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  • Trump executive order accelerates psychedelic drug development with priority review vouchers, funding and expanded right-to-try
    President Trump signed an executive order that aims to speed the development and approval of psychedelic medicines. The order directs the FDA to issue priority review vouchers, expands right-to-tr…
    STAT · 4mo agoRegulatoryPositive↗ source
  • Avalo's Phase 2 data lifts shares 45% as skin drug shows 42% response in hidradenitis suppurativa
    Avalo Therapeutics reported that its experimental therapy abdakibart met the primary goal of a Phase 2 trial in patients with hidradenitis suppurativa. Both low and high dose groups achieved respon…
    BioPharma Dive · 4mo agoPositive readoutPositive
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  • Gene therapy leaders in Rome flag FDA regulatory shifts as key challenge
    Gene therapy manufacturers gathered in Rome to discuss the sector’s outlook in Europe, with the U.S. Food and Drug Administration’s recent actions dominating conversation. Speakers highlighted rec…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • White House drug strategy endorses treatment but tightens funding for fentanyl test strips
    The White House released a new drug‑policy document on May 4 that lists public‑health measures such as wider access to the overdose‑reversal drug naloxone, medication‑assisted treatment, and the di…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Administration releases detailed report on most-favored-nation drug pricing, projects $529 billion savings
    The White House Council of Economic Advisers released its most detailed analysis yet of the administration's most-favored-nation drug pricing policy. The report defines the MFN pricing approach, w…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • CellCentric secures $220 million Series D to advance oral multiple myeloma drug inobrodib
    CellCentric, a biotech focused on multiple myeloma, announced a $220 million Series D financing led by Venrock. The capital will fund ongoing Phase 2 trials and a planned Phase 3 study of its oral…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sanofi requests removal of teplizumab from FDA fast-track voucher program after director dispute
    Sanofi has formally asked the Food and Drug Administration to withdraw its type 1 diabetes therapy, teplizumab, from the new speedy review voucher program overseen by Commissioner Marty Makary. Th…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Bayer to buy Perfuse for up to $2.45B, bolstering eye drug pipeline
    Centered around a glaucoma therapy in mid-stage testing, the deal is Bayer’s first drug company acquisition in several years and potentially its largest since it purchased AskBio in 2020.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • Color Health expands into cancer treatment coordination with virtual tumor boards
    Color Health, a telehealth firm that currently coordinates cancer screening, is moving into providing and coordinating actual cancer care services. CEO Othman Laraki says the growing complexity of…
    STAT · 4mo agoPositive↗ source
  • FDA authorizes fruit-flavored vapes amid political pressure, sparking debate over youth risk and quitting aid
    The U.S. Food and Drug Administration granted its first authorization for fruit-flavored e-cigarettes on Tuesday, adding mango- and blueberry-tasting products from Los Angeles-based Glas to its app…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • PhRMA launches seven-figure ad campaign against 340B drug discount program
    PhRMA, the leading pharmaceutical lobbying group, announced a new advertising push aimed at the federal 340B drug discount program. The campaign, described as a seven-figure effort, is set to begi…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • STAT+: How a global effort to explore the ‘dark proteome’ is upending our understanding of human disease
    An international team has found thousands of mini-proteins, including some involved in cell division and DNA repair, as well as several unique to cancer cells.
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Health AI progress limited by bad data, newsletter notes
    The latest AI Prognosis newsletter highlights that the quality of health data is a major obstacle for building useful AI tools in medicine. The author explains that many existing datasets contain…
    STAT · 4mo agoNeutral↗ source
  • HHS focuses on overmedication as cruise ship hantavirus outbreak prompts port change
    The Health and Human Services department announced new efforts to curb excessive prescribing, highlighting concerns about overmedication in the United States. At the same time, a cruise ship ancho…
    STAT · 4mo agoNeutral↗ source
  • OpenAI’s health AI policy blueprint seen as reasonable yet self‑serving, experts say
    OpenAI has expanded its health‑focused AI tools, rolling out ChatGPT Health for consumers, a hospital‑oriented ChatGPT for Healthcare, and a version for clinicians. Alongside the clinician chatbot,…
    STAT · 4mo agoRegulatoryNegative↗ source
  • PeaceHealth abandons plan to outsource Oregon emergency doctors to ApolloMD after lawsuit and local opposition
    PeaceHealth, a nonprofit health system in Oregon, announced Wednesday that it will not move its emergency department staffing to the national physician staffing firm ApolloMD. The decision reverse…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Dementia care faces ambiguous loss, a unique grief that strains relationships
    Jason Karlawish, a professor of medicine and neurology at the University of Pennsylvania, wrote an opinion piece on the concept of ambiguous loss in dementia care. He reflects on a recent interview…
    STAT · 4mo agoNeutral↗ source
  • Dr. Glaucomflecken protests corporate staffing of PeaceHealth emergency department in Oregon
    Dr. Glaucomflecken, the online persona of physician Will Flanary, hosts the First Opinion Podcast where he blends humor with health‑care commentary. He has become a vocal critic of PeaceHealth’s p…
    STAT · 4mo agoNegative↗ source
  • Cytokinetics' Myqorzo meets primary goals in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its experimental therapy Myqorzo achieved its primary endpoints in a Phase 3 study of patients with non-obstructive hypertrophic cardiomyopathy (HCM). The trial showed…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source
  • Cytokinetics’ Myqorzo hits twin efficacy targets in genetic heart disease trial, while Viridian reports positive Phase 3 data for elegrobart
    Cytokinetics announced that its experimental heart‑failure drug Myqorzo achieved both primary efficacy endpoints in a study of patients with genetic cardiomyopathy, showing significant symptom impr…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Vertex Q1 revenue slightly below forecasts as key drug sales miss estimates, but Alyftrek revenue surges
    Vertex Pharmaceuticals reported first‑quarter revenue of about $3 billion, falling just short of Wall Street expectations. The modest miss left the stock largely unchanged on the day of the release…
    BioPharma Dive · 4mo agoEarningsNeutral↗ source
  • Cytokinetics' Myqorzo hits both primary endpoints in Phase 3 trial for non-obstructive hypertrophic cardiomyopathy
    Cytokinetics announced that its drug Myqorzo achieved the dual efficacy targets in the Phase 3 ACACIA trial, which evaluated patients with non-obstructive hypertrophic cardiomyopathy (HCM), an inhe…
    STAT · 4mo agoPositive readoutPositive↗ source
  • Hantavirus outbreak on cruise ship highlights risks of U.S. exclusion from WHO
    Three passengers have died and seven others are ill after a suspected hantavirus infection was identified on a cruise vessel anchored off Cape Verde. The World Health Organization has taken the lea…
    STAT · 4mo agoRegulatoryNegative↗ source
  • J&J's IBD combo therapy misses statistical goal but will be tested in a focused patient subgroup
    Johnson & Johnson reported that its experimental combination of Tremfya and Simponi, called JNJ-4804, did not achieve a statistically significant improvement in a Phase 2b study of inflammatory bow…
    STAT · 4mo agoNegative readoutNegative↗ source
  • Viridian's elegrobart shows strong results in chronic thyroid eye disease trial, challenging Amgen's Tepezza
    Viridian Therapeutics announced that its injectable drug elegrobart met its primary goals in a late-stage study of patients with chronic thyroid eye disease. The trial reported response rates of 50…
    BioPharma Dive · 4mo agoPositive readoutPositive↗ source