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  • Lakefront Biotherapeutics rebrands from Galapagos as it seeks turnaround from Chicago office
    Lakefront Biotherapeutics, formerly known as Galapagos, announced a rebranding effort aimed at reviving the company’s fortunes. The change reflects a strategic shift as the firm looks to reposition…
    Endpoints · 6mo agoNeutral↗ source
  • Oncologist Charles Blanke reflects on cancer research journey and push for medical aid in dying
    The latest episode of the "How This Is Building Me" podcast features D. Ross Camidge, MD, PhD, speaking with Charles D. Blanke, MD, a professor at Oregon Health & Science University. The conversati…
    onclive · 6mo agoPositive↗ source
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FDA approves vepdegestrant for ESR1-mutated ER-positive advanced breast cancer
On May 1, 2026 the FDA gave its first approval to vepdegestrant, an oral selective estrogen receptor degrader, for adult patients with estrogen receptor-positive, HER2-negative breast cancer that c…
onclive · 6mo agoApprovalPositive↗ source
  • Isomorphic Labs secures $2.1 billion Series B, cementing AI drug-discovery leadership
    Isomorphic Labs announced on Tuesday that it has closed a $2.1 billion Series B financing round. The sizable round underscores the company’s position as a bellwether for using artificial intellige…
    Endpoints · 6mo agoDealPositive↗ source
  • Bristol Myers Squibb partners with Hengrui Pharma in $15.2 billion, 13-asset deal
    Bristol Myers Squibb announced a partnership with China’s Hengrui Pharma that includes 13 assets. The transaction is reported to be valued at up to $15.2 billion, highlighting the scale of collabo…
    Endpoints · 6mo agoDealNeutral↗ 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 · 6mo agoRegulatoryNegative↗ source
  • 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 · 6mo 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 · 6mo agoPositive↗ 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 · 6mo 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 · 6mo agoPositive↗ 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 · 6mo agoPositive readoutPositive↗ 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 · 6mo agoRegulatoryPositive↗ 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 · 6mo agoNegative↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoPositive↗ source
  • Honesty and Humor Offer Hope in Breast Cancer Survivorship, Says Dr Nunnery and Survivor Annie Bond
    The Breast Cancer Briefing podcast, hosted by Dr Sara Nunnery of Tennessee Oncology, featured a conversation with Annie Bond, a breast cancer survivor and patient advocate. Bond, who was first dia…
    onclive · 6mo agoPositive↗ source
  • FDA Commissioner Marty Makary steps down after weeks of uncertainty
    Marty Makary, the commissioner of the U.S. Food and Drug Administration, announced his resignation on Tuesday. The decision came after his employment status was uncertain for several days, accordi…
    Endpoints · 6mo agoRegulatoryNeutral↗ source
  • Fox Chase Cancer Center and Labcorp launch study of ultra-sensitive blood test for early-stage lung cancer recurrence
    Fox Chase Cancer Center and Labcorp announced a new clinical trial to evaluate a tumor-informed, whole-genome sequencing ctDNA minimal residual disease (MRD) assay for early-stage non-small cell lu…
    onclive · 6mo agoPositive↗ source
  • FDA reopens comment period for BHT and launches post-market chemical safety program
    The U.S. Food and Drug Administration announced two actions as part of its ongoing food chemical safety agenda. The agency will reopen the comment period for the Request for Information on butylat…
    fda press · 6mo agoRegulatoryNeutral↗ source