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  • ICON audit reveals $65.3M and $92.7M revenue overstatements; Secretome and Psilera announce cash raises
    ICON completed an internal audit that confirmed its reported revenue had been overstated. The audit quantified the overstatement at $65.3 million for 2023, representing about 0.8% of that year's t…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Niowave breaks ground on $75M radioisotope plant in Michigan; CordenPharma to acquire AmbioPharm
    Niowave announced it has started construction of a new radioisotope production facility in Lansing, Michigan, with an investment of about $75 million. The plant will produce radioisotopes used in…
    Endpoints · 3mo agoDealNeutral↗ source
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  • Charles River CEO predicts more manufacturers will spin off cell and gene therapy units
    Charles River Laboratories announced three months ago that it would divest its manufacturing unit dedicated to cell and gene therapy production. CEO Birgit Girshick said the company expects it wil…
    Endpoints · 3mo agoNeutral↗ source
  • China gene-editing startup YolTech secures $70 million funding ahead of Hong Kong IPO plans
    YolTech Therapeutics, a Chinese company focused on CRISPR gene-editing therapies, announced it has closed a $70 million financing round, the largest in its history. The capital will be used to adv…
    Endpoints · 3mo agoDealPositive↗ source
  • Oura expands into health services with launch of smaller Ring 5 wearable
    Oura announced the release of its new Ring 5, a smaller version of its popular health‑tracking ring. Alongside the hardware launch, the company said it will add features that let users link their…
    Endpoints · 3mo agoPositive↗ source
  • Former Legend Biotech co‑founder Frank Fan launches new venture at Wondercel Therapeutics
    Frank Fan, a co‑founder of Legend Biotech, moved from Nanjing to Shenzhen in 2022 in search of a fresh start. After leaving Legend abruptly, he assumed the role of chief executive officer at Wonde…
    Endpoints · 3mo agoPositive↗ source
  • FDA delays AstraZeneca breast cancer drug camizestrant PDUFA date
    The U.S. Food and Drug Administration has extended the PDUFA target date for AstraZeneca’s breast cancer candidate camizestrant, pushing the review timeline back by a few days. No new deadline was…
    Endpoints · 3mo agoRegulatoryNeutral↗ source
  • Acceleron veterans and Westlake back new IPF biotech Oorja Bio with $30 million Series A
    Entrepreneurs who previously brought the drug Winrevair to market have launched a new biotech, Oorja Bio, to target idiopathic pulmonary fibrosis, a hard-to-treat lung disease. The company announc…
    Endpoints · 3mo agoDealPositive↗ source
  • Novo Nordisk streamlines R&D to speed discovery, adds AI to integrated research teams
    Novo Nordisk's new CEO Maziar Mike Doustdar, who took the helm in the summer of 2025, announced a reorganization of the company's R&D structure. Jacob Sten Petersen, head of global research, expla…
    Endpoints · 3mo agoPositive↗ source
  • Full-Life Technologies secures $150M Series D financing
    Full-Life Technologies announced it has raised $150 million in a Series D financing round, comprising $110 million in the main tranche and an additional $40 million. The capital is intended to adv…
    Endpoints · 3mo agoDealNeutral↗ source
  • Relay Therapeutics' zovegalisib meets efficacy endpoint in Phase 2 vascular anomalies trial
    Relay Therapeutics reported that its PI3Kα inhibitor zovegalisib achieved the predefined efficacy threshold in a Phase 2 study of a rare genetic vascular anomaly. The data readout exceeded Wall Str…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • BioMarin's Phase 3 trial of ENPP1 enzyme therapy fails to show benefit
    BioMarin reported that its late-stage study of an enzyme replacement therapy for ENPP1 deficiency did not meet its primary efficacy endpoints. The trial, which enrolled patients lacking the ENPP1 e…
    Endpoints · 3mo agoNegative readoutNegative↗ source
  • Wave Life Sciences reports early-stage data showing monthly dosing possible for RNA editing therapy in AATD
    Wave Life Sciences announced an updated cut of data from its early-stage study of an RNA editing treatment aimed at alpha‑1 antitrypsin deficiency (AATD). The new data suggest the genetic therapy…
    Endpoints · 3mo agoPositive readoutPositive↗ source
  • 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
  • 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