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785 stories matching this filter · ← front page

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  • Takeda's zasocitinib clears scalp psoriasis in 75% of patients in phase 3 data
    Takeda released updated results from its two phase 3 trials of the oral TYK2 inhibitor zasocitinib, enrolling a total of 1,801 patients with moderate-to-severe plaque psoriasis. The data showed th…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • InnoCare’s TYK2 inhibitor soficitinib meets primary endpoint in phase 2 vitiligo trial
    InnoCare Pharma announced that its TYK2 inhibitor soficitinib achieved the primary endpoint in a phase 2 study of non‑segmental vitiligo conducted at sites in China. The trial evaluated daily oral…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
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Psychiatry & CNS727
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Endocrinology & Metabolism390
Infectious Disease364
  • Veradermics' experimental hair loss pill shows promising results in women
    Veradermics reported positive Phase 2 data for its oral minoxidil formulation VDPHL01 in women with mild-to-moderate pattern hair loss. The study enrolled 28 participants who took the drug once or…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • B. Braun pulls spinal anesthesia kits after recall of bupivacaine in dextrose injection
    B. Braun Medical, Inc. has issued a recall of several spinal anesthesia convenience kits that contain Huons bupivacaine hydrochloride in dextrose injection. The recall follows a request from Huons…
    fda medwatch · 1mo agoCRLNegative↗ source
  • Cue Biopharma appoints Dominic Borie as chief medical officer and head of R&D
    Cue Biopharma announced the hiring of Dr. Dominic Borie, MD, PhD, as its new chief medical officer and head of research and development. Borie joins from Kyverna Therapeutics, where he served as a…
    Fierce Biotech · 1mo agoPositive↗ source
  • Arrow International issues correction for convenience kits containing recalled saline, lidocaine and bupivacaine
    Arrow International, a Teleflex subsidiary, sent a correction notice to customers about certain convenience kits. The kits contain 10 mL saline ampules, lidocaine and bupivacaine. The FDA classifi…
    fda medwatch · 1mo agoCRLNeutral↗ source
  • ‘Substantially better than before’: Why India has golden opportunity to build on innovative R&D wins
    A string of recent wins on the frontiers of novel drug development could mean that a homegrown innovation industry is within reach.
    Fierce Biotech · 1mo agoNeutral↗ source
  • Celcuity receives FDA approval for Revtorpyk, a breast cancer therapy, but shares drop nearly 20% amid launch delay concerns
    Celcuity announced that the U.S. Food and Drug Administration cleared its breast cancer drug Revtorpyk for use in combination with hormone therapy and Pfizer's Ibrance in patients with ER-positive,…
    BioPharma Dive · 1mo agoApprovalNegative↗ source
  • Merck's sac-TMT shows promise in Chinese Phase 3 lung cancer trial, may replace chemo
    Merck and its Chinese partner Kelun-Biotech reported that the antibody-drug conjugate sac-TMT slowed disease progression better than a standard chemotherapy regimen in a Phase 3 trial conducted in…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Nobel laureate Jennifer Doudna unveils AI-driven platform to design novel gene‑editing enzymes
    Jennifer Doudna, the Nobel laureate who co‑invented CRISPR, announced a new AI‑powered platform for creating gene‑editing proteins in a paper published today in Science. The system uses computation…
    Fierce Biotech · 1mo agoPositive↗ source
  • Lonza urges biotech firms to prioritize early de-risking to streamline IND path
    In a recent interview, Jaime Okray of Lonza highlighted that emerging biotech companies are shifting focus from pure speed to early identification of development risks as they aim for an IND filing…
    Fierce Biotech · 1mo agoPositive↗ source
  • Agentic AI poised to reshape clinical development by moving beyond tools to autonomous decision-making
    Earlier this year, a colleague argued that clinical leaders should stop asking whether they have an 'AI strategy', because the question often leads to the wrong conversation. Instead, leaders are…
    Fierce Biotech · 1mo agoPositive↗ source
  • J&J shares fall 3% as oncology sales miss forecasts, while AstraZeneca invests $600M in lung cancer drug
