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370 stories matching this filter · ← front page

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  • 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
  • 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
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fda recalls47
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Infectious Disease353
  • 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
  • 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
  • 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
  • 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
  • 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
  • Q32 Bio’s alopecia drug bempikibart meets Phase 2 goal, driving shares up 80%
    Q32 Bio reported that its experimental alopecia areata therapy, bempikibart, achieved the primary endpoint in the second part of a Phase 2 trial. Two‑fifths of participants grew enough hair to cove…
    BioPharma Dive · 1mo agoPositive readoutPositive↗ source
  • Biotech venture funding hits $9.1 billion in H1 2026, but small startups lag behind
    Venture capital funding for biotech startups surged in the first half of 2026, with nearly 70 companies securing more than $9.1 billion, according to BioPharma Dive data. The bulk of the money cam…
    BioPharma Dive · 1mo agoDealNeutral↗ source
  • ARPA-H awards $160 M to accelerate bespoke gene‑editing therapies for rare diseases
    ARPA-H announced a $160 million, five‑year investment through its THRIVE program to speed the development of personalized gene‑editing treatments for rare genetic conditions. The awardees include…
    BioPharma Dive · 1mo agoNeutral↗ source
  • GSK, Hansoh ADC extends survival in lung cancer study
    GSK claimed the result was a first for an ADC aimed at the “B7-H3” protein, an increasingly popular target of late among cancer drugmakers.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca and Ionis report failure of eplontersen in ATTR-CM trial
    AstraZeneca and Ionis said their nucleic‑acid drug eplontersen did not meet the primary goal in a large study of patients with transthyretin‑mediated amyloid cardiomyopathy (ATTR‑CM). Over a 140‑we…
    BioPharma Dive · 1mo agoNegative readoutNegative↗ source
  • GSK ends $2.2 billion brain drug partnership with Alector after trial failures
    GSK and California‑based biotech Alector have ended their collaboration after both experimental brain drugs failed to meet development milestones. The partnership, announced in July 2021, gave GSK…
    BioPharma Dive · 1mo agoDealNegative↗ source
  • HHS launches Operation Trialblazer to accelerate U.S. drug research amid growing competition from China
    The Department of Health and Human Services introduced a new initiative called Operation Trialblazer aimed at speeding early-stage drug research in the United States. The plan calls for coordinate…
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • Roche scraps two Ionis-partnered Huntington’s drugs
    The Swiss pharmaceutical giant told patient groups tominersen didn't delay disease progression in one trial, while a study of a second drug was scrapped because of a safety signal in animal testing.
    BioPharma Dive · 1mo agoRegulatoryNeutral↗ source
  • AstraZeneca, GSK intensify China ties with Sino Biopharm deals
    The U.K. drugmakers added to a series of recent tie-ups with Chinese counterparts amid broader scrutiny of such transactions in the U.S.
    BioPharma Dive · 1mo ago↗ source
  • Prime wins gene editing dispute; Saol claims latest post-Makary FDA reversal
    An arbitration panel ruled Prime didn’t breach a deal with Beam by developing a rare disease treatment. Elsewhere, European regulators are using a pancreatic cancer drug to test a new framework for…
    BioPharma Dive · 1mo ago↗ source
  • Oberland pours up to $400M into MeiraGTx eye gene therapies
    The funding deal is a vote of confidence in the sales potential of multiple prospects in late-stage development — one of which MeiraGTx recently reacquired from J&J.
    BioPharma Dive · 1mo ago↗ source
  • Kailera says obesity pill succeeds in late-stage trial in China
    The drug spurred about 10% weight loss over 10 months, though that finding came alongside high rates of gastrointestinal side effects that “alarmed” one analyst.
    BioPharma Dive · 1mo ago↗ source
  • Vertex to acquire Crinetics in $10B foray into endocrine disease drugs
    Vertex claimed the two drugs in the deal could eventually bring in more than $5 billion annually. Still, the high price it paid stirred debate among analysts and investors.
    BioPharma Dive · 1mo ago↗ source