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1,104 stories matching this filter · ← front page

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  • Bristol Myers reports Phase 3 data showing mezigdomide extends survival in relapsed multiple myeloma
    Bristol Myers Squibb presented Phase 3 results for its experimental multiple myeloma drug mezigdomide at the American Society of Clinical Oncology meeting. The study evaluated mezigdomide combined…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Pfizer partners with China's Innovent Biologics on $10 billion cancer drug collaboration
    Pfizer announced a major partnership with Chinese biotech Innovent Biologics, valued at over $10 billion, to develop cancer therapies. The agreement covers up to 12 antibody-based candidates, incl…
    BioPharma Dive · 3mo agoDealPositive↗ source
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fda recalls67
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Infectious Disease444
  • Merck touts promising ADC sacituzumab tirumotecan as potential cornerstone therapy at ASCO
    Merck highlighted a new antibody-drug conjugate, sacituzumab tirumotecan (sac-TMT), licensed from Chinese biotech Kelun-Biotech, at the ASCO meeting. The company said early clinical data have give…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • Replimune to file third FDA application for RP1 cancer therapy after productive talks
    Replimune announced it will submit a third marketing application for its experimental cancer therapy RP1, following what the company described as productive discussions with the Food and Drug Admin…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Allogene CEO David Chang to step down as Agios drug misses mid-stage trial results
    Allogene announced that its chief executive, co‑founder David Chang, will leave the role after an eight‑year tenure. Chang, who previously worked at Kite Pharma, will remain on the company’s board…
    BioPharma Dive · 3mo agoNegative readoutNeutral↗ source
  • Former FDA official says leadership turnover won’t derail push for faster US drug trials
    The Food and Drug Administration has faced a wave of leadership changes this year, creating uncertainty about its ability to keep drug development moving quickly. Industry leaders and regulators, h…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • GSK and Ionis report functional cure in 20% of hepatitis B patients with bepirovirsen in early trials
    GSK and Ionis disclosed results from two clinical studies of their RNA‑based injection, bepirovirsen, aimed at achieving a functional cure for chronic hepatitis B. In both trials about one‑fifth o…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • CVS adds Lilly’s Foundayo and Zepbound to formularies, leveling GLP-1 market with Novo
    CVS Caremark announced it will place Eli Lilly’s new oral GLP-1 drug Foundayo on its formulary starting June 1 and will restore the injectable Zepbound as a preferred option from Oct 1. The change…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • Mentari Therapeutics to go public via reverse merger with InMed, raising $290 million for migraine antibody programs
    Mentari Therapeutics, a spinout of Paragon, announced a reverse merger with InMed Pharmaceuticals that will take the company public under the Mentari name. The deal has received board approval fro…
    BioPharma Dive · 3mo agoDealPositive↗ source
  • BioMarin's BMN-401 fails key endpoint in ENPP1 deficiency Phase 3 trial
    An experimental therapy, BMN 401, was tested in a Phase 3 study for ENPP1 deficiency, a rare disease. The drug missed one of its two co-primary endpoints, a result that regulators consider critical…
    BioPharma Dive · 3mo agoNegative readoutNegative↗ source
  • Relay Therapeutics' zovegalisib shows 60% response in mid‑stage trial for rare vascular anomalies
    Relay Therapeutics reported early data from a phase 2 trial of its experimental drug zovegalisib in patients with vascular anomalies, a group of rare disorders characterized by abnormal blood vesse…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • FDA approves AstraZeneca’s novel hypertension pill Baxfendy
    The U.S. Food and Drug Administration has cleared AstraZeneca’s new hypertension medication, Baxfendy, marking the first approval of a drug that works by inhibiting a blood‑pressure‑raising enzyme.…
    BioPharma Dive · 3mo agoApprovalPositive↗ source
  • Merck's China-sourced ADC shows survival benefit in Phase 3 endometrial cancer trial
