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  • FDA pushes Leqembi subcutaneous decision to Aug. 24; Artiva secures $300M and Pharvaris sets pricing
    The U.S. Food and Drug Administration has postponed its review of the subcutaneous formulation of Leqembi. The original target date earlier this month has been moved to August 24, as Biogen and Eis…
    Endpoints · 4mo agoRegulatoryNeutral↗ source
  • Pierre Fabre aligns with FDA on resubmission of Ebvallo cell therapy
    Pierre Fabre Laboratories announced that it has reached an agreement with the U.S. Food and Drug Administration on a new path for its cell therapy Ebvallo, which had been rejected twice. The FDA w…
    BioPharma Dive · 4mo agoRegulatoryNeutral↗ source
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  • Capricor sues Japanese partner over botched Duchenne therapy launch and pricing concerns
    Capricor Therapeutics has filed a lawsuit against its Japanese collaborator Nippon Shinyaku and its subsidiary NS Pharma. The biotech alleges the partners mishandled preparations for the launch of…
    STAT · 4mo agoNegative↗ source
  • Odyssey Therapeutics raises $279 million in IPO, begins Nasdaq trading
    Odyssey Therapeutics, a biotech focused on autoimmune diseases, announced that its initial public offering generated $279 million. The company sold about 15.5 million shares and priced the IPO at…
    Endpoints · 4mo agoDealPositive↗ source
  • Trump reportedly moves to dismiss FDA Commissioner Marty Makary
    President Trump is said to have approved a plan to remove FDA Commissioner Marty Makany, according to several news outlets. The proposed ouster would add to recent turnover in the agency’s senior l…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Capricor sues Nippon Shinyaku over delayed Duchenne drug rollout and pricing formula flaw
    Capricor Therapeutics has filed a lawsuit in New Jersey alleging that Nippon Shinyaku and its US subsidiary NS Pharma have failed to execute agreed upon marketing plans for the company's Duchenne m…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Lilly, Gilead lead pharma’s M&A boom
    Deal volume in 2026 is substantially outpacing last year, and activity is being driven by interest in cancer and autoimmune disease drugs.
    BioPharma Dive · 4mo agoDealNeutral↗ source
  • FDA proposes stripping gender references from regulations, prompting research concerns
    The U.S. Food and Drug Administration has issued a proposal to eliminate references to gender in its regulatory language. The change is intended to modernize the rules but has drawn attention from…
    STAT · 4mo agoRegulatoryNeutral↗ source
  • Aging scientific workforce grapples with rising fabricated citations as hantavirus cruise ship outbreak drags on
    A new analysis highlights that an increasingly senior scientific workforce is coinciding with a surge in fabricated citations across medical journals, raising concerns about research integrity. Th…
    STAT · 4mo agoNeutral↗ source
  • Top young AI researchers avoid careers at large pharmaceutical companies
    Mazdak Abulnaga, a 33‑year‑old postdoctoral fellow at MIT and Harvard Medical School, is highlighted as the type of employee pharmaceutical companies hope to attract this year. Despite the demand,…
    Endpoints · 4mo agoNegative↗ source
  • Natalie Holles appointed CEO after Third Harmonic shutdown; Mark Alles steps down at ADC Biotech
    Natalie Holles quickly found a new role after the decision to wind down operations at Third Harmonic. She has taken over as chief executive, succeeding Elisabet de los Pinos. At the same time, Mar…
    Endpoints · 4mo agoNeutral↗ source
  • Six former FDA officials explain why they left the agency during the Trump era
    STAT's weekly video series STATus Report recently featured a road-trip edition in which reporter Lizzy Lawrence traveled to the Washington suburbs to talk with former FDA staff. The interviews inc…
    STAT · 4mo agoNeutral↗ source
  • Spain prepares to isolate over 140 cruise passengers amid hantavirus outbreak
