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354 stories matching this filter · ← front page

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  • 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 · 11d 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 · 11d agoNeutral↗ source
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  • 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 · 11d 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 · 11d 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 · 11d agoRegulatoryNeutral↗ 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 · 14d agoRegulatoryNegative↗ source
  • Abiomed recalls 14Fr Low Profile Introducer Kits over thrombus risk
    The FDA has issued an early alert about a recall of Abiomed 14Fr Low Profile Introducer kits, which are used with Impella CP devices. The recall follows a higher‑than‑expected rate of complaints i…
    fda medwatch · 14d agoCRLNegative↗ 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 · 14d 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 · 14d agoRegulatoryNeutral↗ source
  • Argon Medical issues correction for convenience kits containing lidocaine ampules after FDA safety alert
    Argon Medical has sent a correction notice to customers about certain convenience kits that include lidocaine HCl ampules supplied by Spectra Medical Devices. The FDA has classified this correctio…
    fda medwatch · 15d agoCRLNegative↗ source
  • FDA releases FY 2027 user fee rates for prescription, generic, biosimilar, device and over the counter programs
    The U.S. Food and Drug Administration has published its user fee schedule for fiscal year 2027. The rates cover prescription drugs, generic drugs, biosimilars, medical devices and over the counter…
    raps · 15d agoRegulatoryNeutral↗ source
  • FDA releases updated guidances for injectable peptide drugs and announces FY 2027 user fee rates
    The FDA has updated 17 draft product-specific guidances aimed at helping sponsors prepare abbreviated new drug applications for injectable peptide products. The guidances cover peptide therapies u…
    raps · 15d agoRegulatoryNeutral↗ source
  • Study Finds Accelerated Approval Rarely Used for Adult Cancer Drugs Over Past 20 Years
    A new analysis published in JAMA shows that most adult oncology medicines approved by the FDA in the last two decades received standard approvals for expanded uses, relying on surrogate endpoints r…
    raps · 15d agoNegative↗ source
  • FDA releases FY 2027 user fee rates and updates guidance for injectable peptide ANDAs
    The U.S. Food and Drug Administration has published its user fee rates for fiscal year 2027, covering prescription drugs, generics, biosimilars, medical devices and over‑the‑counter products. The r…
    raps · 15d agoRegulatoryNeutral↗ source
  • EFPIA urges EU lawmakers to further cut clinical trial approval timelines under Biotech Act
    The European Federation of Pharmaceutical Industries and Associations (EFPIA) has asked EU legislators to go beyond the modest reductions in clinical trial approval times that are currently being c…
    raps · 15d agoRegulatoryNeutral↗ source
  • Leo International Precision Health AG board member Leo Wang buys shares worth €55,933
    Leo International Precision Health AG announced that board member Leo Wang has purchased shares of the company. The transaction involved shares with ISIN DE0005490601 and was executed on July 27, 2…
    globenewswire health · 14d agoDealNeutral↗ source
  • Leo International Precision Health AG discloses insider share acquisition by board member Leo Wang
    Leo International Precision Health AG announced that Leo Wang, a member of its administrative or supervisory body, has purchased shares of the company. The transaction involved a total considerati…
    globenewswire health · 14d agoDealNeutral↗ source
  • FDA approves first freeze-dried plasma product for U.S. use
    The FDA has licensed Ezplaz Freeze Dried Plasma (FDP), marking the first freeze-dried plasma product cleared for use in the United States. The product is intended for adult patients who need plasm…
    fda press · 15d agoApprovalPositive↗ source
  • Nokia reports senior executive Kristen Pressner purchases 66,324 shares at €7.84 each
    Nokia Oyj filed a market abuse regulation disclosure on July 29, 2026 indicating that senior executive Kristen Pressner bought shares of the company. The transaction involved 66,324 ordinary share…
    globenewswire health · 15d agoDealNeutral↗ source
  • Vesa Pylvänäinen sells 117 Vaisala shares at €57 each
    Vaisala Corporation reported a share disposal by one of its senior managers, Vesa Pylvänäinen. On July 24, 2026, Pylvänäinen sold 117 of the company’s A‑shares at a price of €57 per share, resulti…
    globenewswire health · 15d agoRegulatoryNeutral↗ source
  • Nokia senior manager Mikko Hautala buys 7,103 shares at €7.84 each
    Nokia reported an insider transaction filed under market abuse regulation article 19. The filing lists Mikko Hautala, identified as "Other senior management", as the reporting person. On July 29,…
    globenewswire health · 15d agoCRLNeutral↗ source
  • Vaisala senior executive Vesa Pylvänäinen sells 117 shares at €57 each on Nasdaq Helsinki
    Vaisala Oyj announced that senior executive Vesa Pylvänäinen has disposed of company shares. The transaction was executed on July 24, 2026 and involved 117 ordinary shares at an average price of €…
    globenewswire health · 15d agoNeutral↗ source
  • Nokia senior manager Kristen Pressner purchases 66,324 shares at €7.84 each
    On July 29, 2026, Nokia Corporation disclosed that senior manager Kristen Pressner acquired shares of the company. The transaction involved 66,324 Nokia shares purchased at an average price of €7.…
    globenewswire health · 15d agoNeutral↗ source
  • Nokia senior manager Mikko Hautala buys 7,103 shares at €7.84 each
    Nokia Corporation disclosed that senior manager Mikko Hautala purchased 7,103 shares of the company on July 29, 2026. The transaction was reported under Article 19 of the EU Market Abuse Regulation…
    globenewswire health · 15d agoRegulatoryNeutral↗ source
  • Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selection
    Industry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…
    raps · 17d agoRegulatoryNeutral↗ source