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  • FDA mandates label update for all GLP-1 drugs to warn of rare eye disease risk
    The FDA issued a class‑wide labeling requirement for all approved GLP‑1 receptor agonists, adding a warning about non‑arteritic anterior ischemic optic neuropathy (NAION), a rare eye condition that…
    BioSpace · 19h agoRegulatoryNeutral↗ source
  • Democrats’ Midterm Wins Boost Hospital Prospects as CVS Breakup Looms
    Voters gave Democrats a decisive edge in the recent midterm elections, reshaping the political landscape for the coming year. The shift is expected to favor the hospital sector, which stands to gai…
    STAT · 19h agoPositive↗ source
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  • Delix Therapeutics secures $100 million Series C to advance psychedelic pipeline
    Delix Therapeutics announced it has closed a $100 million Series C financing round. The capital will be used to accelerate development of its pipeline of psychedelic and neuroplastogen candidates…
    Endpoints · 21h agoDealPositive↗ source
  • Boehringer Ingelheim to seek approval for obesity injection survodutide after trial shows no added cardiovascular risk
    Boehringer Ingelheim announced it will file for regulatory approval of its investigational GLP-1 based obesity injection, survodutide, in the coming year. The move follows a phase 3 trial that dem…
    Endpoints · 21h agoApprovalNeutral↗ source
  • Compass Pathways to file FDA approval for psilocybin depression therapy within weeks
    Compass Pathways announced it will complete its FDA filing for the psilocybin‑based depression treatment COMP360 in the next two weeks. The company expects the rolling submission to enable a drug…
    BioSpace · 22h agoRegulatoryNeutral↗ source
  • J&J/Protagonist’s oral Icotyde shows Phase 3 benefit in psoriatic arthritis but trails AbbVie’s Skyrizi
    A Phase 3 study of Johnson & Johnson and Protagonist Therapeutics’ oral IL‑23 receptor antagonist Icotyde met its primary endpoint, demonstrating improvement in psoriatic arthritis symptoms. In th…
    BioSpace · 22h agoPositive readoutNeutral↗ source
  • Merck's efinopegdutide shows strong MASH resolution in phase 2b trial
    Merck & Co. reported results from a phase 2b trial (MK-6024-013) evaluating efinopegdutide, a GLP-1 and glucagon receptor co-agonist, in patients with metabolic dysfunction-associated steatohepatit…
    Fierce Biotech · 22h agoPositive readoutPositive↗ source
  • Eli Lilly to pursue FDA approval for obesity drug in obstructive sleep apnea after positive Phase 3 trial
    Eli Lilly announced that it will seek regulatory approval for its obesity medication as a treatment for obstructive sleep apnea, following a successful Phase 3 study. The trial showed positive res…
    Endpoints · 23h agoPositive readoutPositive↗ source
  • Lilly's oral GLP-1 pill Foundayo reduces sleep apnea events in late-stage trials
    In two late-stage trials, Eli Lilly’s oral GLP‑1 pill Foundayo lowered the apnea‑hypopnea index by an average of 17.8 events per hour, compared with a 4.5‑event reduction for patients on placebo.…
    STAT · 23h agoPositive readoutPositive↗ source
  • Novo’s IL-6 inhibitor ziltivekimab may target milder cardio-renal patients after Phase 3 miss
    At the American Heart Association meeting, investigators discussed new data on Novo Nordisk’s IL-6 inhibitor ziltivekimab, suggesting it could be studied in patients with less severe cardiovascular…
    BioSpace · 23h agoNegative readoutNeutral↗ source
  • Marea Therapeutics' triglyceride drug lowers levels without raising blood sugar in high-risk patients
    Marea Therapeutics reported new data on its investigational lipid‑lowering medicine, showing it can further reduce triglyceride levels in patients with dangerously high blood concentrations. The s…
    Endpoints · 23h agoPositive readoutPositive↗ source
  • Argenx to acquire macrocycle biotech Unnatural Products in up to $1.15 billion deal
    Argenx announced Monday it will acquire Unnatural Products, a biotech focused on macrocycle therapeutics that began as a garage startup. The transaction is structured as an up-to-$1.15 billion dea…
    Endpoints · 1d agoDealNeutral↗ source
  • Democrats weigh limits of health-care reforms after midterm win