    Spanish authorities are ready to receive more than 140 passengers and crew from a cruise ship flagged with a hantavirus outbreak as it approaches Tenerife. The vessel is expected to dock on Sunday…
    STAT · 4mo agoNegative↗ source
  • Capricor sues Nippon Shinyaku over pricing dispute for Duchenne cell therapy candidate
    Capricor Therapeutics announced it has filed a lawsuit against its Japanese partner Nippon Shinyaku. The suit alleges a flaw in the pricing terms of the distribution and commercialization agreemen…
    Endpoints · 4mo agoNegative↗ source
  • Calls grow for increased recruitment of men into nursing to address workforce shortages
    Men make up only about 12% of the nursing workforce in the United States. The demand for nurses is rising, with roughly 200,000 job openings expected each year as many current nurses retire. The…
    STAT · 4mo agoPositive↗ source
  • Epidemiologist highlights surge of hantavirus misinformation after cruise ship outbreak
    An outbreak of hantavirus tied to the cruise ship MV Hondius has generated serious health concerns, but online discussion has taken a different turn. Social media users quickly began sharing false…
    STAT · 4mo agoPositive↗ source
  • Immunic appoints Michael Panzara as chief medical officer, coming from Neurvati Neurosciences
    STAT+ columnist Ed Silverman's weekly feature highlights recent personnel changes in pharma. This edition notes a new appointment at Immunic. Immunic has named Michael Panzara its new chief medica…
    STAT · 4mo agoNeutral↗ source
  • Met Gala outfits whimsically matched to biotech logos in annual tradition
    The piece highlights an annual tradition of pairing Met Gala attire with the logos of biotech companies, a playful feature in the STAT newsletter The Readout. For this year’s event, whose theme wa…
    STAT · 4mo agoNeutral↗ source
  • Angelini to acquire Catalyst Pharmaceuticals for $4.1 billion, adding rare CNS drug portfolio
    Angelini Pharma announced it will purchase Catalyst Pharmaceuticals in a cash transaction valued at about $4.1 billion. The agreement pays $31.50 per Catalyst share, representing a 21% premium to…
    BioPharma Dive · 4mo agoDealPositive↗ source
  • Sarepta's Elevidys sales beat forecasts but dip again, prompting stock slide and shift to RNA pipeline
    Sarepta Therapeutics reported that its gene therapy Elevidys generated net product revenue that exceeded Wall Street estimates for the first quarter. However, sales continued to decline compared wi…
    BioPharma Dive · 4mo agoEarningsNegative↗ source
  • EnGene shares tumble 80% after Phase 2 bladder cancer data raise safety concerns
    EnGene, a Canadian biotech firm, released updated Phase 2 results for its experimental therapy aimed at a specific group of bladder cancer patients. The company said the new data fell short of expe…
    Endpoints · 4mo agoNegative readoutNegative↗ source
  • Entrada Therapeutics shares plunge after Duchenne trial shows modest dystrophin increase
    Entrada Therapeutics reported early data from a Phase 1/2 study of its RNA‑based therapy ENTR‑601‑44 for Duchenne muscular dystrophy, noting favorable safety and tolerability. The trial showed a d…
    BioPharma Dive · 4mo agoNegative readoutNegative↗ source
  • Political appointee stalls Sanofi drug approval, raising concerns about FDA interference
    STAT's D.C. Diagnosis newsletter reports that a political appointee is impeding the approval of a Sanofi drug, suggesting direct political interference at the FDA. The article notes that the appoi…
    STAT · 4mo agoRegulatoryNegative↗ source
  • Blackstone invests $250 million in Anagram to address cystic fibrosis complication
    Blackstone Life Sciences announced a $250 million investment in Anagram, a biotech focused on cystic fibrosis complications. The funding is part of one of the largest private investment funds in t…
    Endpoints · 4mo agoDealPositive↗ source
  • Entrada's Duchenne drug shows disappointing early data, shares tumble
    Entrada disclosed initial results from a low‑dose version of its exon‑44 skipping therapy for Duchenne muscular dystrophy. The data, collected from six patients, failed to meet the company’s expect…
    Endpoints · 4mo agoNegative readoutNegative↗ source