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FDA

  • Biotech & Pharma Business,Clinical & Regulatory,Pharmaceuticals and therapeutics

    FDA approves Meitheal’s rapid-acting insulin biosimilar Garzulys

    The US Food and Drug Administration (FDA) has approved Meitheal [...]

    July 31, 2026
  • Biotech & Pharma Business,Digital & Data,Drug Delivery & Formulation,Pharmaceuticals and therapeutics

    PolyPid’s D-PLEX100 receives FDA Priority Review for surgical site infection prevention

    PolyPid’s D-PLEX100 has been granted FDA Priority Review following acceptance [...]

    July 29, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Research & Development

    HAYA Therapeutics wins FDA Fast Track designation for HTX-001 in heart disease

    HAYA Therapeutics has received FDA Fast Track designation for HTX-001, [...]

    July 29, 2026
  • Clinical & Regulatory,Drug Delivery & Formulation,Pharmaceuticals and therapeutics,Research & Development

    FDA allows Medicus Pharma to start SkinJect study in patients with Gorlin Syndrome

    Medicus Pharma has received FDA clearance to begin a Phase [...]

    July 28, 2026
  • Advanced Therapies,Clinical & Regulatory,Genomics and sequencing,Pharmaceuticals and therapeutics,Research & Development

    Atsena receives EMA orphan designation for two inherited retinal disease gene therapies

    Atsena Therapeutics has received EMA orphan designation for two gene [...]

    July 24, 2026
  • Clinical & Regulatory,Pharmaceuticals and therapeutics,Research & Development

    Medicus receives FDA feedback and IRB approval for Teverelix Phase 2 urinary retention trial

    Medicus Pharma has received positive feedback from FDA and central [...]

    July 20, 2026
  • Biotech & Pharma Business,Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics

    Adneuris licenses Phase 3 pain therapy cebranopadol to Conba for Greater China

    Adneuris Therapeutics has granted Zhejiang Conba Pharmaceutical exclusive rights to [...]

    July 15, 2026
  • Clinical & Regulatory,Medical devices,Pharmaceuticals and therapeutics,Research & Development

    Revita maintains GLP-1 weight loss one year after treatment discontinuation in REMAIN-1 trial

    Fractyl Health has reported positive one-year data from the midpoint [...]

    July 16, 2026
  • Clinical & Regulatory,Drug Discovery & Development,Pharmaceuticals and therapeutics,Therapeutic Areas

    FDA grants Fast Track status to SOTIO’s colorectal cancer ADC ahead of Phase 1/2 trial

    The US FDA has granted Fast Track Designation to SOTIO [...]

    July 14, 2026
  • Clinical & Regulatory,Medical devices,Pharmaceuticals and therapeutics,Therapeutic Areas

    Theranica expands Nerivio migraine device coverage to more than half of insured Americans

    Theranica’s Nerivio wearable migraine therapy is now covered by health [...]

    July 13, 2026
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