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  • Anthony Fauci’s pandemic-era diary entries
    New data on American substance use, concerns of a global HIV resurgence, and more health news from Morning Rounds
    STAT · 1d agoRegulatoryNeutral↗ source
  • Apnimed eyes up to $160M IPO to prep for sleep apnea drug launch
    If the offering closes, Apnimed will join the 2026 IPO class that has already far surpassed last year’s total.
    BioSpace · 1d agoRegulatoryNeutral↗ source
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  • Oak Hill takes SPAC track to Nasdaq with Roche asset in tow
    Oak Hill Bio is developing the antisense therapy rugonersen, which it licensed from Roche in 2025, for Angelman syndrome.
    BioSpace · 1d agoRegulatoryNeutral↗ 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 · 1d agoRegulatoryNeutral↗ source
  • Opinion: STAT+: Dementia finally has a business model
    The big takeaway from the recent Alzheimer’s Association International Conference in London is an economic message: Dementia finally has a business model, writes Jason Karlawish.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: From ‘lost cause’ to gold rush: Biotechs swarm to cure AATD
    Biotech companies are racing to cure alpha-1 antitrypsin deficiency, AATD, fueling patent disputes, startup defections, arbitration, and a U.S.-China rivalry.
    STAT · 1d agoRegulatoryNeutral↗ source
  • STAT+: CMS evaluates one year of health tech progress, announces eight new pledge categories
    One year after launching the CMS Health Tech Ecosystem, officials convened in D.C. to celebrate the Trump administration modernizing health technology.
    STAT · 1d 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 · 12h agoNegative↗ source
  • WHO publishes first interim list of 12 medical device regulators eligible for WHO-listed authority status
    The World Health Organization has released its first interim list of medical device regulators that can attain WHO-listed authority status. The list names 12 regulators from different regions that…
    raps · 1d agoRegulatoryNeutral↗ source
  • Eli Lilly tops new biopharma ranking on launch success, development speed
    Flush with GLP-1 cash and pipeline success, Eli Lilly rose from 16th to first over five years in Norstella’s inaugural Pipeline-to-Patient Productivity Index, which evaluated 25 large, global bioph…
    Fierce Biotech · 23h agoNeutral↗ source
  • Incyte ditches phase 1-stage JAK inhibitor to pursue next-gen options
    Incyte has ditched a JAK2 inhibitor in phase 1 development for a rare blood cancer in favor of “next-generation” replacements.
    Fierce Biotech · 1d agoNeutral↗ source
  • Altimmune’s next-gen GLP-1 curbs heavy drinking in ‘unequivocal’ ph. 2 alcohol use disorder win
    An experimental drug targeting both GLP-1 and glucagon receptors has curbed heavy drinking in a phase 2 trial, providing hope that the ubiquitous weight loss meds can be effectively harnessed again…
    Fierce Biotech · 1d agoNeutral↗ source
  • GSK unveils 3-year cost-saving plan to fund late-stage R&D, move research HQ to AZ's backyard
    GSK has unveiled an ambitious three-year plan to divert resources to its late-stage R&D programs and shift its research headquarters—but CEO Luke Miels is being tight-lipped about the extent of any…
    Fierce Biotech · 1d agoNeutral↗ source
  • Atea’s hepatitis C asset matches Gilead’s Epclusa in phase 3 trial
    Atea Pharmaceuticals’ hepatitis C prospect has matched Gilead’s Epclusa in a phase 3 trial, keeping the biotech barreling toward a second readout for its shorter, simpler treatment regimen.
    Fierce Biotech · 1d agoNeutral↗ source
  • Acrosian debuts as AI-focused biometrics CRO
    The founders of contract research organization Quartesian have reunited to form Acrosian, a CRO designed to be purpose-built for the AI era.
    Fierce Biotech · 1d agoNeutral↗ source
  • Guardant Health taps Patrick Dempsey for emotional colorectal cancer awareness video
    Colorectal cancer blood test maker Guardant Health has teamed up with “Grey’s Anatomy” star Patrick Dempsey for a new, highly emotional video.
    Fierce Biotech · 1d agoNeutral↗ source
  • GSK partner Hansoh reports another phase 3 win for priority ADC
    Hansoh Pharmaceutical has guided its GSK-partnered, B7-H3-directed antibody-drug conjugate to another phase 3 win in China.
    Fierce Biotech · 1d agoNeutral↗ source
  • Otsuka’s ADHD approval opens up new drug class with $615M opportunity
    Otsuka Pharmaceutical plans to launch Simtriyo—the first norepinephrine, dopamine, serotonin reuptake inhibitor—later this year following scheduling by the U.S. Drug Enforcement Agency.
    BioSpace · 1d agoApprovalPositive↗ source
  • FDA approves Freenome colorectal cancer blood test to be marketed by Abbott
    The FDA has approved Freenome’s new blood-based colorectal cancer test, SimpleScreen CRC, which Abbott will exclusively market in the U.S.
    Fierce Biotech · 2d agoApprovalPositive↗ source
  • UPDATE: FDA disputes Capricor's claims of Phase 3 success for DMD cell therapy
    In briefing documents published Monday ahead of an advisory committee meeting for deramiocel, the FDA disagreed with Capricor's assertion that a Phase 3 trial met its primary outcome measures.
    BioSpace · 1d agoPositive readoutPositive↗ source
  • InnoCare’s oral TYK2 inhibitor clears phase 3 psoriasis test
    InnoCare Pharma announced Monday that its oral tyrosine kinase 2 (TYK2) inhibitor fadeucravacitinib met the primary endpoint in a phase 3 trial of adults with moderate-to-severe plaque psoriasis.
    Fierce Biotech · 2d agoPositive readoutPositive↗ 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 · 2d agoNegative readoutNegative↗ source
  • AstraZeneca execs ‘very confident’ in homegrown ADC pipeline despite scrapping 2 candidates
    AstraZeneca executives told Fierce they are “very confident” in the pharma’s in-house pipeline of ADCs despite scrapping two candidates that underperformed in the clinic.
    Fierce Biotech · 2d agoNegative readoutNegative↗ source
  • Lilly, AbbVie and others pursue in-vivo CAR-T, but safety concerns loom
    Analysts at H.C. Wainwright say safety will be the decisive factor for in‑vivo CAR‑T therapies, noting that convenience and efficacy alone will not win over investors. In‑vivo CAR‑T aims to genera…
    BioSpace · 2d agoNeutral↗ source
  • Summit Therapeutics reports positive Phase 3 data for lung cancer drug ivonescimab, highlighting regulatory hurdles for US approval
    Summit Therapeutics and its Chinese partner Akeso announced that their PD-1/VEGF antibody ivonescimab showed positive results in a Phase 3 trial for non-small cell lung cancer in Western patients.…
    BioSpace · 2d agoPositive readoutPositive↗ source