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75 stories matching this filter · ← front page

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  • Attovia Therapeutics raises $289 million in IPO to fund antibody-drug research for skin and inflammatory diseases
    Attovia Therapeutics completed an IPO raising $289 million, selling 17 million shares at $17 each and valuing the company at $767 million. Shares will begin trading on Nasdaq under the ticker ATTO.…
    BioPharma Dive · 2h agoDealPositive↗ source
  • J&J pharma chief Jennifer Taubert to retire; Krystal Biotech shares plunge after gene therapy revenue shortfall
    Johnson & Johnson announced that Jennifer Taubert will step down as head of its pharmaceutical division after a 21‑year tenure. During her time she oversaw commercial strategy, dealmaking and the…
    BioPharma Dive · 1d agoNegative↗ source
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fda recalls29
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Vaccines539
Endocrinology & Metabolism307
Ophthalmology283
Infectious Disease270
Pain268
  • Merck's anti-TL1A antibody shows benefit in hidradenitis suppurativa but misses endpoint in rare lung disease trial
    Merck reported mixed results from its anti‑TL1A antibody, a product of its $10.8 billion acquisition of Prometheus Biosciences. In a mid‑stage study for hidradenitis suppurativa, the antibody met…
    Endpoints · 1d agoNeutral↗ source
  • FDA releases new guidances on adhesive performance and skin irritation studies for transdermal generic drugs
    The U.S. Food and Drug Administration has issued two new guidances that address transdermal or topical delivery systems for generic drugs. One is a final guidance that outlines how to assess adhesi…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA issues new guidances on adhesive performance and skin irritation testing for generic transdermal drugs
    The U.S. Food and Drug Administration has released two new guidances that address transdermal and topical delivery systems for generic drugs. One guidance, issued as final, focuses on how manufact…
    raps · 2d agoRegulatoryNeutral↗ source
  • FDA releases new guidances on adhesives and skin irritation testing for transdermal drug products
    The U.S. Food and Drug Administration has issued two new guidances that focus on transdermal and topical delivery systems used for generic medicines. One guidance, finalized, provides recommendati…
    raps · 2d agoRegulatoryNeutral↗ 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 · 5d agoNeutral↗ 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 · 6d agoPositive readoutPositive↗ source
  • Ebola cases approach key milestone as vaccine candidates draw near completion
    The latest update on the Ebola outbreak indicates that the number of cases is approaching a significant threshold, while vaccine development efforts are reported to be close to delivering a usable…
    STAT · 6d agoNeutral↗ source
  • FDA advisory panel reviews Replimune's experimental melanoma therapy RP1
    STAT is live-blogging an FDA Cellular, Tissue, and Gene Therapies Advisory Committee meeting that convened on Thursday to examine Replimune's engineered viral immunotherapy RP1 for melanoma. The p…
    STAT · 6d agoRegulatoryNeutral↗ source
  • A decade after WHO recognition, mycetoma is still one of the world’s most neglected diseases
    Borna Nyaoke-Anoke, a physician leading mycetoma work at the Drugs for Neglected Diseases initiative, reflects on a decade since the World Health Organization formally acknowledged the disease. Sh…
    STAT · 6d agoNegative↗ source
  • Biogen beats revenue expectations, lifts investor confidence with 3% sales rise
    Biogen reported $2.7 billion in revenue for the April‑June quarter, a 3% increase year over year, surpassing analysts' consensus estimate of $2.5 billion. Adjusted earnings per share came in at $3.…
    BioPharma Dive · 7d agoEarningsPositive↗ source
  • Latigo's mid-stage trial shows non-opioid pill LTG-001 cuts post-surgery pain, outperforms placebo
    Latigo Biotherapeutics reported positive Phase 2 data for its experimental oral analgesic LTG-001, tested in patients who had undergone tummy-tuck surgery. The study enrolled 343 participants who w…
    STAT · 6d agoPositive readoutPositive↗ source
  • FDA advisory panel advises against approving Capricor’s Duchenne cell therapy, deramiocel
    The FDA Cellular, Tissue, and Gene Therapies Advisory Committee convened to evaluate deramiocel, a cell‑based treatment for Duchenne muscular dystrophy developed by Capricor Therapeutics. Capricor…
    STAT · 7d agoRegulatoryNegative↗ source
  • Former VA Secretary argues the Veterans Health Administration can boost US biotech competitiveness against China
    The piece, authored by former Veterans Affairs Secretary David Shulkin, positions the VA as a critical component of America’s biotechnology ecosystem alongside HHS and the Department of Defense. H…
    STAT · 7d agoNeutral↗ source
  • Most-wanted fugitive Ronald Fischer operated under alias in biotech industry for two decades
    A Rhode Island man on the most-wanted list was recently uncovered as a hidden employee in the biotech sector, having worked under a false identity for about twenty years. The individual, identifie…
    STAT · 7d agoNegative↗ source
  • GSK CEO outlines £1.9bn cost-saving drive and aims to launch 20 Phase 3 trials by year-end
    GSK chief executive Luke Miels presented a three‑year plan to make the company more agile and generate significant cost efficiencies. The strategy targets £1.9 billion in annual savings by 2029, wi…
    STAT · 8d agoPositive↗ source
  • FDA staff raise concerns over Replimune's skin cancer drug data
    FDA staff have reiterated concerns that Replimune's investigational skin cancer therapy lacks sufficient data for approval. The agency highlighted the single-arm trial, in which patients previousl…
    STAT · 8d agoRegulatoryNegative↗ source
  • New name for PCOS aims to boost awareness and diagnosis for Black and Latina women
    Bontle Moka-Moliki, a 32-year-old from Atlanta, was diagnosed with endometriosis in 2019, fibroids a year later, and in 2024 received a diagnosis of a condition now called polyendocrine metabolic o…
    STAT · 8d agoPositive↗ 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 · 7d agoNegative↗ source
  • Argenx to buy Forte Biosciences for up to $2.2 billion, adding experimental CD122 drug FB102
    Argenx announced it will acquire Forte Biosciences in a transaction valued at up to $2.2 billion. The purchase price is set at $77 per Forte share, roughly a 41% premium to the previous closing pr…
    BioPharma Dive · 9d agoDealPositive↗ source
  • FDA advisory panel votes to expand use of four untested peptides despite safety concerns
    An FDA advisory committee narrowly voted to recommend adding four peptides to the agency's 503A Bulks List, a registry that would allow compounding pharmacies to use them in custom medications. The…
    BioPharma Dive · 12d agoRegulatoryNegative↗ source
  • Sanofi stops development of eczema drug amlitelimab after mixed trial results
    Sanofi announced on Friday that it is halting further development of amlitelimab for atopic dermatitis, a drug it had once promoted as a potential successor to its blockbuster Dupixent. The compan…
    BioPharma Dive · 12d agoNegative↗ source
  • Sanofi halts development of Kymab-derived OX40L antibody for atopic dermatitis
    Sanofi announced that it will no longer pursue the OX40L antibody program it was developing with Kymab for the treatment of atopic dermatitis. The drug was being positioned as a potential follow‑on…
    Endpoints · 12d agoNegative↗ source
  • Arrowhead hits ‘best-case scenario’ with latest results for fat-lowering drug
    To analysts, the drug’s apparent safety and effects on both triglyceride levels and pancreatitis cases should make it competitive with a rival Ionis therapy.
    BioPharma Dive · 14d ago↗ source