Category Regulatory

Meitheal Pharmaceuticals Receives FDA Approval for Garzulys™ Injection

Meitheal Pharmaceuticals Secures FDA Approval for Garzulys™ Biosimilar Insulin to Expand Diabetes Care in the U.S. Meitheal Pharmaceuticals, Inc., a Chicago-based biopharmaceutical company focused on the development and commercialization of generic injectable medicines, biologics, fertility therapies, and branded pharmaceutical products,…

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Cofactor Genomics Appoints Dr. Howard Bailey as Chief Medical Officer

Cofactor Genomics Appoints Renowned Oncologist Dr. Howard H. Bailey as Chief Medical Officer to Advance Precision Immunotherapy Diagnostics Cofactor Genomics, a commercial-stage diagnostics company focused on advancing precision oncology through RNA-based predictive testing, has announced the appointment of internationally recognized…

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Spruce Biosciences Appoints Adrian Quartel as Chief Medical Officer

Spruce Biosciences Strengthens Executive Leadership with Appointment of Rare Disease Expert as Chief Medical Officer Spruce Biosciences, Inc., a late-stage biopharmaceutical company dedicated to developing innovative therapies for neurological disorders with significant unmet medical need, has announced the appointment of…

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Enhanced Welcomes FDA Advisory Panel Vote on Peptide Compounding

Enhanced Group Applauds FDA Advisory Committee Recommendation Supporting Regulated Access to Therapeutic Peptides Enhanced Group Inc. (NYSE: ENHA), a company focused on elite sports performance, personalized health optimization, and evidence-based longevity solutions, has welcomed a significant regulatory development following a…

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Gossamer Bio Reacquires Global Rights to Seralutinib Following FDA Update

Gossamer Bio Advances Toward NDA Submission for Seralutinib, Reacquires Global Rights, and Strengthens Strategic Position Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company dedicated to developing innovative treatments for pulmonary hypertension, has announced a series of significant regulatory, strategic,…

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Pilatus Biosciences Receives Hong Kong CTA Approval for PLT012

Pilatus Biosciences Receives Hong Kong Clinical Trial Authorization for PLT012 and Expands Asia-Pacific Presence with New Regional Subsidiary Pilatus Biosciences, Inc., a clinical-stage biopharmaceutical company focused on developing innovative metabolic checkpoint immunotherapies for liver and gastrointestinal cancers, has announced two…

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Aqtual Appoints Ferhan Qureshi as CTO and Bill Arteca as Head of Biospecimen Strategy

Aqtual Strengthens Executive Leadership to Advance Active Chromatin cfDNA Diagnostics and Precision Medicine Platform Aqtual, Inc., a precision medicine company focused on developing next-generation diagnostics based on active chromatin cell-free DNA (cfDNA), has announced the appointment of Ferhan Qureshi as…

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