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  • Former FDA officials and pharma groups weigh in as Supreme Court considers mifepristone regulation
    The Supreme Court is expected to act on a case involving the abortion pill mifepristone after a pause on a federal appeals court order that halted mail‑order distribution. The decision could resha…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Pimicotinib shows 76% response rate and functional benefits in TGCT phase 3 trial
    Dr. Randall discussed results from the phase 3 MANEUVER trial of the CSF-1 receptor inhibitor pimicotinib in patients with tenosynovial giant cell tumor (TGCT). The data were presented at the 2025…
    onclive · 4mo agoPositive readoutPositive↗ source
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  • Biomarker-directed therapies reshape GI cancer treatment, says expert
    In a recent OncLive On Air podcast, host Courtney Flaherty spoke with Dr. Michael J. Pishvaian about the growing role of biomarker-directed strategies in gastrointestinal oncology. Dr. Pishvaian n…
    onclive · 4mo agoNeutral↗ source
  • FDA approves Zenocutuzumab for NRG1 fusion-positive advanced cholangiocarcinoma
    The U.S. Food and Drug Administration has granted approval for zenocutuzumab-zbco, marketed as Bizengri, to treat adult patients with NRG1 fusion‑positive advanced, unresectable or metastatic chola…
    onclive · 4mo agoApprovalPositive↗ source
  • Giants of Cancer Care Unveils 14th Annual Class of Oncology Innovators
    OncLive announced the 14th Annual Giants of Cancer Care inductees, a program that honors oncology leaders whose research, education, mentorship and patient‑focused work have reshaped cancer treatme…
    onclive · 4mo agoPositive↗ source
  • Pierre Fabre aligns with FDA on resubmission of Ebvallo cell therapy
    Pierre Fabre Laboratories announced that it has reached an agreement with the U.S. Food and Drug Administration on a new path for its cell therapy Ebvallo, which had been rejected twice. The FDA w…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
  • Capricor sues Japanese partner over botched Duchenne therapy launch and pricing concerns
    Capricor Therapeutics has filed a lawsuit against its Japanese collaborator Nippon Shinyaku and its subsidiary NS Pharma. The biotech alleges the partners mishandled preparations for the launch of…
    STAT · 4mo agoNegative↗ source
  • Neoadjuvant immunotherapy gaining favor for metastatic melanoma, says Dr. Sznol
    Dr. Mario Sznol discussed current guidance on using neoadjuvant therapy for patients with advanced melanoma. Patients who have active nodal disease detected by imaging or physical exam are now vie…
    onclive · 4mo agoNeutral↗ source
  • Trump reportedly moves to dismiss FDA Commissioner Marty Makary
    President Trump is said to have approved a plan to remove FDA Commissioner Marty Makany, according to several news outlets. The proposed ouster would add to recent turnover in the agency’s senior l…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Capricor sues Nippon Shinyaku over delayed Duchenne drug rollout and pricing formula flaw
    Capricor Therapeutics has filed a lawsuit in New Jersey alleging that Nippon Shinyaku and its US subsidiary NS Pharma have failed to execute agreed upon marketing plans for the company's Duchenne m…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Sacituzumab Govitecan-Trastuzumab Combo Shows Low Response in HER2-Positive Metastatic Breast Cancer After T-DXD
    The phase 2 SATEEN trial evaluated sacituzumab govitecan combined with trastuzumab in patients with HER2-positive metastatic breast cancer who had progressed on T-DXD. The study enrolled 27 evalua…
    onclive · 4mo agoNegative readoutNegative↗ source
  • Spain prepares to isolate over 140 cruise passengers amid hantavirus outbreak
    Spanish authorities are ready to receive more than 140 passengers and crew from a cruise ship flagged with a hantavirus outbreak as it approaches Tenerife. The vessel is expected to dock on Sunday…
