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  • 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
  • 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
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  • 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
  • Eli Lilly’s Mounjaro and Merck’s oral PCSK9 inhibitor win FDA nod amid string of cardiovascular trial setbacks
    The cardiovascular drug development landscape entered the American Heart Association’s Scientific Sessions with a mix of optimism and disappointment. Recent months have seen several late‑stage tria…
    BioSpace · 18h agoRegulatoryNeutral↗ source
  • Neurosterix raises $105M Series B to advance oral M4 schizophrenia drug and adds former Karuna leaders
    Neurosterix, a spinout from Addex Therapeutics, announced a $105 million Series B financing. The round was led by RTW Investments with participation from GV, Janus Henderson Investors and others. A…
    BioSpace · 20h agoDealPositive↗ source
  • Pfizer secures up to $1.5 billion from Blackstone to fund berobenatide obesity drug development
    Pfizer announced a financing arrangement with Blackstone Life Sciences that could provide up to $1.5 billion to support the development of berobenatide, an obesity drug acquired from Metsera. The…
    BioSpace · 23h agoDealPositive↗ 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
  • Eros Apothecary recalls Candy Power For Man honey supplement after undisclosed tadalafil found
    Eros Apothecary of Indio, California announced a recall of its Candy Power For Man Organic Honey dietary supplement after FDA testing revealed the presence of undeclared tadalafil. Tadalafil is th…
    fda recalls · 20h agoCRLNegative↗ 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 · 20h 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 · 21h 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
  • BMS to consolidate R&D under single leader as chief research officer exits
    Bristol Myers Squibb announced a reorganization of its research and development unit, merging early research and discovery with drug development under a single leader. Chief Research Officer Rober…
    BioSpace · 23h agoNeutral↗ source
  • Experts say predictive analytics and distributed manufacturing could curb drug shortages
    BioSpace Insights hosted a podcast episode featuring Christina Smolke, co-founder and CEO of Antheia, and Kyle Pudenz, senior vice president of data and AI product at Cencora. The conversation focu…
    BioSpace · 1d agoPositive↗ 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
  • Biopharma layoffs rise YoY in October but overall trend points down for 2026
    October marked the first time this year that both the number of biotech and pharma firms announcing workforce cuts and the total employees affected rose compared with 2025. Three additional employ…
    BioSpace · 1d agoLayoffsNegative↗ 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
  • 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
  • Game Changer Products recalls 10 Day Forecast capsules after FDA finds undeclared sildenafil and acetaminophen
    Game Changer Products LLC announced a voluntary nationwide recall of its 10 Day Forecast capsules, a dietary supplement marketed at 3200 mg. The FDA’s analysis detected the presence of undeclared…
    fda recalls · 20h agoCRLNegative↗ source
  • FDA shelves Commissioner’s National Priority Voucher program ahead of Heidi Overton confirmation vote
    The Food and Drug Administration has halted the Commissioner’s National Priority Voucher (CNPV) program as the Senate prepares to vote on Heidi Overton’s nomination as the agency’s next commissione…
    BioSpace · 21h agoRegulatoryNeutral↗ 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