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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
  • Medicare’s new RAPID coverage pathway speeds adult device access, but pediatric devices still lag
    The Centers for Medicare and Medicaid Services and the FDA introduced the Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway. The new process promises Medicare natio…
    STAT · 4mo agoRegulatoryPositive↗ source
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  • Odyssey Therapeutics raises $279 million in IPO, adds $25 million private sale
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, completed an initial public offering that generated $279 million by selling 15.5 million shares at $18 each. The company also secured…
    BioPharma Dive · 4mo agoDealPositive↗ 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
  • 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
  • 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 agoDealNeutral↗ source
  • FDA proposes stripping gender references from regulations, prompting research concerns
    The U.S. Food and Drug Administration has issued a proposal to eliminate references to gender in its regulatory language. The change is intended to modernize the rules but has drawn attention from…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Experts see bispecific antibodies and CAR-T therapies emerging as future options beyond BTK inhibitors for mantle cell lymphoma
    Lore Gruenbaum, PhD, chief scientific officer and senior vice president of research at Blood Cancer United, discussed alternative treatment strategies for mantle cell lymphoma (MCL) that go beyond…
    onclive · 4mo agoPositive↗ source
  • Phase 2 interim data show rezatapopt yields meaningful responses in heavily pretreated ovarian cancer patients with TP53 Y220C mutation
    Alison Schram, MD presented interim results from the PYNNACLE Phase 2 trial of rezatapopt, a selective p53 reactivator, in patients whose tumors carry the TP53 Y220C mutation. The analysis focused…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Combination of danvatirsen and pembrolizumab fails to boost response in first-line metastatic head-and-neck cancer
    The phase II PEMDA-HN trial evaluated adding the STAT3 antisense oligonucleotide danvatirsen to pembrolizumab in patients with untreated recurrent or metastatic head and neck squamous cell carcinom…
    onclive · 4mo agoNegative readoutNegative↗ source
  • Aging scientific workforce grapples with rising fabricated citations as hantavirus cruise ship outbreak drags on
    A new analysis highlights that an increasingly senior scientific workforce is coinciding with a surge in fabricated citations across medical journals, raising concerns about research integrity. Th…
    STAT · 4mo agoNeutral↗ 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
  • Sevabertinib-related diarrhea in HER2-mutated NSCLC is generally low-grade and manageable, study shows
    The SOHO-01 trial examined the safety of sevabertinib in patients with HER2-mutated non-small cell lung cancer, focusing on treatment-related diarrhea. Diarrhea occurred frequently but was mostly…
    onclive · 4mo agoPositive readoutPositive↗ source
  • Experts discuss managing edema, fatigue and long-term tolerability of antibody-drug conjugates in breast and lung cancer
    The piece concludes a series on antibody-drug conjugates, noting that cumulative toxicities can restrict long-term treatment. Dr. Hope Rugo and Dr. Aaron Lisberg point out that edema and fatigue a…
    onclive · 4mo agoNeutral↗ source
  • Six former FDA officials explain why they left the agency during the Trump era
    STAT's weekly video series STATus Report recently featured a road-trip edition in which reporter Lizzy Lawrence traveled to the Washington suburbs to talk with former FDA staff. The interviews inc…
    STAT · 4mo agoNeutral↗ 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