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  • Bristol Myers Squibb signs up to $15.2 billion partnership with China's Hengrui Pharma
    Bristol Myers Squibb announced a licensing partnership with China's Hengrui Pharma covering more than a dozen early-stage drug programs. The agreement includes a $600 million upfront payment to He…
    STAT · 4mo agoDealPositive↗ source
  • FDA chief Marty Makary resigns, ending turbulent tenure
    FDA chief Marty Makary has resigned, ending a tenure described as turbulent with leadership upheaval, mass layoffs, political pressure and public disputes with drugmakers. President Trump announce…
    BioPharma Dive · 3mo agoRegulatoryNegative↗ source
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  • Bristol Myers Squibb and China's Hengrui Pharma launch $15.2 billion alliance covering up to 13 early-stage drugs
    Bristol Myers Squibb announced a new partnership with Chinese drugmaker Hengrui Pharma that could be worth more than $15.2 billion and includes up to 13 early-stage drug candidates. The deal refle…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Serif Biomedicines claims breakthrough in non-viral gene therapy demonstrated in monkeys
    Serif Biomedicines, a startup launched by Flagship Pioneering last month, announced it believes it has overcome two key technical hurdles that have limited non-viral gene therapy. The company says…
    Endpoints · 4mo agoPositive↗ source
  • Alcohol epidemic claims nearly 500 U.S. lives daily, exposing systemic public-health failures
    The investigative series "The Deadliest Drug" surveyed more than 100 health researchers, clinicians, patients, industry insiders and lawmakers, and examined scientific literature, treatment protoco…
    STAT · 4mo agoNegative↗ source
  • Supreme Court grants three-day extension on ruling over abortion drug mifepristone
    The U.S. Supreme Court announced it will take an additional three days before issuing a decision in the case concerning the abortion medication mifepristone. The case, Louisiana v. FDA, reached th…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Alkermes reports Phase 3 success for Lumryz; Boehringer announces antibody partnership
    Alkermes announced that its narcolepsy medication Lumryz, which received regulatory approval in 2023, achieved its primary efficacy endpoint in a Phase 3 trial. The study met the predefined criter…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • Pain drug research gains momentum a year after Vertex launch as new startups revive sodium channel targets
    A year after Vertex introduced its breakthrough pain medication, the field of pain drug development is at a pivotal crossroads. Analysts note that renewed scientific focus and investor interest are…
    BioPharma Dive · 4mo agoPositive↗ source
  • Pharma leaders risk industry collapse by over-relying on Chinese drug sourcing, says analyst
    Olivia Kosloff, a senior fellow at the American Economic Liberties Project and co-chair of a Council on Foreign Relations working group, argues that U.S. pharma and biotech executives are jeopardiz…
    STAT · 4mo agoNegative↗ source
  • Eli Lilly suggests low-dose Zepbound and Foundayo could safely maintain weight loss at lower cost
    New trial data indicate that lowering the dose of Eli Lilly's obesity injection Zepbound may still provide effective weight‑loss maintenance while improving safety. The study also highlights Found…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Former FDA Commissioner Marty Makary resigns under pressure, critics call his tenure the weakest in 25 years
    Marty Makary stepped down as FDA commissioner on Tuesday after mounting pressure, ending a tenure that many observers described as the weakest in the agency’s recent history. Critics said he lacke…
    STAT · 3mo agoRegulatoryNegative↗ source
  • EU drafts Critical Medicines Act to increase local production and curb drug shortages
    The European Union has reached a provisional agreement known as the Critical Medicines Act, aimed at strengthening the supply of essential medicines across member states. The plan focuses on incre…
    STAT · 3mo agoRegulatoryPositive↗ source
  • EU Parliament and Council provisionally approve Critical Medicines Act to strengthen drug supply chains
