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4,202 stories matching this filter · ← front page

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  • Bristol Myers ends $100M Phase 1 cancer ADC program
    Bristol Myers Squibb announced it has discontinued development of its Phase 1 antibody-drug conjugate candidate BMS-986497/ORM-6151. The decision follows a review of early clinical data, leading t…
    Endpoints · 1mo agoNegative↗ source
  • CMS offers Medicare pricing program exemptions to drugmakers who add Medicaid rebates
    The Centers for Medicare & Medicaid Services (CMS) has announced that drug manufacturers can be exempted from two Medicare pricing demonstration programs. The exemption is conditional on the compan…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
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  • Rare genetic variant linked to much higher lung cancer risk in never-smokers
    Researchers have discovered a very rare genetic variant that dramatically increases the odds of developing lung cancer among people who have never smoked. The study, published in Science, reports a…
    STAT · 1mo agoPositive↗ source
  • Cellares signs first Asian manufacturing deal with Taiwan's GenomeFrontier Therapeutics for CAR-T production
    Cellares announced a new partnership with Taiwanese biotech GenomeFrontier Therapeutics, marking the manufacturer’s first collaboration in Asia. The agreement will see Cellares evaluate and potenti…
    Endpoints · 1mo agoDealNeutral↗ source
  • Goa Therapeutics launches with $15.5M funding to develop fast-acting alcohol sobering drug
    Goa Therapeutics announced its launch, backed by $15.5 million raised mainly from individual industry leaders, and has filed for an initial public offering that could raise up to $75 million. The…
    Fierce Biotech · 1mo agoPositive↗ source
  • Biotech hedge fund launches North Immunology to develop long-acting antibody for atopic dermatitis
    STAT+ hedge fund is creating a new immunology company called North Immunology with the goal of delivering a better, long-acting antibody therapy for atopic dermatitis. The concept originated two y…
    STAT · 1mo agoPositive↗ source
  • FDA hiring drive to add 2,000 staff stalls due to overwhelmed HR center
    The Food and Drug Administration says it plans to bring on more than 2,000 new employees, a move aimed at rebuilding staff after the 2025 cuts that eliminated about 3,500 positions. Agency officia…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • North Immunology to go public via reverse merger, targeting eczema with bispecific antibody
    North Immunology, a private biotech incubated by ADAR1 Capital Management, announced it will become a public company through a reverse merger with Nasdaq‑listed Aethlon Medical. The merged entity…
    Fierce Biotech · 1mo agoDealNeutral↗ source
  • SK Biopharma signs $315 million deal with 1ST Biotherapeutics for preclinical Parkinson’s drug 1ST-104
    SK Biopharmaceuticals has entered a licensing agreement with South Korean biotech 1ST Biotherapeutics that could be worth up to $314.8 million. The deal includes an upfront payment of $1.8 million,…
    Fierce Biotech · 1mo agoDealPositive↗ source
  • Longeveron’s pediatric heart stem-cell trial misses primary endpoint, prompting cost cuts
    Longeveron reported that its phase 2b Elpis II trial of the stem-cell product laromestrocel in infants with hypoplastic left heart syndrome failed to meet its primary efficacy endpoint. The study…
    Fierce Biotech · 1mo agoNegative readoutNegative↗ source
  • CMS launches 10-year ACCESS health-tech pilot for Medicare
    CMS recently held an event to commemorate the summer launch of the ACCESS model, a decade-long pilot aimed at integrating health-technology solutions into Medicare. The program will test new digit…
    Endpoints · 1mo agoRegulatoryNeutral↗ source
  • Kennedy appoints eight specialists to U.S. Preventive Services Task Force, ending year-long vacancy
    Health secretary Robert F. Kennedy Jr. appointed eight new members to the U.S. Preventive Services Task Force, filling vacancies after the panel had not met for more than a year. The appointees in…
