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2,105 stories matching this filter · ← front page

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  • Definium’s oral LSD candidate DT120 shows strong anxiety reduction in Phase 3 trial
    Definium Therapeutics reported that its single‑dose oral LSD candidate DT120 achieved a statistically significant reduction in anxiety symptoms in a Phase 3 study of generalized anxiety disorder. T…
    BioSpace · 45m agoPositive readoutPositive↗ source
  • BridgeBio’s ATTR drug Attruby posts strong Q2 sales surge as Alnylam trims Amvuttra outlook
    BridgeBio Pharma reported that its transthyretin amyloidosis treatment Attruby generated $222.4 million in second‑quarter sales, more than triple the $71.5 million earned in the same period a year…
    BioSpace · 3h agoEarningsPositive↗ source
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fda recalls36
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fda press24
Vaccines685
Psychiatry & CNS653
Endocrinology & Metabolism331
Ophthalmology329
Pain316
Infectious Disease305
  • Replimune secures FDA approval for RP1 therapy in advanced melanoma as Eli Lilly reports strong Q2 earnings
    Replimune announced that the FDA has granted market approval for its oncolytic immunotherapy RP1, aimed at treating advanced melanoma. The decision follows two earlier rejections and a contentious…
    BioSpace · 4h agoApprovalPositive↗ source
  • Neurocrine's Prader-Willi drug Vykat XR linked to multiple deaths and serious side effects
    A group of physicians and experts in Prader-Willi syndrome warned clinicians about safety concerns with Vykat XR, a drug approved by the FDA in March 2025 to reduce the intense hunger in patients w…
    STAT · 6h agoRegulatoryNegative↗ source
  • Definium's LSD pill shows significant anxiety reduction in Phase 3 trial
    Definium Therapeutics announced results of a Phase 3 trial testing its LSD‑based pill DT120 in patients with generalized anxiety disorder. The study enrolled 214 participants who received a single…
    STAT · 2h agoPositive readoutPositive↗ source
  • Sentynl inks up to $475M licensing deal to commercialize Mereo’s alvelestat for rare lung disease
    Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, signed an agreement to obtain exclusive U.S. rights to market alvelestat, Mereo BioPharma’s investigational therapy for alpha-1 antitrypsin…
    BioSpace · 3h agoDealPositive↗ source
  • Eli Lilly sues six U.S. entities over illegal retatrutide sales, urges broader crackdown
    Eli Lilly announced legal action against six U.S. entities accused of selling its experimental obesity drug retatrutide on the black market. The lawsuits target compounding pharmacies, medical spa…
    BioSpace · 1h agoRegulatoryNeutral↗ source
  • Definium's oral LSD candidate passes first Phase 3 trial in generalized anxiety disorder
    Definium Therapeutics announced that its oral LSD candidate has successfully completed a Phase 3 trial in generalized anxiety disorder. The study met its primary endpoints, marking the first of tw…
    Endpoints · 3h agoPositive readoutPositive↗ source
  • Boulevard Bio raises $65M to expand immunology pipeline, eyes Vera's IgAN candidate
    Boulevard Bio announced it has secured $65 million in financing to broaden its immunology portfolio. The new capital will support the development of two immune‑resetting drugs the company discovere…
    Endpoints · 4h agoDealPositive↗ source
  • Samsung gets FDA clearance for Galaxy Buds hearing-aid features
    Samsung Electronics received FDA clearance for new software features in its Galaxy Buds earphones that let them function as over-the-counter hearing aids and conduct hearing tests. The hearing tes…
    Fierce Biotech · 6h agoApprovalPositive↗ source
  • AI-focused biotech firms drive biopharma toward a 'fail-fast' drug development model
    AI is quickly becoming a central force in drug development as tech capital pours into biopharma, reshaping how new medicines are discovered. Tyrone Lam, chief business officer at GATC Health, says…
    BioSpace · 9h agoPositive↗ source
  • Commure's AI-driven referral program draws complaints of financial losses from health-care customers
    Commure, a Silicon Valley startup valued at $7 billion, builds AI tools aimed at automating health‑care administrative work such as scheduling, billing and prior‑authorization. According to intern…
