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374 stories matching this filter · ← front page

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  • 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 · 17d agoRegulatoryNeutral↗ 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 · 17d agoRegulatoryNeutral↗ source
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  • 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d 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 · 17d agoRegulatoryNeutral↗ 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 · 20d 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 · 20d agoNegative readoutNegative↗ source
  • Apnimed upsizes IPO to $192 million to fund launch of oral sleep‑apnea drug
    Apnimed, a Massachusetts‑based biotech, announced an upsized initial public offering that now includes 12 million shares priced at $16 each, generating $192 million in gross proceeds. This amount e…
    Fierce Biotech · 20d agoDealPositive↗ source
  • FDA announces reorganization and CTAGTAC votes on Duchenne muscular dystrophy and melanoma therapies
    The FDA disclosed a major internal reorganization aimed at streamlining its operations and improving efficiency across its divisions. The agency’s Cellular, Tissue, and Gene Therapies Advisory Com…
    raps · 20d agoRegulatoryNeutral↗ source
  • FDA releases draft guidance on container closure and device components for biosimilar combination products
    The FDA issued draft guidance aimed at helping sponsors develop container closure systems and device constituents for biosimilar and interchangeable biosimilar combination products. The guidance f…
    raps · 20d agoRegulatoryNeutral↗ source
  • Bristol Myers pushes Cobenfy Alzheimer’s psychosis readout to early 2027 after enrollment delays
    Bristol Myers Squibb said the Phase 3 readout for its Cobenfy Alzheimer’s psychosis program will be postponed to early 2027. The company had previously expected data from the three Adept trials to…
    Fierce Biotech · 21d agoNegative readoutNegative↗ source
  • J&J invests $785M in Sail Biomedicines, secures option to buy for $2.58B
    Johnson & Johnson has agreed to pay $785 million up front to Sail Biomedicines, including a $465 million equity infusion and up to $140 million in milestone payments. The agreement also gives J&J a…
    Fierce Biotech · 21d agoDealPositive↗ source
  • Replimune's melanoma virus therapy wins FDA advisory committee vote after two rejections
    Replimune's oncolytic virus RP1, also called vusolimogene oderparepvec and Tudriqev, has been rejected twice by the FDA. Today an advisory committee voted 10 to 3 that the candidate shows enough ef…
    Fierce Biotech · 20d agoRegulatoryPositive↗ source
  • BMS CEO says firm not pressured to pursue acquisitions despite quiet M&A year
    BMS chief executive Chris Boerner told analysts on the second‑quarter earnings call that the company’s robust late‑stage pipeline means it does not feel any compulsion to chase deals. The firm has…
    Fierce Biotech · 21d agoDealNeutral↗ source
  • Labcorp reports Q2 sales of $3.73 billion, lifts full-year revenue outlook despite missing consensus
    Labcorp announced second‑quarter revenue of $3.73 billion, up from $3.53 billion a year earlier, driven by strong performance across its core businesses. The Diagnostics division grew 5.5% to $2.9…
    Fierce Biotech · 21d agoEarningsNeutral↗ source
  • Takeda drops its second celiac disease candidate, TAK-101, after unimpressive phase 2 results
    Takeda said it is halting development of TAK-101, its second candidate for celiac disease, after a phase 2 study failed to meet expectations. TAK-101 is a nanoparticle that carries gliadin, a glut…
    Fierce Biotech · 21d agoNegative readoutNegative↗ source
  • GSK signs up to $110 million AI data partnership with Relation
    GSK announced a research collaboration with AI-focused biotech Relation, valued at up to $110 million. Under the agreement Relation will produce large-scale datasets that capture how human cells r…
    Fierce Biotech · 21d agoDealPositive↗ source