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  • Moderna and Merck report success for personalized mRNA vaccine in late-stage melanoma trial
    Moderna and Merck announced that their personalized mRNA cancer vaccine succeeded in a late-stage melanoma study. The vaccine, called intismeran, was evaluated in a randomized Phase 3 trial, the fi…
    STAT · 19d agoPositive readoutPositive↗ source
  • Heidi Overton nominated as FDA commissioner, seen as boost for psychedelics and non-opioid pain drugs
    President Donald Trump announced that he will nominate Heidi Overton, a current White House policy advisor, to serve as the next FDA commissioner pending Senate confirmation. Analysts say Overton’…
    BioSpace · 19d agoRegulatoryNeutral↗ source
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fda recalls67
fda medwatch60
fda press38
1084
Psychiatry & CNS858
Ophthalmology491
Pain470
Endocrinology & Metabolism466
Infectious Disease437
  • Moderna cancer vaccine data lifts investor confidence, shares jump to multi-year highs
    Moderna has long said it wants to broaden its portfolio beyond infectious-disease vaccines. The company has been working on a cancer vaccine and investors have been waiting for late-stage trial res…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Enveda’s oral obesity pill shows strong GI safety in Phase 1, paving way for trials in patients off GLP-1 drugs
    Enveda reported that its Phase 1 study of the oral obesity candidate ENV-308 demonstrated an exceptional gastrointestinal safety profile in healthy volunteers. The topline data, released on August…
    BioSpace · 19d agoPositive readoutPositive↗ source
  • Takeda’s FDA-approved Orzeyful expands treatment to all narcolepsy symptoms, challenging existing sleep drugs
    The U.S. Food and Drug Administration approved Takeda's drug Orzeyful in August, marking the first therapy that addresses the full spectrum of narcolepsy symptoms, including cataplexy and excessive…
    BioSpace · 19d agoApprovalPositive↗ source
  • Novo Nordisk leads early in oral obesity market, but analysts doubt lasting advantage
    Novo Nordisk's oral formulation of Wegovy generated DKK 3.22 billion (about $496 million) in revenue in the second quarter of 2026, far outpacing Eli Lilly's newly approved oral weight‑loss pill Fo…
    BioSpace · 19d agoNeutral↗ source
  • Trump administration nominates Heidi Overton as FDA commissioner
    President Donald Trump has nominated Heidi Overton, the White House deputy director of domestic policy, to serve as the next commissioner of the Food and Drug Administration. Overton has been desc…
    STAT · 19d agoRegulatoryNeutral↗ source
  • Trump nominates Heidi Overton as FDA commissioner, known for criticism of vaccine mandates and abortion pills
    President Donald Trump announced Heidi Overton as his nominee for FDA commissioner, marking the start of a new chapter for the agency. Overton has previously voiced criticism of vaccine requiremen…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Trump administration eyes Heidi Overton as next FDA commissioner
    President Donald Trump is reported to be preparing a nomination for Heidi Overton to become the next commissioner of the Food and Drug Administration, according to multiple news outlets. Overton i…
    BioPharma Dive · 19d agoRegulatoryNeutral↗ source
  • Trump administration expected to nominate White House policy aide Heidi Overton as FDA commissioner
    President Donald Trump is expected to put forward White House deputy director of domestic policy Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to STAT.…
    STAT · 19d agoRegulatoryNeutral↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump is reported to be selecting Deputy Director of the White House Domestic Policy Council Heidi Overton, a physician, to be the next FDA commissioner, pending Senate confirmatio…
    BioSpace · 19d agoRegulatoryNeutral↗ source
  • Biokin's EGFR-HER3 bispecific ADC succeeds in late-stage Chinese lung cancer trial
    Chinese biotech Biokin announced that its EGFRxHER3 bispecific antibody-drug conjugate met its primary endpoint in a late-stage trial in a genetically defined subset of non-small cell lung cancer (…
    Endpoints · 19d agoPositive readoutPositive↗ source
  • Trump nominates White House aide Heidi Overton as FDA commissioner
