Polpharma Biologics’ Vedolizumab Biosimilar PB016 Accepted for FDA and EMA Review, Advancing Access to Biologic Therapy for Inflammatory Bowel Disease Polpharma Biologics International AG has announced that its proposed vedolizumab biosimilar, PB016, has reached an important regulatory milestone after both…
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,…
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…
Teleflex Receives Historic FDA Approval for EZPLAZ™ Freeze Dried Plasma, Expanding Emergency Blood Transfusion Options Teleflex Incorporated, a global leader in medical technology and innovative healthcare solutions, has announced a landmark achievement with the U.S. Food and Drug Administration (FDA)…
Aqtual Strengthens Executive Leadership with Appointment of Daniil Kalyuzhny as Chief Financial Officer to Support Next Phase of Growth Aqtual, Inc., a precision medicine company pioneering active chromatin cell-free DNA (cfDNA) diagnostics, has announced the appointment of Daniil Kalyuzhny as…
Sarepta Therapeutics Appoints Michael Severino as Chief Executive Officer to Lead Next Phase of Precision Genetic Medicine Growth Sarepta Therapeutics, Inc., a global biotechnology company recognized for its leadership in precision genetic medicine for rare diseases, has announced the appointment…
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…
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…
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,…
Crysvita® Approved Across the EU for Infants Living with X-Linked Hypophosphataemia Kyowa Kirin EMEA, a wholly owned subsidiary of Kyowa Kirin Co., Ltd., has announced that the European Commission (EC) has approved an expanded indication for Crysvita® (burosumab), allowing the…
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…
Clinigen Appoints Greg Skalicky as Group CEO to Lead Next Phase of Global Growth and Patient Access Strategy Clinigen, a global pharmaceutical services company dedicated to improving patient access to critical medicines around the world, has announced the appointment of…