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  • Tarsus Pharma to spend $450M upfront acquiring Alkeus to expand its ophthalmology pipeline
    Tarsus Pharmaceuticals announced it will acquire Alkeus Pharmaceuticals, a Phase 3 biotech focused on a Stargardt disease drug, for an upfront payment of $450 million. The deal is intended to broad…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA approves first drug for type 1 narcolepsy and greenlights mRNA flu vaccine; AstraZeneca and BMS deny merger talks
    The U.S. Food and Drug Administration has granted approval for the first therapy specifically targeting type 1 narcolepsy, marking a milestone for patients with this rare sleep disorder. In a sepa…
    raps · 3mo agoApprovalPositive↗ source
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  • FDA outlines pilot to speed IND submissions for up to 10 drug programs
    The Food and Drug Administration has released details of a new pilot program designed to accelerate the Investigational New Drug (IND) filing process for selected candidates. The agency plans to w…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Teva agrees to $35 million settlement over delayed generic asthma inhalers
    A Massachusetts federal judge approved a settlement involving Teva Pharmaceuticals and several healthcare funds. The agreement sets the payment at $35 million to resolve the dispute. The funds al…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Intellia finds genetic marker linked to liver enzyme spikes in CRISPR ATTR amyloidosis trial
    Intellia Therapeutics announced that analysis of its ongoing CRISPR gene-editing trial for transthyretin (ATTR) amyloidosis has identified a common genetic variant among participants who experience…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Vedanta Biosciences secures $60 million to complete Phase 3 trial of C. difficile microbiome therapy
    Vedanta Biosciences, a Cambridge, MA biotech focused on microbiome therapeutics, announced it has raised $60 million in new financing. The capital will be used to advance its lead candidate target…
    Endpoints · 3mo agoDealPositive↗ source
  • LifeMine Therapeutics secures $263 million to develop safer transplant immunosuppressant
    LifeMine Therapeutics announced it has raised a total of $263 million through two venture financing rounds. The capital, which includes a newly disclosed $75 million Series D round, will be used t…
    Endpoints · 3mo agoDealPositive↗ source
  • FDA approves Moderna flu vaccine
    The U.S. Food and Drug Administration granted approval to Moderna's seasonal flu vaccine, adding another product to the company's portfolio. The approval was announced late Wednesday, after a repo…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Revolution Medicines readies launch of experimental pancreatic cancer drug daraxonrasib as approval decision pending
    Revolution Medicines executives say they are preparing to launch daraxonrasib, an experimental therapy for metastatic pancreatic cancer. The drug is currently awaiting regulatory decisions in the…
    Endpoints · 3mo agoNeutral↗ source
  • FDA says MDUFA VI will prioritize review consistency and domestic focus over faster timelines
    FDA officials explained that the next Medical Device User Fee Amendments, known as MDUFA VI, will aim to improve consistency in the review process. The agency said the new framework will emphasize…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Sarepta delays Elevidys study readout while Emergent cuts 90 jobs
    Sarepta Therapeutics told investors that the readout for its non‑ambulatory Elevidys trial will not be available by the end of the year as previously expected. The company indicated the delay durin…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Braveheart Bio raises $383 million in Nasdaq IPO to advance Hengrui cardiovascular drug to Phase 3
    Braveheart Bio, a U.S. biotech spun out of China’s Hengrui Pharmaceuticals, completed an initial public offering on the Nasdaq. The offering generated about $383 million in gross proceeds, providi…
    Endpoints · 3mo agoDealPositive↗ source
  • Medline recalls Hudson RCI neonatal heated wire breathing circuits over connector overheating risk
    Medline Industries announced a nationwide recall of its Hudson RCI Neonatal/Infant Heated Wire Breathing Circuits. The recall was triggered after the company received reports of sporadic failures i…
    fda medwatch · 3mo agoRegulatoryNegative↗ source
  • EMA launches consultation to streamline nonclinical development for life-threatening diseases
    EMA announced a public consultation on proposals to accelerate the nonclinical phase of drug development for diseases that are severely debilitating or life‑threatening. The agency aims to reduce…
    raps · 3mo agoRegulatoryNeutral↗ source
  • Merck KGaA to receive up to €40 million in US tariff refunds for life science business through 2026
    Merck KGaA announced that it expects to receive tariff refunds for its life‑science division after a US Supreme Court ruling. The company estimates the refunds will total roughly €40 million and w…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • Centene reports strong enrollment growth but modest scale for its ICHRA offering
    Centene's chief executive Sarah London said the company's individual coverage health reimbursement arrangement (ICHRA) business is experiencing a strong enrollment growth rate, though the total num…
    Endpoints · 3mo agoEarningsPositive↗ source
  • Eli Lilly Q2 revenue hits $23 billion, topping forecasts as tirzepatide drives two-thirds of sales
    Eli Lilly reported second-quarter revenue of $23 billion, roughly $3 billion above analysts' estimates. Tirzepatide contributed about 64% of the total, highlighting its central role in the company…
    Endpoints · 3mo agoEarningsPositive↗ source
  • FDA approves Takeda's orexin drug for narcolepsy type 1
    Takeda has received FDA approval for its orexin agonist intended to treat narcolepsy type 1. The decision ends a closely watched commercial race to bring an orexin-based therapy to market. With a…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Novo Nordisk looks to bolt-on acquisitions as pipeline setbacks mount
    Novo Nordisk CEO Maziar Mike Doustdar said on a media call that the pharma industry is tough for those who dislike setbacks and failure. He highlighted recent disappointments in the company's pipe…
    Endpoints · 3mo agoDealNeutral↗ source
  • Attovia Therapeutics raises $289 million in IPO, adding third I&I drug to market debut
    Attovia Therapeutics, a biotech focused on immunology and inflammation, completed an initial public offering that raised about $289 million. The funds will support the development of three I&I dru…
    Endpoints · 3mo agoDealPositive↗ source
  • Victory Medical Center Pharmacy recalls glutathione vials over high endotoxin levels
    Victory Medical Center Pharmacy in Austin announced a voluntary recall of specific lots of its compounded glutathione 200 mg/mL multi‑dose vials. Testing at the pharmacy detected elevated bacteria…
    fda medwatch · 3mo agoCRLNegative↗ source
  • Gilead's HIV prevention shot Yeztugo posts $232 million Q2 sales, beating forecasts
    Gilead reported that its biannual injectable for HIV pre‑exposure prophylaxis, Yeztugo, generated $232 million in revenue during the second quarter. This figure exceeds analysts' consensus estimat…
    Endpoints · 3mo agoEarningsPositive↗ source
  • Arrowhead Pharma to pay $215 million for PRV in its latest acquisition
    Arrowhead Pharmaceuticals disclosed in an SEC filing that it will acquire PRV for $215 million, marking the highest price tag for a deal this year. The purchase aligns with Arrowhead's strategy of…
    Endpoints · 3mo agoDealNeutral↗ source
  • Expedition Therapeutics raises $115M Series B for China-sourced COPD candidate
    Expedition Therapeutics, a US biotech, announced a $115 million Series B financing round. The capital will be used to advance its COPD drug candidate that is being developed from a China-sourced p…
    Endpoints · 3mo agoDealPositive↗ source
  • Fresenius Kabi recalls one lot of Morphine Sulfate Injection after labeling error mixes Dilaudid syringes
    Fresenius Kabi announced a voluntary recall of a single lot of its Morphine Sulfate Injection USP, Simplist 2 mg/1 mL product. The recall stems from a labeling mistake where the MicroVault contain…
    fda medwatch · 3mo agoCRLNegative↗ source