    President Donald Trump announced his intent to nominate Heidi Overton, M.D., Ph.D., a current White House aide, to lead the Food and Drug Administration. Overton earned her medical degree from the…
    Fierce Biotech · 19d agoRegulatoryNeutral↗ source
  • Tolerance Bio secures up to $260 M for thymus‑targeting fusion protein, moves into Phase 2 trials
    Tolerance Bio, a Philadelphia biotech founded in October 2024, has signed a licensing agreement to acquire rights to NeoImmuneTech’s long‑acting IL‑7 fusion protein, efineptakin alfa, for up to $26…
    Fierce Biotech · 19d agoDealPositive↗ source
  • AI fuels a parallel, unregulated medical ecosystem outside traditional care
    Arya Rao, a Harvard‑MIT M.D.-Ph.D. candidate, and Marc Succi, a Harvard radiology professor, argue that financial incentives are pulling major AI firms into health care, creating a shadow system se…
    STAT · 19d agoNegative↗ source
  • Accrediting body weighs dropping explicit racism language from public health curriculum standards
    The Council on Education for Public Health is reviewing its core competency language for accredited schools. Currently the standards require students to discuss how structural bias, social inequit…
    STAT · 19d agoRegulatoryNegative↗ source
  • Federal appeals court revives portion of Teva's Medicare price-negotiation lawsuit amid Austedo discount plans
    Federal appeals court in the D.C. Circuit issued a decision Tuesday that partially overturns a lower‑court ruling that had dismissed Teva's challenge to Medicare's drug pricing negotiations. The r…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • Trump expected to nominate Heidi Overton as new FDA commissioner
    President Donald Trump is expected to nominate Heidi Overton as the next commissioner of the U.S. Food and Drug Administration, according to a source familiar with the decision. Overton's selectio…
    Endpoints · 19d agoRegulatoryNeutral↗ source
  • New CDC Director Erica Schwartz vows to speak truth to power and champion transparency
    In an all-hands meeting recorded by STAT, Erica Schwartz, the newly appointed director of the Centers for Disease Control and Prevention, told staff she is very comfortable and very confident in sp…
    STAT · 19d agoRegulatoryPositive↗ source
  • Lilly's mid‑stage weight‑loss trial looms as amylin design becomes a key differentiator
    The pharmaceutical community is watching a growing debate over how best to design amylin‑based medicines. Analysts say that the structural choices made by companies could determine which candidates…
    Endpoints · 19d agoNeutral↗ source
  • Biopharma hiring surges in New Jersey, 11 companies post dozens of new roles
    BioSpace data shows job postings for biopharma positions in New Jersey have risen year over year, with a notable 73% jump in July compared with the same month last year. The upward trend has persi…
    BioSpace · 19d agoPositive↗ source
  • Merck partners with Sarah Cannon to accelerate community oncology trials
    Merck & Co. has entered a collaboration with the Sarah Cannon Research Institute to expand patient access to oncology trials at community sites across the United States. The partnership will use S…
    Fierce Biotech · 19d agoDealPositive↗ source
  • Amylyx reports promising GLP-1 blocker results while Summit faces survival setbacks and Definium shows anxiety therapy benefit
    Amylyx said its investigational GLP-1 blocker avexitide cut the combined rate of level 2 and level 3 hypoglycemic events by about 55% in patients with post‑bariatric hypoglycemia, beating analyst e…
    BioSpace · 19d agoNeutral↗ source
  • Biotech and Academia Explore New Partnership Models to Boost Drug Development
    The article notes that declining alternative funding and a drop in research grants are forcing biotech companies and universities to rethink how they collaborate. At the 2026 Chief Medical Officer…
    Fierce Biotech · 19d agoPositive↗ source
  • Emerging Biotechs Can Speed Development with Tailored Global Trial Strategies, Panel Says
    A panel of biotech chief medical officers and CRO executives discussed how small biotechs can accelerate clinical development by using fit-for-purpose global trial designs. They highlighted both t…
    Fierce Biotech · 19d agoNeutral↗ source