    STAT · 1mo agoNeutral↗ source
  • Endpoints 11 reveals 2026’s most promising biotech startups at Boston gala
    The Endpoints editorial team announced the Endpoints 11 list, highlighting the most exciting biotech startups of 2026. The selection process involved months of research, interviews with executives,…
    Endpoints · 1mo agoNeutral↗ source
  • Startup launches trial of psychedelic-style drug for Parkinson’s symptom
    A new biotech startup announced it will begin preclinical testing of a psychedelic-like compound aimed at alleviating a specific symptom of Parkinson’s disease. The company plans to evaluate the d…
    STAT · 1mo agoNeutral↗ source
  • Shift away from oppositional defiant disorder reflects changing views on child noncompliance
    Lawrence Diller, a behavioral pediatrician, writes about a noticeable shift in how clinicians label children who resist authority. He recounts a recent call from a mother who asked whether her son…
    STAT · 1mo agoNeutral↗ source
  • Definium shares new psychedelics data and court reprieve for international researchers discussed on The Readout LOUD
    The latest episode of STAT's "The Readout LOUD" podcast covered two timely topics: Definium's recently released psychedelics data and a court decision that gave international scientists a brief leg…
    STAT · 1mo agoNeutral↗ source
  • FDA hiring delays persist despite expectations, and Bavarian Nordic names new CEO
    The recent discussion about a hiring surge at the U.S. Food and Drug Administration following last year’s DOGE budget cuts has not materialized as expected. Industry observers had anticipated a rap…
    STAT · 1mo agoRegulatoryNeutral↗ source
  • Bavarian Nordic appoints former Sanofi, AstraZeneca and Pfizer executive Tarja Stenvall as CEO
    Bavarian Nordic announced that Tarja Stenvall will become its president and chief executive, succeeding Paul Chaplin. Stenvall brings decades of experience from senior roles at Sanofi, AstraZeneca…
    Endpoints · 1mo agoNeutral↗ source
  • Health Secretary RFK Jr. delivers anti‑vaccine keynote at Children’s Health Defense conference
    Robert F. Kennedy Jr., the U.S. health secretary, opened the Children’s Health Defense conference with a keynote that focused on his criticism of vaccines. The speech revisited his broader health…
    STAT · 1mo agoNegative↗ source
  • General Catalyst outlines tech collaborations with Summa Health after hospital acquisition
    General Catalyst, a venture capital firm, is now describing how it plans to integrate technology with Summa Health following its purchase of the hospital network. The firm says the focus will be o…
    Endpoints · 1mo agoNeutral↗ source
  • Chutes & Ladders—Legend poaches Novartis vet to boost commercial potential
    After former Legend Biotech CEO Ying Huang, Ph.D., left the company suddenly in July, Legend has found its permanent CEO, poaching Novartis veteran Ingrid Zhang as the CAR-T specialist eyes its nex…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Zocdoc adds chatbot scheduling and updates on Medicare ACCESS
    Zocdoc announced that its platform now lets users book medical appointments directly through chatbots and health‑plan websites. The new integration means patients can schedule visits without leavi…
    STAT · 1mo agoNeutral↗ source
  • Health secretary Kennedy launches program to accelerate autism diagnosis
    U.S. health secretary Robert F. Kennedy Jr. announced a new initiative aimed at speeding up autism assessments during a keynote at a Children’s Health Defense conference. He said the existing diag…
    STAT · 1mo agoPositive↗ source
  • STAT+: FDA approves a new gene therapy for Sanfilippo syndrome, an ultra-rare disease
    The FDA approved a new gene therapy for Sanfilippo syndrome type A, an ultra-rare disease sometimes known as childhood Alzheimer’s.
    STAT · 1mo ago↗ source
  • FDA approves Ultragenyx's gene therapy for Sanfilippo syndrome type A
    The FDA granted full approval to a rare disease gene therapy from Ultragenyx on Thursday, giving the company a much-needed boost in an otherwise difficult year. The therapy, called UX111, will be b…
    Endpoints · 1mo ago↗ source