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2,016 stories matching this filter · ← front page

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  • AbbVie receives FDA approval for Parkinson’s drug Juvmo, a Cerevel acquisition asset
    AbbVie has secured FDA approval for tavapadon, marketed as Juvmo, for the treatment of Parkinson’s disease in adults. The decision follows positive results from the Phase 3 TEMPO trial. In the piv…
    BioSpace · 23d agoApprovalPositive↗ source
  • Kodiak Sciences' zenkuda and tabirafusp-ted match Eylea in Phase 3, sending stock up 166%
    Kodiak Sciences announced Phase 3 results for two investigational eye‑disease drugs, zenkuda (anti‑VEGF antibody biopolymer conjugate) and tabirafusp‑ted (anti‑IL‑6/VEGF bispecific), which performe…
    BioSpace · 22d agoPositive readoutPositive↗ source
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  • Mirum receives FDA approval for Atebrioz, third therapy for ultra-rare bone disease FOP
    Mirum Pharmaceuticals announced that the U.S. Food and Drug Administration approved its ALK2 inhibitor, zilurgisertib, to be marketed as Atebrioz, for the treatment of fibrodysplasia ossificans pro…
    BioSpace · 22d agoApprovalPositive↗ source
  • Merck signs up to $2.13 billion deal with SciBrunch for preclinical KRAS inhibitor SPR2015
    Merck announced it has completed a deal with Chinese biotech SciBrunch Therapeutics, paying $400 million upfront for exclusive global rights to develop, manufacture and commercialize SciBrunch’s pr…
    BioSpace · 22d agoDealPositive↗ source
  • Nonprofits launch ultra-rare immune disease gene therapy Waskyra at $3.25 million price
    Two nonprofit organizations have received FDA approval for a gene therapy that targets an ultra-rare immune disorder. The therapy, called Waskyra, is now being launched with a list price of $3.25…
    Endpoints · 22d agoApprovalNeutral↗ source
  • Merck and Daiichi Sankyo pull accelerated approval request for lung cancer ADC
    Merck and Daiichi Sankyo have voluntarily withdrawn their application for accelerated approval of the antibody-drug conjugate ifinatamab deruxtecan. The FDA indicated that the data package did not…
    BioSpace · 23d agoRegulatoryNegative↗ source
  • Ultragenyx gains FDA approval for Fayuvi, a Sanfilippo syndrome A therapy, easing impact of recent Angelman setback
    Ultragenyx announced that the FDA has approved its drug Fayuvi for treating Sanfilippo syndrome type A, a rare neurodegenerative condition affecting children. The approval marks the company's first…
    BioSpace · 23d agoApprovalPositive↗ source
  • AstraZeneca invests $2 billion for stake in Summit Therapeutics to back its cancer drug
    AstraZeneca announced on Monday that it will invest $2 billion to acquire a minority equity stake in Summit Therapeutics. The investment gives AstraZeneca a slice of the biotech as the companies mo…
    Endpoints · 22d agoDealPositive↗ source
  • Mirum reports Phase 3 success for its acquired hepatitis D therapy
    Mirum Pharmaceuticals announced that its recently acquired chronic hepatitis delta drug met its primary endpoint in a Phase 3 trial. The study tested a once-weekly 300 mg injection, and more than…
    Endpoints · 22d agoPositive readoutPositive↗ source
  • White House seeks data on U.S. manufacturing of 86 essential medicines
    The White House Office of Management and Budget has launched a review of domestic production for a list of 86 medicines deemed essential. The request asks manufacturers to provide information on w…
    Endpoints · 22d agoRegulatoryNeutral↗ source
  • Merck licenses KRAS G12D inhibitor from Tao Hu for $400 million upfront
    Merck has signed a licensing agreement for a KRAS G12D inhibitor, providing an upfront payment of $400 million. The deal follows a 2023 transaction in which the same entrepreneur, synthetic chemis…
    Endpoints · 22d agoDealNeutral↗ source
  • Biopharma chases new immunology targets as Humira and Dupixent set high bar
    Johnson & Johnson, Pfizer, Argenx and several other companies are expanding their immunology pipelines, seeking new targets and improvements to capture part of the market driven by AbbVie’s Humira…
    BioSpace · 23d agoPositive↗ source
  • Adicet Bio reports early CAR-T therapy improves lupus symptoms, plans pivotal trial as shares fall