    STAT · 4mo agoNegative↗ source
  • OncLive launches weekly quiz covering recent breast, lung and pancreatic cancer updates
    OncLive released its May 8, 2026 weekly news quiz, inviting readers to test their knowledge of recent developments in breast, lung and pancreatic cancers. The quiz highlights several recent oncolo…
    onclive · 4mo agoNeutral↗ source
  • OncLive poll shows oncogene-driven NSCLC as top focus for lung cancer abstracts at ASCO 2026
    OncLive surveyed its LinkedIn and X followers to learn which lung cancer topics will draw the most attention at the 2026 ASCO Annual Meeting in Chicago. The poll asked participants to select the ar…
    onclive · 4mo agoNeutral↗ source
  • Poll Shows Readers Most Excited for PersevERA BC Trial Data at ASCO 2026
    As the 2026 ASCO Annual Meeting draws near, a recent poll asked oncology readers which breast-cancer abstract they are most looking forward to. Respondents could choose among several late-breaking…
    onclive · 4mo agoNeutral↗ source
  • Epidemiologist highlights surge of hantavirus misinformation after cruise ship outbreak
    An outbreak of hantavirus tied to the cruise ship MV Hondius has generated serious health concerns, but online discussion has taken a different turn. Social media users quickly began sharing false…
    STAT · 4mo agoPositive↗ source
  • Immunic appoints Michael Panzara as chief medical officer, coming from Neurvati Neurosciences
    STAT+ columnist Ed Silverman's weekly feature highlights recent personnel changes in pharma. This edition notes a new appointment at Immunic. Immunic has named Michael Panzara its new chief medica…
    STAT · 4mo agoNeutral↗ source
  • Met Gala outfits whimsically matched to biotech logos in annual tradition
    The piece highlights an annual tradition of pairing Met Gala attire with the logos of biotech companies, a playful feature in the STAT newsletter The Readout. For this year’s event, whose theme wa…
    STAT · 4mo agoNeutral↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 4mo ago↗ source
  • STAT+: Pharmalittle: We’re reading about an FDA gender rule change, its program for one-day inspections, and more
    An FDA proposal to remove references to “gender” from its regulations sparked concerns about unintended consequences on research
    STAT · 4mo ago↗ source
  • Dr Gruenbaum on Where Alternative Options to BTK Inhibitors Stand in MCL
    Lore Gruenbaum, PhD, discusses alternative treatments to BTK inhibitors like bispecific antibodies and CAR T-cell therapy in mantle cell lymphoma.
    onclive · 4mo ago↗ source
  • The PYNNACLE Phase 2 trial assessing rezatapopt, a selective p53 reactivator, in patients with advanced or metastatic solid tumors harboring a TP53 Y220C mutation: Interim analysis of patients with ovarian cancer
    Alison Schram, MD, discusses interim PYNNACLE phase 2 data showing that single-agent rezatapopt produced clinically meaningful responses and a manageable safety profile in heavily pretreated patien…
    onclive · 4mo ago↗ source
  • Characterization and Management of Sevabertinib induced Diarrhea in the SOHO 1 study
    This analysis from the SOHO-01 study evaluated the safety profile of sevabertinib in HER2-mutated non–small cell lung cancer, with a specific focus on treatment-related diarrhea. Diarrhea was frequ…
    onclive · 4mo ago↗ source
  • First-Line Danvatirsen Plus Pembrolizumab Fails to Improve Response Rates in Metastatic HNSCC
    Danvatirsen in combination with pembrolizumab did not result in an ORR improvement vs pembrolizumab alone in first-line recurrent/metastatic HNSCC.
    onclive · 4mo ago↗ source
  • Cumulative ADC Toxicities and Closing Reflections: Managing Edema, Fatigue, and Optimizing Long-Term Tolerability
    This concluding segment addresses cumulative toxicities affecting long-term antibody-drug conjugate tolerability, with Hope Rugo, MD and Aaron Lisberg, MD discussing edema, fatigue, and strategies…
    onclive · 4mo ago↗ source