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  • Ebola surge in DRC and hantavirus cases on cruise ship highlight gaps in global outbreak preparedness
    Recent reports from the Democratic Republic of Congo describe an Ebola outbreak in Ituri province with 246 suspected cases and 65 deaths, and early testing points to a non‑Zaire ebolavirus strain.…
    STAT · 3mo agoNegative↗ source
  • FDA drug center acting director Tracy Beth Høeg resigns amid leadership vacuum
    Tracy Beth Høeg, the acting director of the FDA’s Center for Drug Evaluation and Research, is leaving the agency, according to three sources familiar with the matter. Her departure follows the res…
    STAT · 3mo agoRegulatoryNegative↗ source
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  • Expert outlines sequencing strategies for relapsed/refractory multiple myeloma amid rise of T-cell redirecting therapies
    Dr. Diana Cirstea, a specialist in multiple myeloma, explained how treatment sequencing is evolving for patients with relapsed or refractory disease. She highlighted that the growing availability o…
    onclive · 3mo agoNeutral↗ source
  • FDA drug division chief Tracy Beth Høeg expected to depart amid leadership shakeup
    Tracy Beth Høeg, who leads the FDA’s Center for Drug Evaluation and Research, is reported to be leaving the agency. Her exit comes shortly after former Commissioner Marty Makary stepped down, sugg…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Pembrolizumab with BCG shows 92% 6-month complete response in very high-risk T1 bladder cancer
    A clinical study evaluated the combination of pembrolizumab and bacillus Calmette-Guérin (BCG) in patients with very high-risk T1 non-muscle invasive bladder cancer who had not previously received…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Detalimogene Voraplasmid Achieves 54% Complete Response in BCG-Unresponsive Bladder Cancer
    A clinical study of detalimogene voraplasmid reported a 54% complete response rate in patients with heavily pretreated, BCG‑unresponsive non‑muscle‑invasive bladder cancer that also had carcinoma i…
    onclive · 3mo agoPositive readoutPositive↗ source
  • Supreme Court blocks lower court ruling, keeps mail-order access to abortion pill mifepristone
    The Supreme Court issued an indefinite stay that preserves mail-order access to the abortion medication mifepristone. The order maintains the ability for providers to prescribe the drug through pha…
    BioPharma Dive · 3mo agoRegulatoryPositive↗ source
  • Candel Therapeutics shares 20-month follow-up data for its prostate cancer candidate ahead of FDA filing
    Candel Therapeutics announced that it has completed a long-term follow‑up study of patients treated with its prostate cancer drug. The data extend to about 20 months after treatment and are intende…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • FDA Commissioner Marty Makary Resigns After Turbulent Tenure
    Marty Makary stepped down as commissioner of the U.S. Food and Drug Administration on Tuesday, ending a period marked by controversy and intense scrutiny. His resignation follows a series of publi…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Ebola outbreak confirmed in Congo's Ituri province, 65 deaths among 246 suspected cases
    Africa CDC announced a new Ebola outbreak in the remote Ituri province of the Democratic Republic of Congo, noting 246 suspected infections and 65 fatalities. Most of the reported cases and deaths…
    STAT · 3mo agoNegative↗ source
  • UK election may reshape drug pricing while US urges Germany to pay more for medicines
    The upcoming political contest in the United Kingdom is being watched for its possible effects on how medicines are priced domestically. Analysts suggest that a change in government could lead to n…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Supreme Court temporarily restores telehealth access to mifepristone amid ongoing legal fight
    The Supreme Court on Thursday reversed a 5th Circuit order and allowed mifepristone to be prescribed and mailed through telehealth for the time being. The reversal follows a lawsuit brought by Lou…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • Supreme Court temporarily blocks ruling, keeping mail-order mifepristone legal
    The U.S. Supreme Court issued an order that temporarily blocks a federal appeals court decision that would have required women to obtain abortion pills in person. The temporary stay preserves the a…
    STAT · 3mo agoRegulatoryPositive↗ source
  • Mid-size pharma firms drive surge in biopharma M&A activity
    The article notes that 2026 is shaping up as one of the busiest years for biopharma mergers and acquisitions on record. Unlike previous years dominated by large multinational companies, a broader…
    Endpoints · 3mo agoDealNeutral↗ source
  • Prevention and personalized skin care highlighted as future direction for melanoma oncodermatology
    Dr. Beth McLellan, a dermatologist, emphasizes that preventing radiation-induced skin damage is becoming a central focus in melanoma care. She also points out the need for equitable access to scal…
    onclive · 3mo agoPositive↗ source
  • U.S. officials urge Germany to raise drug prices in trade talks
    U.S. Trade Representative Jamieson Greer and senior health adviser Chris Klomp met with German Ambassador Jens Hanefeld at a breakfast briefing to press Germany to increase the price it pays for pr…
    STAT · 3mo agoRegulatoryNeutral↗ source
  • DOJ alleges Yale and UCLA med schools discriminate against white and Asian applicants
    The U.S. Justice Department sent a letter to Yale School of Medicine on Thursday accusing it of illegal discrimination against applicants who are not Black or Hispanic. The allegation follows a si…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Biopharma M&A stays robust as companies shift focus from megadeals to smaller targets
    The article notes that despite a slowdown in large megadeals, overall merger and acquisition activity in the biopharma sector remains strong. Companies are adopting multi‑pronged strategies to add…
    Endpoints · 3mo agoDealNeutral↗ source
  • PSA Blood Test Found to Lower Prostate Cancer Deaths, Review Shows
    A new Cochrane review concludes that prostate-specific antigen (PSA) screening is likely to reduce deaths caused by prostate cancer. The analysis combined data from six trials involving roughly 80…
    STAT · 3mo agoPositive↗ source
  • Takeda to Pay $13.6 Million to Resolve DOJ Claims of Doctor Kickbacks for Antidepressant Trintellix
    Takeda Pharmaceuticals has agreed to pay $13.6 million to settle federal allegations that it provided illegal kickbacks to physicians to encourage prescriptions of its antidepressant, Trintellix. T…
    STAT · 3mo agoRegulatoryNegative↗ source
  • Amgen tightens 340B program rules, expanding pharmacy claims data requirements
    Amgen announced it is expanding the data it requires from pharmacies that dispense its products under the federal 340B drug discount program. The new policy will obligate participating pharmacies…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Aardvark to unblind rare disease trial after FDA places full clinical hold; Alumis issues verdict on Acelyrin asset
    Aardvark's rare disease candidate is under a full clinical hold by the FDA, which has paused all dosing and data collection. The company says it intends to unblind the trial data despite the hold,…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • OncLive poll highlights top GI cancer abstracts and interest areas for ASCO 2026
    OncLive conducted a poll among its audience to gauge which gastrointestinal cancer abstracts are expected to generate the most interest at the upcoming ASCO Annual Meeting. The poll results identi…
    onclive · 3mo agoNeutral↗ source
  • Older adults warn that changing pill colors and shapes cause dangerous confusion
    Barbara Wolf, a 73‑year‑old from Birmingham, Alabama, takes six medications each day and relies on the color, shape and size of each pill to keep her regimen straight. She recently received a refi…
    STAT · 3mo agoNegative↗ source
  • Supreme Court Keeps Mail Delivery of Abortion Pill Mifepristone in Place
    The Supreme Court issued a ruling on Thursday that preserves the ability to ship the abortion medication mifepristone through the postal service. The decision leaves in place the existing safety r…
    Endpoints · 3mo agoRegulatoryNeutral↗ source