    Adicet Bio said its off-the-shelf CAR-T cell therapy showed signs of efficacy in a small early-stage trial involving patients with systemic lupus erythematosus. The study reported measurable impro…
    Endpoints · 22d agoPositive readoutNeutral↗ source
  • Scynexis secures $200M+ BARDA contract for investigational antifungal SCY-247
    Scynexis announced a partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) that provides more than $200 million to advance SCY-247, an experimental therapy aimed…
    Endpoints · 22d agoDealPositive↗ source
  • Merck and Daiichi withdraw FDA accelerated approval filing for B7-H3 ADC in small cell lung cancer
    Merck and Daiichi Sankyo announced they have withdrawn their joint FDA accelerated approval filing for a B7-H3 antibody-drug conjugate intended for a subset of small cell lung cancer patients. The…
    Endpoints · 23d agoRegulatoryNegative↗ source
  • Roche halts development of muscle-preserving obesity drug and returns program to Chugai
    Roche announced it is ending work on the experimental muscle-building compound known as GYM329, which had been tested together with a GLP-1 based anti-obesity injection. The decision stops the ong…
    Endpoints · 22d agoNegative↗ source
  • Regenerative medicine requires diagnostics and product characterization beyond stem cell basics
    Stem cell therapies are often portrayed as a single treatment, but they actually vary widely in tissue source, cell passage, viability and delivery methods. Experts say a credible regenerative app…
    BioSpace · 23d agoNeutral↗ source
  • BioSpace report examines factors driving employee engagement in life sciences firms
    BioSpace released a new report titled "What Powers Employee Engagement" that looks at what influences staff morale in the life‑science sector. The study draws on data from the 2027 Best Places to…
    BioSpace · 22d agoNeutral↗ source
  • FDA greenlights AbbVie’s next-generation Parkinson’s drug tavapadon (Juvmo) with expected lower side effects
    The U.S. Food and Drug Administration has approved AbbVie’s new therapy for Parkinson's disease, tavapadon, which will be marketed under the name Juvmo. Tavapadon is a dopamine agonist intended to…
    Endpoints · 24d agoApprovalPositive↗ source
  • Endpoints Weekly returns with new class unveiled at Boston gala
    The newsletter marks the return of Endpoints Weekly, a regular briefing on pharmaceutical industry news. The latest edition introduced the "Endpoints 11" cohort during a gala event in Boston, and…
    Endpoints · 25d agoNeutral↗ source
  • Merck's Welireg receives FDA nod for expanded use with Lenvima in kidney cancer
    Merck announced that its drug Welireg has received FDA approval for use together with Eisai's Lenvima in patients with advanced renal cell carcinoma. The clearance broadens the indication, allowin…
    Endpoints · 25d agoApprovalPositive↗ source
  • Genentech signs $55M upfront deal with AI firm Earendil Labs to develop bispecific cancer antibodies, potential total value over $1.5B
    Genentech announced a partnership with AI‑driven Earendil Labs that includes a $55 million upfront payment and could exceed $1.5 billion when development, regulatory and sales milestones are met. T…
    BioSpace · 26d agoDealPositive↗ source
  • Azalea Therapeutics wins Endpoints 11 award, combines gene editing with CAR-T and raises $82 million
    Azalea Therapeutics was named the winner of the Endpoints 11 2026 competition, highlighting its innovative approach in the biotech space. The company’s platform merges precise gene‑editing techniq…
    Endpoints · 25d agoDealPositive↗ source
  • Carvykti shows 5-year survival in half of multiple myeloma patients in Phase 2 study
    Johnson & Johnson and Legend Biotech reported that 10 of the 20 multiple myeloma patients treated with a single dose of Carvykti remained alive after a median follow‑up of 60.7 months, representing…
    BioSpace · 25d agoPositive readoutPositive↗ source
  • FDA approves Mirum's Atebrioz for ultra-rare disease that hardens muscle and connective tissue
    The U.S. Food and Drug Administration has granted approval for Mirum Pharmaceuticals' new therapy for an ultra-rare genetic disorder that causes muscle and connective tissue to turn into bone. The…
    Endpoints · 25d agoApprovalPositive↗ source