    STAT · 6h agoNegative↗ source
  • Climate change worsens symptoms for people with chronic illnesses, author reports from Chicago smoke events
    The author argues that climate change is already harming health, particularly for those living with chronic conditions, and that the impact is becoming more evident. She describes a recent summer…
    STAT · 6h agoNegative↗ source
  • Renowned autoimmune researcher Georg Schett co-founds biotech to develop antibody therapies
    Georg Schett, a German scientist noted for pioneering CAR‑T approaches in autoimmune disease, is now launching a new biotech venture. The startup, which has not yet been named in the report, will…
    STAT · 4h agoDealPositive↗ source
  • Inside a Secret AI Startup: Challenges of Building and Selling Clinical Tools
    The STAT+ newsletter reveals that a health‑tech reporter has been quietly developing an artificial‑intelligence startup for the past six months. The piece describes the difficulties of rapidly cre…
    STAT · 2h agoNeutral↗ source
  • Missed promotion often reflects organizational timing, not personal failure
    A missed promotion can feel like a verdict on one’s potential, yet the source notes that employees and organizations often develop at different speeds. Executive coach Angela Justice recounts a ca…
    BioSpace · 7h agoNeutral↗ source
  • 7 companies hiring in North Carolina now
    Looking for a biopharma job in North Carolina? Job postings in the area have increased. Here are seven companies with open roles.
    BioSpace · 1h ago↗ source
  • STAT+: Pharmalittle: We’re reading about Lilly ‘black market’ lawsuits, pushback over Trump vaccine plan, and more
    Eli Lilly filed six lawsuits against U.S. companies it accuses of illegally selling black-market versions of its experimental obesity drug retatrutide
    STAT · 1h ago↗ source
  • After slimming down workforce, Aardvark scraps phase 3 trials as wait for next steps drags on
    Aardvark Therapeutics has confirmed it is walking away from recently terminated phase 3 trials, telling investors it has no plans to resume the studies “as previously designed” as it works to find…
    Fierce Biotech · 5h ago↗ source
  • Definium's LSD-based therapy shows strong Phase 3 results in generalized anxiety disorder
    Definium Therapeutics reported that its LSD-derived oral tablet, DT120, met its primary endpoint in a Phase 3 trial for generalized anxiety disorder. The study enrolled over 200 participants and co…
    Fierce Biotech · 21h agoPositive readoutPositive↗ source
  • Eli Lilly fronts $2 billion for vaccine biotech deals as Infinimmune secures $75 million funding
    Eli Lilly announced it has paid $2 billion up front as part of its ongoing strategy to acquire vaccine‑focused biotechnology companies, a portion of a larger deal that could total up to $3.8 billio…
    Endpoints · 1d agoDealPositive↗ source
  • Medicaid to End Funding for Gender-Affirming Surgeries and Hormone Therapy for Transgender Youth
    The Trump administration announced that Medicaid will no longer cover gender-affirming surgeries and hormone treatments for minors. The change also applies to the Children’s Health Insurance Progr…
    STAT · 16h agoRegulatoryNegative↗ source
  • Combination therapy including leronlimab clears HIV in infant macaques, offering new cure hope
    CytoDyn researchers tested leronlimab together with broadly neutralizing antibodies and antiretroviral therapy in a cohort of 55 infant macaques. Only the eight animals that received the full three…
    Fierce Biotech · 19h agoPositive readoutPositive↗ source
  • Health industry pushes back against Trump’s vaccine executive order
    President Trump signed an executive order this week that would overhaul the federal childhood‑vaccination program, calling for fewer shots administered over a longer period. The order specifically…
    STAT · 21h agoRegulatoryNegative↗ source
  • Insilico Medicine CEO touts billions in pipeline deals at BIO International Convention
    At the BIO International Convention in June, Insilico Medicine chief Alex Zhavoronkov made a high‑energy appearance that attracted considerable attention. Zhavoronkov handed out a postcard‑sized l…
    BioSpace · 1d agoDealPositive↗ source