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  • Moderna sticks to 10% revenue growth goal despite Phase 3 norovirus vaccine miss
    Moderna said it will continue to aim for up to 10% revenue growth this year, even though its experimental norovirus vaccine did not achieve statistical significance in a Phase 3 interim analysis.…
    BioSpace · 19d agoNegative readoutNeutral↗ source
  • Novo Nordisk's anti-inflammatory drug ziltivekimab fails to cut major heart events in Phase 3 trial
    Novo Nordisk reported that its investigational anti‑inflammatory antibody, ziltivekimab, did not reduce the incidence of major cardiovascular events in a pivotal Phase 3 study. The trial enrolled…
    STAT · 20d agoNegative readoutNegative↗ source
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  • AbbVie shares slip 4% as Q2 immunology earnings beat falls short of lofty expectations
    AbbVie’s stock fell about 4% on Friday after the company reported second‑quarter results that modestly exceeded analyst forecasts, disappointing investors who had set very high expectations. The f…
    BioSpace · 19d agoEarningsNegative↗ source
  • Sanofi CEO pledges to rebuild trust and expand partnership with Regeneron
    Sanofi's new chief executive, Belén Garijo, told analysts that restoring the relationship with longtime partner Regeneron is a top priority. She said the company wants to be more transparent and to…
    BioPharma Dive · 19d agoNeutral↗ source
  • FDA advisory panel backs experimental Replimune melanoma therapy after two prior rejections
    An FDA advisory committee voted 10‑to‑3 to recommend the use of an experimental Replimune treatment for patients with advanced melanoma. The panel’s recommendation marks a shift after the agency p…
    STAT · 19d agoPositive readoutPositive↗ source
  • UniQure prepares for FDA advisory committee on Huntington’s gene therapy amid rare-disease regulatory jitters
    UniQure said it is ready to present its Huntington's disease gene therapy, AMT-130, to an FDA advisory committee, as discussed in its Q2 earnings call. The company expects the FDA may schedule the…
    BioSpace · 20d agoRegulatoryNeutral↗ source
  • Trump administration proposes 340B rebate pilot for 2027, hospitals push back
    The Health Resources and Services Administration announced a new pilot that would shift some 340B drug discounts to rebate payments starting in 2027. The proposal follows a previous attempt earlie…
    BioPharma Dive · 19d agoRegulatoryNegative↗ source
  • Trump administration revises 340B rebate pilot, sparking hospital backlash
    The Health Resources and Services Administration announced a revision to the 340B drug pricing program’s rebate pilot, slated to begin on Jan 1, 2027. Under the new rules, participating manufactur…
    STAT · 19d agoRegulatoryNegative↗ source
  • Senate advances Erica Schwartz’s CDC director nomination to full Senate vote
    The Senate Health Committee approved Erica Schwartz as the nominee for CDC director, securing bipartisan support that included every Republican member and Democrat Tim Kaine. With the committee’s…
    STAT · 20d agoRegulatoryNeutral↗ source
  • Opinion: Limb girdle muscular dystrophy patients face a maddening reality
    “Too often, regulatory tools authorized to speed patient access to breakthrough treatments are being used in ways that even prevent approval,” writes Kat Bryant Knudson.
