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  • FDA pushes Leqembi subcutaneous decision to Aug. 24; Artiva secures $300M and Pharvaris sets pricing
    The U.S. Food and Drug Administration has postponed its review of the subcutaneous formulation of Leqembi. The original target date earlier this month has been moved to August 24, as Biogen and Eis…
    Endpoints · 6mo agoRegulatoryNeutral↗ 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 · 6mo agoRegulatoryNeutral↗ source
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  • 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 · 6mo agoNegative↗ source
  • Odyssey Therapeutics raises $279 million in IPO, begins Nasdaq trading
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, announced that its initial public offering generated $279 million. The company sold about 15.5 million shares and priced the IPO at…
    Endpoints · 6mo agoDealPositive↗ 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoNegative readoutNegative↗ source
  • Top young AI researchers avoid careers at large pharmaceutical companies
    Mazdak Abulnaga, a 33‑year‑old postdoctoral fellow at MIT and Harvard Medical School, is highlighted as the type of employee pharmaceutical companies hope to attract this year. Despite the demand,…
    Endpoints · 6mo agoNegative↗ 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 · 6mo 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 · 6mo agoNeutral↗ source
  • Natalie Holles appointed CEO after Third Harmonic shutdown; Mark Alles steps down at ADC Biotech
    Natalie Holles quickly found a new role after the decision to wind down operations at Third Harmonic. She has taken over as chief executive, succeeding Elisabet de los Pinos. At the same time, Mar…
    Endpoints · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo 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 · 6mo agoNeutral↗ source
  • Capricor sues Nippon Shinyaku over pricing dispute for Duchenne cell therapy candidate
    Capricor Therapeutics announced it has filed a lawsuit against its Japanese partner Nippon Shinyaku. The suit alleges a flaw in the pricing terms of the distribution and commercialization agreemen…
    Endpoints · 6mo agoNegative↗ source
  • Calls grow for increased recruitment of men into nursing to address workforce shortages
    Men make up only about 12% of the nursing workforce in the United States. The demand for nurses is rising, with roughly 200,000 job openings expected each year as many current nurses retire. The…
    STAT · 6mo agoPositive↗ source