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725 stories matching this filter · ← front page

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  • BioNTech appoints Sobi head Guido Oelkers as new CEO to steer oncology shift
    BioNTech announced that Guido Oelkers, who has led the rare‑disease focused Swedish company Sobi since 2017, will become its next chief executive officer. Oelkers is slated to take over the role b…
    BioPharma Dive · 21d agoNeutral↗ source
  • Supernus and Individor to merge, creating $2 billion brain-drug company
    Supernus and Individor announced a merger that will combine their portfolios of neurological medicines. The two firms together generated about $2 billion in revenue in 2025 from roughly a dozen CN…
    BioPharma Dive · 22d agoDealPositive↗ source
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fda medwatch46
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Psychiatry & CNS743
Ophthalmology451
Pain417
Endocrinology & Metabolism395
Infectious Disease374
  • BlossomHill Therapeutics targets $112 million IPO to fund EGFR lung-cancer drug BH-30643
    BlossomHill Therapeutics, a San Diego oncology biotech, announced plans for an initial public offering to raise about $112 million. The company intends to sell 7.8 million shares at $15-$17 each,…
    Fierce Biotech · 22d agoDealPositive↗ source
  • BD recalls specific lots of intraosseous needle sets over obturator removal issues
    BD announced a voluntary recall of certain lots of its intraosseous vascular access system needle sets after users reported difficulty removing the obturator after placement. The issue is linked t…
    fda medwatch · 22d agoCRLNegative↗ 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 · 22d agoRegulatoryNeutral↗ source
  • Medical Action Industries issues correction for convenience kits with recalled Namic manifolds
    Medical Action Industries has issued a correction notice for certain convenience kits that contain Namic manifolds previously recalled by Medline. The company advises customers to immediately chec…
    fda medwatch · 22d agoCRLNegative↗ source
  • TGA seeks industry input on adopting 11 international scientific guidelines in Australia
    The Therapeutic Goods Administration announced it will consider incorporating eleven internationally recognised scientific guidelines into the Australian regulatory framework. The agency has opene…
    raps · 22d 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 · 22d agoRegulatoryNeutral↗ source
  • Medline orders correction of convenience kits containing lidocaine and bupivacaine in dextrose injection
    Medline has issued a correction for certain convenience kits that include lidocaine hydrochloride and bupivacaine hydrochloride mixed with dextrose injection. The FDA has classified this recall as…
    fda medwatch · 22d agoCRLNegative↗ source
  • American Regent recalls two lots of Adequan canine injection and two lots of Adequan i.m. for horses due to glass fibers
    American Regent Animal Health announced a nationwide recall of specific lots of its Adequan products for dogs and horses. The recall includes two lots of the 100 mg/mL 5 mL multi‑dose canine injec…
    fda medwatch · 22d agoCRLNegative↗ 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 · 22d agoRegulatoryNeutral↗ source
  • Leo International Precision Health AG issues 3.77 million free shares to PC Beteiligungsgesellschaft mbH after capital increase
    Leo International Precision Health AG announced that its shareholder meeting on June 12, 2026 approved a capital increase funded from company reserves. As a result, the company will allocate 3,772…
    globenewswire health · 22d agoNeutral↗ source
  • Leo International Precision Health issues 3.77 million free shares to PC Beteiligungsgesellschaft after capital increase
    Leo International Precision Health AG announced that it will allocate 3,772,368 newly issued free shares to PC Beteiligungsgesellschaft mbH. The allocation follows a capital increase approved by t…
    globenewswire health · 22d agoDealNeutral↗ source
  • After 5-month wait, BioNTech announces Sobi CEO will take on top job at mRNA company
    One of the most closely watched vacancies in biopharma has now been filled, with Sobi CEO Guido Oelkers, Ph.D., moving across to take up the top job at mRNA pioneer BioNTech.
    Fierce Biotech · 22d agoNeutral↗ source
  • Nominations Open for 2026 Fiercest Women in Life Sciences, Deadline Sept 18
    Nominations are now open for the 2026 Fiercest Women in Life Sciences, an annual report that spotlights women making significant contributions across pharma, biotech, medtech, academia, venture cap…
    Fierce Biotech · 22d agoPositive↗ source
  • Leo International Precision Health allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG announced that Mr Leo Wang will receive an allocation of 78,844,000 bonus shares. The shares are issued from the company’s own funds as part of a capital incre…
    globenewswire health · 22d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft
    Leo International Precision Health AG announced that PC Beteiligungsgesellschaft mbH will receive 3,772,368 bonus shares. The allocation stems from a capital increase funded by the company’s own r…
    globenewswire health · 22d agoNeutral↗ source
  • Leo International Precision Health AG grants 78.8 million free shares to board member Leo Wang after capital increase
    Leo International Precision Health AG announced that Mr. Leo Wang, a member of its supervisory board, will receive 78,844,000 free shares. The allocation stems from a capital increase approved by…
    globenewswire health · 22d agoNeutral↗ source
  • Leo International Precision Health AG allocates 78.8 million bonus shares to board member Leo Wang
    Leo International Precision Health AG disclosed that its board member Leo Wang will receive a large allocation of bonus shares. The allocation totals 78,844,000 shares, issued from the company’s o…
    globenewswire health · 22d agoNeutral↗ source
  • Leo International Precision Health allocates 3.77 million bonus shares to PC Beteiligungsgesellschaft following capital increase
    Leo International Precision Health AG announced the allocation of 3,772,368 bonus shares to PC Beteiligungsgesellschaft mbH. The allocation stems from a capital increase funded from the company’s o…
    globenewswire health · 22d agoRegulatoryNeutral↗ source
  • Novo Nordisk's heart drug ziltivekimab fails Phase 3 trial, raising doubts on inflammation-targeted therapies
    Novo Nordisk announced that its experimental cardiovascular drug ziltivekimab did not meet the primary endpoint in a Phase 3 study. The trial was designed to see if the drug could lower the inciden…
    BioPharma Dive · 24d agoNegative readoutNegative↗ source
  • ResMed issues correction for Astral ventilators due to electrical component failure risk
    ResMed has released a correction for certain Astral ventilators after identifying a faulty electrical component that could interrupt therapy and cause serious injury or death. The FDA classifies t…
    fda medwatch · 25d agoRegulatoryNegative↗ source
  • Resilience and Eli Lilly commit $750 million to expand Cincinnati GLP-1 injectable production
    Resilience and Eli Lilly announced a joint $750 million investment to expand drug manufacturing capacity in Cincinnati. The expansion will add at least 400 jobs and increase Resilience's workforce…
    BioPharma Dive · 24d agoDealPositive↗ source
  • Madrigal spends $255 million on multiple MASH drug deals to complement Rezdiffra
    Madrigal Pharmaceuticals is expanding its MASH pipeline by acquiring several assets that could be used alongside its lead candidate, Rezdiffra. In early 2026 the company paid $50 million to Pfizer…
    Fierce Biotech · 25d agoDealPositive↗ source
  • Novo Nordisk's ziltivekimab fails phase 3 trial, jeopardizing CKD program
    Novo Nordisk reported that its phase 3 Zeus trial of the IL‑6 ligand antibody ziltivekimab did not meet its primary endpoint, a setback for the drug's development. The study enrolled more than 6,3…
    Fierce Biotech · 25d agoNegative readoutNegative↗ source