    Johnson & Johnson’s stock slipped about 3% on Wednesday even though the company raised its full‑year sales outlook. In its latest quarterly earnings release the firm said revenue in its innovative…
    BioPharma Dive · 1mo agoEarningsNeutral↗ source
  • FDA issues early alert on Resmed Astral ventilators due to electrical component failure risk
    The FDA’s Center for Devices and Radiological Health has released an early alert warning about a possible high-risk problem with certain Resmed Astral ventilators. A defective electrical component…
    fda medwatch · 1mo agoRegulatoryNegative↗ source
  • Attovia Therapeutics and Braveheart Bio announce plans for biotech IPOs amid market upswing
    Attovia Therapeutics and Braveheart Bio disclosed on Tuesday that they intend to go public, joining a recent wave of large biotech offerings. Attovia, which was spun out of Alamar Biosciences in 2…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Axiom's stem cell therapy shows zero mortality in phase-1 trial for newborn brain injuries
    Axiom Biosciences reported that its mesenchymal stem cell (MSC) therapy achieved a 0% mortality rate over two years in a phase‑1 study of newborns with severe brain injuries. The nine‑patient trial…
    Fierce Biotech · 1mo agoPositive readoutPositive↗ source
  • CVS Caremark settles FTC antitrust case, agreeing to favor lowest-cost insulin on formularies
    CVS Caremark announced a settlement with the Federal Trade Commission that resolves the agency’s antitrust lawsuit alleging the PBM favored higher-priced insulin versions. Under the agreement, Car…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Avere Therapeutics to go public via reverse merger, secures $320M to advance long-acting psoriasis pill
    Avere Therapeutics, a privately held immunology drug developer, announced a plan to become a public company through a reverse merger with NextCure. The transaction includes $320 million in new cap…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Biogen's tau-targeting Alzheimer's drug shows cognitive slowing in mid-stage trial
    Biogen reported results from its mid-stage "Celia" trial testing the experimental tau-targeting antibody BIIB080 in patients with early Alzheimer's disease. The study compared three dose levels of…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Draig Therapeutics secures $65M Series B to advance brain-drug trials
    Draig Therapeutics announced a $65 million Series B financing led by Deep Track Capital, with participation from Janus Henderson Investors, Marshall Wace and other investors. The capital will fund…
    BioPharma Dive · 1mo agoDealPositive↗ source
  • Cayman court orders Apple Tree Partners’ general partner to give up control of venture fund
    A Cayman Islands court ruled that Seth Harrison, the general partner of biotech venture firm Apple Tree Partners, must relinquish oversight of the fund. The order could shift management to two cour…
    BioPharma Dive · 1mo agoRegulatoryNegative↗ source
  • Baxter issues urgent correction for Volara breathing device circuits due to leak risk
    Baxter has sent an Urgent Medical Device Correction notice to customers using its Volara Positive Pressure Breathing System, advising that all patient circuits be corrected before further use. The…
    fda medwatch · 1mo agoCRLNegative↗ source
  • BIO 2026 in San Diego features executive interviews on biotech trends and opportunities
    The BIO International Convention gathered more than 20,000 life‑science leaders in San Diego, serving as a major forum for biotech discussion. During the event, Fierce conducted a series of video…
    Fierce Biotech · 1mo agoNeutral↗ source
  • Agenus redirects late-stage colorectal trial to pre-surgery setting, shares double; Oxford Ebola vaccine enters Phase 1
    Agenus announced it will stop financially supporting its late-stage trial of the BOT+BAL immunotherapy combination in late-line colorectal cancer. The company will instead use recent $340 million…
    BioPharma Dive · 1mo agoNeutral↗ source
  • Freenome's updated blood test shows stronger detection of precancerous lesions, boosting Abbott's market prospects
    Freenome announced that its revised SimpleScreen CRC blood test met both primary and secondary goals in a pivotal validation study. The new data indicate better performance than the earlier version…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source