that Bristol Myers Squibb inherited from its Celgene acquisition. Zenbexus belongs to a new class of pro…
    BioPharma Dive · 6d 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 · 14d 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 · 16d agoDealPositive↗ 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 · 29d agoRegulatoryPositive↗ source
  • Nava Therapeutics raises $89 million to advance lipid nanoparticle platform targeting bone marrow, immune cells and kidney
    Nava Therapeutics, a stealth-mode biotech, announced it has secured $89 million in financing, according to a statement to Endpoints News. The capital will support development of a next generation…
    Endpoints · 1mo agoDealPositive↗ 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