    In the days after their sweeping midterm victories, House and Senate Democrats are debating the scope of possible health-care actions. Party leaders agree on rolling back the Medicaid cuts impleme…
    STAT · 1d agoRegulatoryNeutral↗ source
  • Global liver experts agree on definition of acute-on-chronic liver failure
    Liver doctors from many countries have reached a common definition for acute-on-chronic liver failure, a serious complication that occurs when an existing liver disease is suddenly worsened by an a…
    STAT · 1d agoPositive↗ source
  • CVS split into two entities fails to address core issues in pharmacy benefit management
    CVS Health is one of the largest U.S. companies, serving hundreds of millions of Americans and generating about $400 billion in annual revenue. It touches nearly every step of the drug supply chain…
    STAT · 1d agoNegative↗ source
  • Zura Bio halts hidradenitis suppurativa program after tibulizumab fails phase 2 trial
    Zura Bio announced it is ending development of tibulizumab for hidradenitis suppurativa after the drug did not meet the primary endpoint in a phase 2 study. The trial, called Tibushield, compared t…
    Fierce Biotech · 1d agoNegative readoutNegative↗ source
  • Vir Biotechnology's Phase 3 Trial Shows Primary Endpoint Success in Chronic Hepatitis Delta
    Vir Biotechnology reported that its phase 3 Eclipse 1 trial in chronic hepatitis delta met the primary endpoint. At week 48, 44% of patients who began treatment immediately showed undetectable HDV…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • Valneva's Shigella vaccine cuts infection rates in phase 2 trial
    Valneva reported that its Shigella vaccine reduced the number of intestinal infections in a phase 2 controlled human infection model study conducted in the United States. The trial enrolled 120 he…
    Fierce Biotech · 1d agoPositive readoutPositive↗ source
  • FDA cuts required analytical tests for emergency-use diagnostic devices in new guidance
    On 9 November 2026 the U.S. Food and Drug Administration released final guidance aimed at simplifying validation of in-vitro diagnostic devices used in public-health emergencies. The document outli…
    raps · 1d agoRegulatoryPositive↗ source
  • ARPA-H teams meet FDA within two months of launching autonomous clinical AI program
    Multiple teams in ARPA-H's Advocate program, which focuses on autonomous clinical AI tools, have already held an initial informational meeting with the FDA. The meeting took place less than two mo…
    Endpoints · 17h agoRegulatoryNeutral↗ source
  • Trump's MFN drug pricing agreements complicate new drug launches
    President Donald Trump announced nine new agreements with drug manufacturers on Aug. 31, extending the “most favored nation” (MFN) pricing framework. Under MFN, U.S. prices for participating drugs…
    Endpoints · 17h agoRegulatoryNegative↗ source
  • FDA requires GLP-1 drug labels to include warning about rare eye disease
    The FDA has issued a directive to manufacturers of GLP-1 therapies, instructing them to revise product labeling. The label change must highlight an increased risk of a rare ocular condition that c…
    Endpoints · 17h agoRegulatoryNeutral↗ source
  • Phase 3 trial shows Zealand-Boehringer obesity drug survodutide does not raise cardiovascular death risk
    The Phase 3 SYNCHRONIZE-CVOT study found that survodutide, the joint obesity therapy from Zealand and Boehringer Ingelheim, was non‑inferior to placebo for cardiovascular death, indicating no added…
    BioSpace · 19h agoPositive readoutNeutral↗ source
  • American Heart Association meeting reports neutral outcomes for inflammation and Lp(a) trials
    The American Heart Association's scientific sessions in Chicago highlighted a theme of neutral findings across cardiovascular research. Two high profile trials, ZEUS targeting inflammation and HOR…
    STAT · 20h agoNeutral↗ source
  • Heron sells assets to CorMedix for $145M upfront, Faeth shares plunge
    Heron Therapeutics announced it has sold a portfolio of assets to CorMedix for an upfront cash payment of $145 million. The transaction gives CorMedix additional product candidates and expands its…
    Endpoints · 21h agoDealNeutral↗ source