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  • FDA acting commissioner says Makary’s journal policies are not official guidance; UK regulator reports rise in drug approvals and AI steps
    The acting commissioner of the U.S. Food and Drug Administration clarified that the policies published in medical journals by former commissioner Marty Makary do not constitute official FDA policy…
    raps · 1mo agoRegulatoryNeutral↗ 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
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  • 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
  • Experts say MDUFA VI draft letter improves program while addressing FDA resource limits
    Industry experts note that the draft commitment letter for the upcoming Medical Device User Fee Amendments (MDUFA VI) offers enhancements over the current framework and takes into account the FDA’s…
    raps · 2mo agoRegulatoryNeutral↗ 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 · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo agoPositive readoutPositive↗ source
  • Medtronic recalls Harmony delivery catheter system after tip detachment risk
    Medtronic has issued a recall of certain lots of its Harmony Delivery Catheter System (DCS), which is used to implant the Harmony transcatheter pulmonary valve. The FDA classified the recall as th…
    fda medwatch · 2mo agoCRLNegative↗ 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo 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 · 2mo agoRegulatoryNeutral↗ source
  • FDA issues early alert on non‑sterile BD ChloraPrep applicators in Medline convenience kits
    FDA CDRH issued an early alert about a potentially high‑risk device issue involving BD ChloraPrep applicators in Medline convenience kits that may not be sterile. Medline sent a letter on June 12…
    fda medwatch · 2mo agoRegulatoryNegative↗ 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 · 2mo agoRegulatoryNeutral↗ source
  • Medical Action Industries issues recall of convenience kits due to risk of particulate contamination
    The FDA’s Center for Devices and Radiological Health issued an early alert about a potential high‑risk issue with a Medical Action Industries convenience kit. The alert says that particulates coul…
    fda medwatch · 2mo agoCRLNegative↗ source
  • AstraZeneca and GSK strike new China partnerships with Sino Biopharm
    Sino Biopharm announced two separate agreements with the United Kingdom's largest drugmakers, AstraZeneca and GSK, to deepen their presence in the Chinese market. AstraZeneca will license rights t…
    BioPharma Dive · 2mo agoDealPositive↗ source
  • Arbitration panel rules Prime Medicine did not breach Beam deal over AATD therapy
    An arbitration panel has ruled that Prime Medicine did not violate its 2019 collaboration agreement with Beam Therapeutics by advancing a treatment for alpha‑1 antitrypsin deficiency (AATD). The de…
    BioPharma Dive · 2mo agoNeutral↗ source
  • FDA grants accelerated approval to Vera Therapeutics' Trutakna for IgA nephropathy
    The FDA has granted accelerated approval to Trutakna (formerly known as atacicept) from Vera Therapeutics for adult patients with IgA nephropathy, a chronic kidney disease that can progress to rena…
    BioPharma Dive · 2mo agoApprovalPositive↗ source