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  • Nourish secures $100M funding, valuation climbs to $1.75B
    Nourish, a New York-based telehealth platform that connects patients with nutritionists, announced a fresh financing round. The round raised $100 million and lifted the company's valuation to abou…
    Endpoints · 3mo agoDealPositive↗ source
  • Paragon Therapeutics moves migraine-focused Mentari Therapeutics public via reverse merger
    Paragon Therapeutics, a hub-and-spoke biotech company, is taking its migraine drug subsidiary Mentari Therapeutics public through a reverse merger. The approach follows Paragon's prior use of reve…
    Endpoints · 3mo agoDealNeutral↗ source
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  • TrumpRx expands catalog with over 600 additional generic drugs
    The White House announced that the TrumpRx direct‑to‑consumer platform has added a large batch of new generic medicines. The expansion brings the total number of generics available on the site to w…
    Endpoints · 3mo agoPositive↗ source
  • Health Tech team hosts consumer health discussions at FT US Pharma and Biotech Summit
    On Thursday, the Health Tech team led a series of conversations at the Financial Times’ US Pharma and Biotech Summit, an event organized in collaboration with Endpoints News. The sessions focused…
    Endpoints · 3mo agoNeutral↗ source
  • FDA approves AstraZeneca’s baxdrostat for select hypertension patients
    AstraZeneca announced that the U.S. Food and Drug Administration has granted approval for its blood‑pressure pill baxdrostat, targeting a specific group of patients with hypertension. The approval…
    Endpoints · 3mo agoApprovalPositive↗ source
  • Amgen defends Tavneos as FDA, European regulators and Japanese doctors raise safety concerns
    Amgen said it continues to support its rare-disease therapy Tavneos despite recent safety alerts. The U.S. FDA has indicated it wants the drug removed from the market after a report of 20 deaths l…
    Endpoints · 3mo agoRegulatoryNegative↗ source
  • Merck and Kelun-Biotech's ADC sac-TMT secures first global Phase 3 win ahead of schedule
    Merck and China-based Kelun-Biotech reported that their experimental antibody-drug conjugate sac-TMT achieved a positive outcome in a global Phase 3 study, marking the first such success for the ca…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Republican lawmaker releases FDA analysis of alleged pediatric Covid vaccine deaths
    A Republican congressman has made public an analysis that the FDA commissioned to examine claims of child deaths linked to Covid-19 vaccines. The study was initiated by former senior FDA officials…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Regeneron signs up to $125 million deal with Parabilis to target difficult drug targets
    Regeneron announced a deal with Parabilis Medicines valued up to $2.2 billion, with an upfront payment of $125 million. The agreement aims to give Regeneron access to Parabilis’s platform that dis…
    Endpoints · 3mo agoDealNeutral↗ source
  • Regeneron's LAG-3 inhibitor fianlimab fails Phase 3 skin cancer trial
    Regeneron announced that its experimental LAG-3 inhibitor fianlimab did not meet its primary endpoint in a late-stage trial for a skin cancer indication. The Phase 3 study was designed to evaluate…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Design Therapeutics reports early Friedreich's ataxia trial shows 6.4-point improvement; Vincentage reports Chinese obesity data
    Design Therapeutics disclosed Phase 1/2 results for its Friedreich's ataxia candidate DT-216P2. The trial administered a 1 mg/kg dose and reported an average 6.4-point improvement on the study endp…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • Supreme Court declines to hear pharma challenges to Medicare drug price negotiations
    The U.S. Supreme Court has refused to review several lawsuits filed by drug makers contesting the Medicare drug price negotiation provisions of the Inflation Reduction Act. The cases, brought by co…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • FDA Commissioner Marty Makary resigns as Biogen unveils new Alzheimer’s data
    Marty Makary announced his resignation from the role of FDA commissioner, ending his tenure amid recent political developments. Biogen disclosed fresh data from its Alzheimer’s disease program, ad…
    Endpoints · 4mo agoRegulatoryNeutral↗ 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 · 4mo agoRegulatoryNeutral↗ 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 · 4mo 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 · 4mo agoRegulatoryNegative↗ 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 · 4mo agoDealNeutral↗ 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 · 4mo agoDealNeutral↗ 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 · 4mo 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 · 4mo agoRegulatoryNeutral↗ 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 · 4mo agoRegulatoryNeutral↗ source
  • AC Immune CEO Andrea Pfeifer Retires After 23 Years, Company Begins CEO Search
    AC Immune announced that its chief executive Andrea Pfeifer will step down after a 23‑year tenure. Pfeifer, who has guided the biotech through multiple development programs, said she will retire a…
    Endpoints · 4mo agoNeutral↗ source
  • Nonprofits launch Zillow-style marketplace to match abandoned gene and cell therapies with new developers
    Two nonprofit groups announced the launch of an online marketplace designed to give abandoned cell and gene therapy projects a chance for redevelopment. The platform, unveiled at the American Socie…
    Endpoints · 4mo agoPositive↗ source
  • AstraZeneca reports Phase 3 trial shows Imfinzi-Padcev combo improves survival in bladder cancer
    AstraZeneca announced that its Phase 3 study of the immunotherapy Imfinzi combined with the antibody‑drug conjugate Padcev, developed with Pfizer and Astellas, extended overall survival for patient…
    Endpoints · 4mo agoPositive readoutPositive↗ source
  • BeOne Medicines receives accelerated FDA approval for sonrotoclax in mantle cell lymphoma
    BeOne Medicines announced that the U.S. Food and Drug Administration granted accelerated approval to its BCL2 inhibitor sonrotoclax for treatment of mantle cell lymphoma. The approval is based on…
    Endpoints · 4mo agoApprovalPositive↗ source