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  • 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 · 24d agoNeutral↗ source
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  • 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
  • Adicet Bio's off-the-shelf CAR-T therapy shows lupus remission in early Phase 1 trial
    Adicet Bio reported that its off-the-shelf CAR-T product prula-cel induced remission in more than half of lupus patients enrolled in a small Phase 1 study. One year after a single infusion, 12 of…
    Fierce Biotech · 25d agoPositive readoutPositive↗ 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
  • Novo signs $1.3 billion deal with Nanexa to add long-acting injectables for obesity and diabetes
    Novo has entered a licensing agreement with Nanexa, valued at about 1.17 billion euros, to use Nanexa’s PharmaShell platform for its obesity and type‑2 diabetes medicines. The PharmaShell technolo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Genentech signs $1.5 billion bispecific antibody deal with Earendil Labs
    Genentech, Roche's US subsidiary, announced a licensing agreement with Earendil Labs to discover and develop multiple bispecific antibodies aimed at oncology. The agreement provides a $55 million…
    Fierce Biotech · 26d agoDealPositive↗ 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
  • Experts say expanding beyond rare disease markets can make ultra-rare therapies financially viable
    The piece highlights that investment in ultra‑rare disease treatments remains limited, and experts argue the answer is not to focus solely on the rare condition itself. They propose that drugmaker…
    Endpoints · 25d agoPositive↗ source
  • NewLimit raises $682M to pursue new class of anti-aging drugs
    NewLimit, a biotech startup based in South San Francisco, announced it secured $682 million in funding. The round was led by venture firms including Kleiner Perkins, Founders Fund, Dimension Capit…
    Endpoints · 25d agoDealPositive↗ source
  • SonoThera secures $186 million to advance non-viral gene-therapy platform
    SonoThera, the winner of the Endpoints 11 2026 competition, announced a fresh financing round to push its non-viral gene-therapy technology forward. The company raised a total of $186 million, wit…
    Endpoints · 25d agoDealPositive↗ source
  • ADARx prices $446.3 million Nasdaq debut, boosting biotech IPO wave
    ADARx Pharmaceuticals, a RNA interference focused biotech, announced pricing of its initial public offering at $446.3 million on Nasdaq. The offering was upsized, reflecting strong investor demand…
    Endpoints · 25d agoDealNeutral↗ source
  • ADARx upsizes Nasdaq IPO to $446M as City Therapeutics eyes public listing
    ADARx Pharmaceuticals, a San Diego-based RNA biotech, completed a Nasdaq initial public offering this morning, selling 26.3 million shares at $17 each. The offering generated gross proceeds of abo…
    Fierce Biotech · 26d agoDealPositive↗ source
  • Pharma groups urge FDA to clarify criteria for approving drugs based on a single pivotal trial
    Pharmaceutical companies and industry associations are asking the U.S. Food and Drug Administration for more detailed guidance on when a single pivotal clinical trial, supported by additional confi…
    Endpoints · 25d agoRegulatoryNeutral↗ source
  • Anew Labs, ByteDance’s biotech spinout, raises $290M to build a China AI bio rival
    Anew Labs, a biotech spinout from ByteDance, announced it has secured $290 million in funding. The capital came from a mix of Chinese investors such as HSG, IDG Capital and Hillhouse Investment, a…
    Endpoints · 25d agoDealPositive↗ source
  • Vivodyne’s Human Tissue Factory Wins Endpoints 11 2026, Promising Faster Drug Testing
    Vivodyne was announced as the winner of the Endpoints 11 2026 competition for its human tissue factory technology. The platform creates human tissue constructs that can be used in preclinical drug…
    Endpoints · 25d agoPositive↗ source
  • Lundbeck plans US headquarters move to Boston to boost neuroscience R&D
    Lundbeck, a Danish pharmaceutical company focused on neuroscience, announced it will relocate its U.S. operations to Boston. The move is part of a broader strategy to concentrate R&D on increasing…
    Fierce Biotech · 25d agoNeutral↗ source
  • Boston Scientific recalls Imager II angiographic catheters over tip detachment risk
    Boston Scientific has issued a recall of its Imager II Angiographic Catheters after a manufacturing problem that can cause the catheter tip to detach during use. The FDA classified the recall as t…
    fda medwatch · 26d agoCRLNegative↗ source
  • Jury awards Nektar $90 million in lawsuit against Eli Lilly over licensing dispute
    A federal jury in a US District Court awarded Nektar Therapeutics $90 million after finding Eli Lilly breached a licensing agreement. The verdict ends a dispute that began when the parties' licens…
    Endpoints · 25d agoPositive↗ source
  • NIH deputy director Nicole Kleinstreuer leads push to cut animal testing with new policies
    NIH has spent the past 18 months accelerating policies aimed at reducing the use of animals in research. The effort is being directed by Dr. Nicole Kleinstreuer, the agency’s deputy director for p…
    Fierce Biotech · 25d agoRegulatoryPositive↗ source
  • Medici wins Endpoints 2026 award, touts personalized cancer therapy
    Medici was announced as the winner of the Endpoints 2026 competition. The company said its approach focuses on tailoring cancer treatments to individual patients. The award highlights growing int…
    Endpoints · 25d agoPositive↗ source
  • Endpoints 11 showcases top biotech startups, signaling renewed optimism and funding
    The Endpoints 11 awards highlight the most promising biotech startups of 2026, offering a snapshot of emerging trends in the sector. According to the summary, the awards illustrate that biotech ap…
    Endpoints · 25d agoPositive↗ source
  • Indivior ends Addex PAM collaboration as it prepares for Supernus merger
    Indivior Pharmaceuticals has terminated its long‑standing partnership with Addex Therapeutics that focused on developing positive allosteric modulators (PAMs) for addiction treatment. The collabor…
    Fierce Biotech · 25d agoDealNeutral↗ source
  • Kali Therapeutics pivots from Chinese drug acquisitions to focus on its own growing pipeline
    Kali Therapeutics, the winner of the Endpoints 11 2026 competition, initially explored the possibility of purchasing drug candidates from China. The company ultimately chose to rely on its own res…
    Endpoints · 25d agoPositive↗ source
  • Stipple Bio wins Endpoints 2026 award for precision pancreatic cancer therapy
    Stipple Bio was announced as the winner of the Endpoints 2026 competition, recognized for its work in precision medicine. The company’s approach focuses on developing targeted treatments for pancr…
    Endpoints · 25d agoPositive↗ source