    STAT · 20d agoRegulatoryNeutral↗ source
  • Syphilis cases rise among unhoused drug users at San Diego-Tijuana border as researchers face NIH limits and penicillin shortage
    Researchers at the University of California San Diego have been working for years to build trust with unhoused people who use drugs on both sides of the San Diego‑Tijuana border. Their outreach has…
    STAT · 20d agoNegative↗ source
  • ADA’s reputation erodes after controversial physician expulsions at annual meeting
    In a recent opinion piece, Adam Marcus and Ivan Oransky reflect on how their view of the American Diabetes Association (ADA) has shifted. Nine years ago they lauded the organization for defending a…
    STAT · 20d agoNegative↗ source
  • Authors rebut mischaracterization of their 2023 Lancet Covid study in recent op-ed
    The authors of a 2023 Lancet analysis on the United States Covid response wrote to correct a recent First Opinion piece that they say misrepresented their work. While they welcome calls for additio…
    STAT · 20d agoNegative↗ source
  • Bexorg names Bruce Car as new chief scientific officer
    Bexorg announced the appointment of Bruce Car as its chief scientific officer, according to a recent STAT+ column that tracks personnel moves in the pharmaceutical sector. Car joins Bexorg to lead…
    STAT · 19d agoPositive↗ source
  • Alnylam shares tumble nearly 30% after cutting revenue outlook for key amyloidosis drugs
    Alnylam Pharmaceuticals saw its market value drop about 30%, roughly $12 billion, after it lowered its revenue forecast for its leading amyloidosis treatments. The company had previously expected…
    BioPharma Dive · 20d agoEarningsNegative↗ source
  • Johnson & Johnson secures option to acquire in-vivo CAR-T developer Sail Biomedicines for up to $2.6 billion
    Johnson & Johnson announced a strategic partnership with Sail Biomedicines, a Flagship Pioneering‑backed startup, that includes an upfront cash payment and an equity investment. The initial paymen…
    BioPharma Dive · 20d agoDealPositive↗ source
  • BMS beats Q2 forecasts and lifts 2026 outlook despite delays in Cobenfy and milvexian data
    BMS reported second‑quarter revenue of $12.97 billion, topping analysts' estimate of $11.73 billion, and earnings per share of $2.04, well above the $1.60 consensus. The strong results prompted the…
    BioSpace · 20d agoEarningsNeutral↗ source
  • J&J strikes up to $925M deal with Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson announced a collaboration with Flagship Pioneering’s Sail Biomedicines to develop in vivo CAR‑T therapies for immune‑mediated diseases. The agreement provides up to $925 million i…
    BioSpace · 21d agoDealNeutral↗ source
  • FDA advisory panel backs Replimune's melanoma therapy RP1, raising approval prospects
    Advisors to the U.S. Food and Drug Administration voted 10-3 in favor of Replimune's experimental melanoma treatment, RP1, despite lingering scientific concerns about the data presented. The panel…
    BioPharma Dive · 20d agoRegulatoryPositive↗ source
  • FTC Sues Hims & Hers for Alleged Illegal Sharing of Patient Data and Deceptive Billing
    The Federal Trade Commission has filed a lawsuit against Hims & Hers, a California‑based telehealth company, accusing it of violating privacy laws. The complaint says the firm used tracking pixels…
    BioPharma Dive · 20d agoRegulatoryNegative↗ source
  • Analysts say Daiichi Sankyo’s ADC pipeline lags rivals as cash flow peaks, cutting expectations
    Jefferies analysts warned that Daiichi Sankyo's early‑stage antibody‑drug conjugate (ADC) pipeline is falling behind competitors, even as the company approaches a peak in cash flow from its existin…
    BioSpace · 20d agoNegative↗ source
  • FDA advisory panel backs Replimune’s melanoma immunotherapy combined with Opdivo
    The FDA’s Cellular, Tissue and Gene Therapies advisory committee voted 10-3 to recommend Replimune’s RP1 immunotherapy, used together with Bristol Myers Squibb’s Opdivo, for patients with advanced…
    BioSpace · 20d agoRegulatoryPositive↗ source
  • Regeneron defends M&A stance as cash hoard reaches $18 billion amid trial setbacks
    Analysts on Regeneron's second‑quarter earnings call questioned the company's lack of merger and acquisition activity, pointing to an $18 billion cash reserve and recent clinical trial setbacks. C…
    BioSpace · 20d agoEarningsNeutral↗ source
  • Rising oil prices could lift manufacturing costs of an HIV drug, Unitaid report says
    Rising oil prices, driven in part by geopolitical tensions, have raised concerns about the stability of medicine supply chains. Analysts note that higher energy costs can translate into increased p…
    STAT · 20d agoNeutral↗ source
  • FDA panel rejects Capricor's Duchenne drug, citing insufficient efficacy data
    The U.S. Food and Drug Administration advisory committee voted 9-to-3 against a Capricor Therapeutics candidate for Duchenne muscular dystrophy. The panel said the clinical data did not provide sub…
    STAT · 20d agoRegulatoryNegative↗ source