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  • Swiss biotech Windward Bio raises $175 million in IPO to fund lung-drug development and test Tezspire competitor
    Windward Bio, a Swiss immune‑drug developer, completed a $175 million initial public offering, selling about 10.3 million shares at $17 each. The company began trading on the exchange under the tic…
    BioPharma Dive · 11h agoDealPositive↗ source
  • Virtuoso Surgical receives FDA De Novo clearance for robotic bladder lesion removal system
    Virtuoso Surgical's Virtuoso Endoscopy System received FDA De Novo authorization, marking the first device in a new classification for electromechanical surgical technologies that use robotic instr…
    Fierce Biotech · 9h agoApprovalPositive↗ source
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  • Regeneron posts positive phase 2 data for baloncibart in nervous system disorder, eyes pivotal trial
    Regeneron has posted positive phase 2 data on baloncibart in postural orthostatic tachycardia syndrome, teeing the biotech up to start a potentially pivotal trial in the first half of 2027.
    Fierce Biotech · 9h agoNeutral↗ source
  • Gubra CEO gets the quick hook; Ex-HHS official Brett Giroir takes over at cancer biotech
    → AbbVie and Boehringer Ingelheim’s Danish obesity partner Gubra is going with a co-CEO arrangement after the abrupt departure of Markus Rohrwild. Endpoints News just spoke with Rohrwild last month…
    Endpoints · 1h ago↗ source
  • Sanofi-backed Windward hits $225M IPO goal to advance respiratory drugs from China
    Windward Bio’s IPO has blown to exactly the spot the Swiss biotech had been aiming for, bringing in $225 million to fund a pair of respiratory drugs licensed from China.
    Fierce Biotech · 9h ago↗ source
  • FDA faces over 1,000 vacant positions as staffing shortage strains pharma oversight
    The FDA currently has more than a thousand open jobs, reflecting a deep staffing shortfall that began after a large wave of departures last year. The agency lost 1,343 employees at its CBER and CD…
    BioPharma Dive · 22h agoNegative↗ source
  • FDA’s fast-track voucher program appears to be discontinued, report finds
    A recent report indicates that the FDA’s expedited voucher program, launched to speed approval of certain drugs, has not issued any new vouchers in the six months since former commissioner Marty Ma…
    Endpoints · 17h agoRegulatoryNegative↗ source
  • EnGene reports improved bladder cancer data after May setback
    EnGene, a biotech developing a bladder cancer therapy, released new data that appear more encouraging than the results disclosed in May. The May data had shown limited durability, causing a sharp…
    Endpoints · 20h agoPositive readoutPositive↗ source
  • BioNTech spends $205 million to buy Scholar Rock’s FDA priority-review voucher as J&J scales back in Norway
    BioNTech announced it has purchased an FDA priority review voucher from Scholar Rock for $205 million. The voucher, which can be used to accelerate the regulatory review of a future drug, was origi…
    Endpoints · 21h agoDealPositive↗ source
  • Merck KGaA records €366 million impairment on Lonza CDMO sale as PharmaLogic acquires Lantheus' manufacturing unit
    Merck KGaA disclosed a €366 million ($405.8 million) impairment loss tied to the sale of its contract development and manufacturing organization (CDMO) business to Lonza, according to its third‑qua…
    Endpoints · 22h agoDealNegative↗ source
  • Parker Institute chief urges renewed focus on cancer immunotherapy after mixed results from Revolution Medicines' drug
    Ira Mellman, who leads research at the Parker Institute for Cancer Immunotherapy, said on Sept. 16, 2026 that he felt disappointment and frustration as the industry celebrated Revolution Medicines'…
    Endpoints · 23h agoNegative↗ source
  • Blackstone pledges up to $1.5 billion to fund Pfizer's obesity drug berobenatide development
    Blackstone Life Sciences has agreed to provide up to $1.5 billion to support the research and development of Pfizer's obesity candidate, berobenatide, which originated from the former Metsera progr…
    Endpoints · 1d agoDealPositive↗ source
  • BMS consolidates R&D under chief medical officer Cristian Massacesi as chief research officer Robert Plenge exits