    Merck & Co., in partnership with Chinese biotech Kelun-Biotech, reported that its experimental antibody-drug conjugate sacituzumab tirumotecan (Sac-TMT) met its primary endpoint in a global Phase 3…
    BioPharma Dive · 3mo agoPositive readoutPositive↗ source
  • FDA leadership overhaul follows firing of acting CDER director; 20 deaths linked to Amgen’s Tavneos in Japan
    The FDA announced another leadership change, removing acting directors of its two main drug review centers. Tracy Beth Høeg, acting head of the Center for Drug Evaluation and Research (CDER), poste…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
  • Pharma firms turn to outsourcing to boost value of aging drug portfolios
    For many years pharma companies treated legacy brands as low-maintenance cash generators, focusing only on steady but declining revenue once patents expired. With the largest patent cliff in histo…
    BioPharma Dive · 3mo agoPositive↗ source
  • Regeneron immunotherapy combo comes up short in melanoma trial
    A two-drug regimen of Regeneron’s fianlimab and Libtayo didn’t significantly outperform Keytruda in a late-stage study, a finding that surprised Wall Street analysts and wiped out billions in marke…
    BioPharma Dive · 3mo agoRegulatoryNeutral↗ source
  • Preoperative intravesical mitomycin C cuts NMIBC recurrence risk by 77% over five years
    A recent study evaluated giving two doses of intravesical mitomycin C before transurethral resection of bladder tumor (TURBT) in patients with non‑muscle‑invasive bladder cancer (NMIBC). Compared…
    onclive · 3mo agoPositive readoutPositive↗ source
  • High TMB, GBD and PD-L1 Levels Linked to Better Response in Neoadjuvant Gem-iDRS or Cetrelimab Trial for Bladder Cancer
    The SunRISe-4 trial evaluated neoadjuvant gemcitabine‑based immunotherapy with or without cetrelimab in patients with muscle‑invasive bladder cancer. A biomarker sub‑analysis showed that patients…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Expert reviews real-world data on BCG retreatment after failure in non-muscle-invasive bladder cancer
    Dr Joshua J. Meeks, MD, PhD, provided an overview of a real-world study that examined the use of BCG retreatment in patients with non‑muscle‑invasive bladder cancer (NMIBC) who had previously faile…
    onclive · 3mo agoNeutral↗ source
  • Multidisciplinary quality program shown to cut side effects of androgen deprivation therapy in prostate cancer
    Dr Hafron discussed a recent study that evaluated a multidisciplinary quality initiative aimed at reducing adverse events linked to androgen deprivation therapy for prostate cancer. The program co…
    onclive · 3mo agoPositive readoutPositive↗ source
  • FDA approves trastuzumab deruxtecan for early-stage HER2-positive breast cancer
    The U.S. Food and Drug Administration has granted approval for trastuzumab deruxtecan (T‑DXd) as a treatment option in both the adjuvant and neoadjuvant settings for certain patients with early-sta…
    onclive · 3mo agoApprovalPositive↗ source
  • Sun Pharma’s $12 billion Organon deal signals global push but India still faces R&D hurdles
    Sun Pharma is close to completing a nearly $12 billion purchase of Organon, which would lift the Indian group into the world’s top‑25 pharmaceutical companies and expand its footprint to about 150…
    BioPharma Dive · 3mo agoDealNeutral↗ source
  • FDA approves adjuvant atezolizumab for MRD-positive muscle-invasive bladder cancer, says Dr. Hafron
    The U.S. Food and Drug Administration has granted approval for adjuvant atezolizumab in patients with MRD-positive muscle-invasive bladder cancer. The decision expands the use of the immunotherapy…
    onclive · 3mo agoApprovalPositive↗ source
  • Durvalumab combined with BCG cuts recurrence risk by 32% in phase 3 trial for high-risk non-muscle-invasive bladder cancer
    A phase 3 study called POTOMAC tested durvalumab together with BCG induction and maintenance against BCG alone in patients who had not previously received BCG and who have high-risk non-muscle-inva…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Darolutamide with ADT cuts death risk by half in metastatic hormone‑sensitive prostate cancer
    A recent study evaluated darolutamide combined with androgen deprivation therapy in patients with metastatic hormone‑sensitive prostate cancer. The trial reported a 50% reduction in the risk of dea…
    onclive · 3mo agoPositive readoutPositive↗ source