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79 stories matching this filter · ← front page

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  • 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 · 2h agoEarningsNegative↗ source
  • Pfizer reports Phase 3 success for Litfulo in vitiligo trials; Braveheart and Attovia target $275M and $182M IPOs
    Pfizer announced that its experimental drug Litfulo achieved Phase 3 success in two separate studies targeting active and stable nonsegmental vitiligo, an autoimmune condition that causes loss of s…
    Endpoints · 7h agoPositive readoutPositive↗ source
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Endocrinology & Metabolism94
Nephrology71
  • 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 · 9h agoRegulatoryNegative↗ source
  • Attovia, Braveheart and Vogenx seek more than $500M across trio of IPOs
    Attovia Therapeutics, Braveheart Bio and Vogenx have set target ranges for their IPOs, positioning the trio to collectively net more than $500 million from public investors.
    Fierce Biotech · 14h ago↗ source
  • Labcorp posts higher Q2 earnings on strength of diagnostics, lab services; adjusts full-year guidance
    Labcorp continues to power along as it posts strong quarterly earnings led by growth in its diagnostics and lab services and triggering the medtech to raise its full-year guidance.
    Fierce Biotech · 14h ago↗ source
  • Boston Scientific cuts guidance again after unveiling restructuring plan
    Boston Scientific is cutting its financial guidance for the second quarter in a row as it gears up for a tough six months ahead.
    Fierce Biotech · 19h ago↗ source
  • FDA advisory panel rejects Capricor’s Duchenne cardiomyopathy cell therapy
    A FDA advisory committee voted against Capricor’s cell therapy for Duchenne muscular dystrophy cardiomyopathy, with nine members opposing and three supporting the product. The therapy, called dera…
    Fierce Biotech · 1d agoRegulatoryNegative↗ source
  • FDA advisory panel rejects Capricor's Duchenne heart-cell therapy deramiocel
    An FDA advisory committee voted 9-3 to reject Capricor Therapeutics' experimental cell therapy deramiocel for Duchenne-related cardiomyopathy. The panel said the data did not provide substantial ev…
    BioPharma Dive · 1d agoRegulatoryNegative↗ source
  • STAT+: FDA expert panel recommends against approval of Capricor’s Duchenne drug
    STAT is live-blogging an FDA meeting on Capricor Therapeutics’ treatment for Duchenne muscular dystrophy, which has been the subject of a contentious regulatory review.
    STAT · 1d agoRegulatoryNeutral↗ source
  • Earnings roundup: Biogen’s ‘resiliency,’ AstraZeneca’s growth pitch and GSK’s oncology push
    Better-than-expected sales helped Biogen regain the support of investors, while AstraZeneca and GSK worked to convince Wall Street that they can hit ambitious revenue targets.
    BioPharma Dive · 1d agoEarningsNeutral↗ source
  • After PCOS became PMOS, there’s hope for new awareness among Black and Latina women
    Growing awareness of a painful endocrine disorder now named PMOS is good news for women of color, who have high prevalence and low diagnosis.
    STAT · 2d agoRegulatoryNeutral↗ source
  • ADA faces member backlash and calls for CEO and CSO resignations after expert expulsions
    The American Diabetes Association’s 2026 Scientific Sessions in New Orleans ended with the expulsion of five diabetes experts, sparking a wave of criticism. More than 200 members signed an open le…
    STAT · 1d agoNegative↗ source
  • After missed endpoint, Gossamer and Chiesi pull the plug on PAH drug collaboration
    After signing a deal worth up to $486 million with Italian biopharma Chiesi to develop its pulmonary arterial hypertension (PAH) candidate seralutinib in 2024, Gossamer Bio has ended the collaborat…
    Fierce Biotech · 3d agoNegative readoutNegative↗ source
  • Labcorp unveils direct-to-consumer genetic health panel covering 163 genes and 100+ conditions
    Labcorp announced the launch of a new direct-to-consumer test called the Marker by Labcorp Genetic Health Panel. The panel examines 163 genes to assess risk for more than 100 hereditary conditions…
    Fierce Biotech · 3d agoPositive↗ source
  • STAT+: Ahead of hearing, FDA questions the efficacy of Capricor’s Duchenne drug
    Ahead of a hearing, the FDA raised questions about the benefits of a Duchenne treatment from Capricor Therapeutics, another twist for the rare disease drug.
    STAT · 3d agoRegulatoryNeutral↗ source
  • STAT+: Fatal gene-editing trial in China raises ethics and oversight questions
    Sanofi insulin pen in short supply, a win for peptide compounds, and more biotech news from The Readout
    STAT · 6d ago↗ source
  • Scribe records upsized $129M IPO to bankroll lipid-lowering genetic meds
    In vivo gene editing outfit Scribe Therapeutics has priced its IPO at $128.7 million, surpassing the $96 million goal set out earlier this week.
    Fierce Biotech · 6d ago↗ source
  • Lilly, with new data, to seek FDA approval of obesity drug retatrutide
    The new findings position Lilly to file an application for the highly anticipated medicine, but also leave some questions about the additive benefits a “triple-G” drug has on heart health.
    BioPharma Dive · 7d ago↗ source
  • FDA panel confronting peptide controversy
    Today's biotech news features the FDA weighing the fate of peptides; approvals for RevMed, GSK; and data on Lilly's "triple-G."
    STAT · 7d ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly obesity drug data, a push for FDA to ban DTC ads, and more
    A study of Lilly's retatrutide weight loss drug in people with heart disease did not answer a crucial question — whether it reduces cardiovascular risk
    STAT · 7d ago↗ source
  • STAT+: New data on Eli Lilly’s ‘triple-G’ drug leave open questions on heart benefit
    On analyses that looked at major cardiovascular events, those taking retatrutide did not have a significant lower risk of death, heart attack, or stroke.
    STAT · 7d ago↗ source
  • Lilly’s triple-G drug hits 22.6% weight loss, but impact on reducing cardio risk is less clear
    Eli Lilly’s triple-G drug retatrutide has hit the primary endpoints of a pair of phase 3 obesity trials, although the peak weight loss fell short of previous trials while failing to prove the drug…
    Fierce Biotech · 7d ago↗ source
  • FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot
    The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot.
    fda press · 8d ago↗ source
  • Summit counters PD-1/VEGF skeptics; Celldex drug fails skin disease study
    A new analysis could address some doubts investors have had about ivonescimab, one analyst said. Elsewhere, Gilead and Merck debuted data for a once-weekly HIV tablet and a new pyschedelics competi…
    BioPharma Dive · 8d ago↗ source
  • Crystalys nets $130M more to push gout drug through late-stage tests
    The startup has a broad global development program underway — and the support of more than 20 investment firms — for a treatment that’s approved in many Asian countries but isn’t yet available in t…
    BioPharma Dive · 8d ago↗ source