    Bristol Myers Squibb announced that starting Jan. 1, its chief medical officer and head of development, Cristian Massacesi, will lead a newly combined research and development unit, merging previou…
    Fierce Biotech · 1d agoNeutral↗ source
  • Neurosterix secures $105M Series B to launch phase 2 schizophrenia trial
    Addex Therapeutics' spinout Neurosterix announced a $105 million Series B financing to fund its upcoming phase 2 trial of NTX-253 for schizophrenia. The round was led by a syndicate of leading lif…
    Fierce Biotech · 1d agoDealPositive↗ source
  • FDA pauses voucher program as Eli Lilly's GLP-1 weight-loss drug cleared in China; experts see AI aid for device regulation
    The U.S. Food and Drug Administration announced it is shelving the commissioner's voucher program, effectively pausing the incentive that speeds up review of certain products. Eli Lilly secured ap…
    raps · 1d agoRegulatoryNeutral↗ source
  • EMA seeks industry input on draft guideline for biomarker-guided therapy approvals
    The European Medicines Agency has published a draft guideline that details the information required for approving medicines that use biomarkers to select patients. The agency is opening a public c…
    raps · 1d agoRegulatoryNeutral↗ source
  • FDA asks industry for feedback on improving patient-level real-world data submissions
    The FDA announced a request for comments on ways to address challenges associated with submitting patient-level real-world data and evidence in drug and biologic applications. The agency is seekin…
    raps · 1d agoRegulatoryNeutral↗ source
  • Google launches Gemini AI platform for healthcare
    Google has introduced Gemini, a new artificial‑intelligence platform aimed at the healthcare sector. The rollout marks the company's latest move into health‑focused technology. The firm already su…
    Endpoints · 17h agoPositive↗ source
  • HHS rolls out new funding and research programs for psychedelics, with a focus on ibogaine
    HHS announced Thursday a series of new funding allocations and research initiatives aimed at advancing the study of psychedelic compounds. The effort follows President Donald Trump's spring execut…
    Endpoints · 16h agoRegulatoryPositive↗ source
  • Rezera delays $200M IPO amid weak market conditions
    Rezera, a biotech developing drugs for cardiovascular and inflammatory diseases, announced that it will not proceed with its planned initial public offering that had been scheduled for Friday. The…
    Endpoints · 17h agoDealNegative↗ source
  • Bristol Myers appoints Cristian Massacesi as head of R&D as Robert Plenge exits
    Bristol Myers Squibb announced a reorganization of its research and development organization, merging the research and development units under a single leader. Cristian Massacesi, currently chief…
    BioPharma Dive · 21h agoNeutral↗ source
  • Bristol Myers shifts R&D leadership to chief medical officer Cristian Massacesi as research head Robert Plenge departs
    Bristol Myers Squibb announced a reorganization of its research and development structure. The company said chief medical officer and head of development Cristian Massacesi will assume the duties…
    Endpoints · 1d agoNeutral↗ source
  • FDA suspends National Priority Voucher pilot and pauses release of complete response letters
    The Food and Drug Administration has quietly ended the National Priority Voucher pilot, a program that was designed to speed the review of certain drug candidates. In addition, the agency appears…
    Fierce Biotech · 1d agoRegulatoryNeutral↗ source
  • Vor Bio pays RemeGen $10 million for rights to long-acting autoimmune drug candidate RC298
    Vor Bio announced a licensing agreement with RemeGen, paying $10 million upfront in cash and issuing warrants valued at about $46 million for rights to RC298 outside Greater China. RC298 is a long…
    Fierce Biotech · 1d agoDealPositive↗ source
  • Kyverna pauses development of next-gen autoimmune CAR-T KYV-102 to focus on neurologic miv-cel program
    Kyverna Therapeutics announced it is halting work on its next-generation CD19 CAR-T candidate KYV-102, which had been positioned as a follow-up to its lead autoimmune CAR-T miv-cel. KYV-102 was de…
    Fierce Biotech · 1d agoNegative↗ source