    The European Parliament and the Council have provisionally voted to adopt the Critical Medicines Act, marking a key step toward its implementation. The legislation is designed to reinforce the EU’…
    Endpoints · 3mo agoRegulatoryPositive↗ source
  • FDA Commissioner Marty Makary resigns amid internal turmoil, top food regulator Kyle Diamantas to serve as acting chief
    Food and Drug Administration Commissioner Marty Makary is leaving his post after serving a little over a year, according to an administration source. His tenure was marked by staff departures and i…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Iran war disruptions ripple through pharma supply chain, raising raw material and shipping costs
    The ongoing conflict between Iran and its adversaries has entered its third month, and analysts are now seeing early signs that the fighting is affecting the pharmaceutical supply chain. Disruptio…
    Endpoints · 4mo agoNegative↗ source
  • Hims sales dip as telehealth rivals intensify; Bristol partners with Chinese firm, other biotech updates
    Hims reported lower sales this quarter, attributing the shortfall to growing competition from other telehealth providers. Bristol announced a new partnership with Chinese drugmaker Hengrui Pharma…
    STAT · 4mo agoNeutral↗ source
  • Arvinas and Pfizer license newly approved PROTAC breast cancer drug Veppanu to Rigel Pharmaceuticals
    Arvinas and Pfizer have signed a licensing agreement that transfers ownership of their newly approved breast cancer drug, Veppanu, to San Francisco‑based Rigel Pharmaceuticals. The deal gives Arvi…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • FDA grants breakthrough therapy designation to Emi-Le for advanced adenoid cystic carcinoma
    The U.S. Food and Drug Administration has granted breakthrough therapy designation to Emi-Le for patients with locally advanced, recurrent or metastatic adenoid cystic carcinoma (ACC). Phase 1 tri…
    onclive · 4mo agoCRLPositive↗ source
  • Phase 1 trial shows safety and early PSA responses for novel PSMA radioligand in mCRPC
    A Phase 1 study evaluated the long‑circulating PSMA therapeutic radioligand [177Lu]Lu‑D‑Dan‑Phe‑PSMA in patients with metastatic castration‑resistant prostate cancer. The trial enrolled several dos…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Pfizer, Arvinas sell recently approved breast cancer drug to Rigel for $35 million
    Pfizer and its partner Arvinas have agreed to transfer the commercial rights of a breast cancer therapy to Rigel Pharmaceuticals. The drug had just received regulatory approval, marking a mileston…
    Endpoints · 4mo agoDealNegative↗ source
  • FDA warns of secondary cancers linked to tazemetostat in follicular lymphoma and epithelioid sarcoma
    The FDA issued an alert after the voluntary withdrawal of tazemetostat indications for follicular lymphoma and epithelioid sarcoma, emphasizing the drug's association with secondary primary maligna…
    onclive · 4mo agoRegulatoryNegative↗ source
  • Bayer signals cautious yet aggressive push into pharma acquisitions after five-year pause
    Bayer's CEO Bill Anderson told investors on the first-quarter earnings call that the company is ready to re-enter the pharmaceutical merger-and-acquisition market after a five-year hiatus. He emph…
    Endpoints · 4mo agoDealPositive↗ source
  • Knit Health secures $11.6M seed round to develop doctor-like AI for healthcare operations
    Knit Health, a startup spun out of UC Berkeley, announced it has closed a seed financing round of $11.6 million. The round was co‑led by Uncork Capital, providing the capital the company plans to…
    Endpoints · 4mo agoDealPositive↗ source
  • Immunotherapy trials like PODIUM-303 are reshaping treatment for squamous cell anal cancer, says Dr Parikh
    Dr Aparna R. Parikh, an oncologist at Massachusetts General Hospital and Harvard professor, highlighted the growing feasibility of immunotherapy studies in squamous cell anal carcinoma (SCAC). She…
    onclive · 4mo agoPositive↗ source
  • Capsida Biotherapeutics still unable to determine cause of child death in brain-targeted gene therapy trial
    Capsida Biotherapeutics reported that it still has no explanation for the death of a child who participated in its CAP-002 gene therapy trial last September. The trial was intended to test a new c…
    STAT · 4mo agoNegative readoutNegative↗ source