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FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease
FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency
Prime Therapeutics Finds Poor Adherence to High-Cost Multiple Sclerosis Therapy
FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar
Ocrevus Significantly Reduces Disease Activity and Disability Progression in Relapsing Multiple Sclerosis

FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

1 day ago FDA News, Vaccines & Immunizations Comments Off on FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE: PFE) today announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy …

FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

1 day ago FDA News, Precision Medicine Comments Off on FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

LONDON & NEW YORK–(BUSINESS WIRE)–MeiraGTx Limited, a vertically integrated, clinical stage gene therapy company, today …

Specialty Pharma Journal Specialty, Precision & Technology

FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

Prime Therapeutics Finds Poor Adherence to High-Cost Multiple Sclerosis Therapy

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

Ocrevus Significantly Reduces Disease Activity and Disability Progression in Relapsing Multiple Sclerosis

Recent Posts

FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

Prime Therapeutics Finds Poor Adherence to High-Cost Multiple Sclerosis Therapy

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

Ocrevus Significantly Reduces Disease Activity and Disability Progression in Relapsing Multiple Sclerosis

Biogen Pays $1 Billion to Expand Partnership with Ionis to Develop Drugs for Various Neurological Diseases

Argos Discontinues Late-Stage Trial of Investigational Vaccine for Patients with Metastatic Renal Cell Carcinoma

Theravance Biopharma’s Trelegy Ellipta Significantly Benefits COPD Patients in Landmark IMPACT Study

GW Pharma Wins Unanimous Recommendation from FDA Committee for Approval of its Cannabis-Based Drug

Personal Genome Diagnostics’ TMB Analysis Shows Promising Checkpoint Inhibitor Efficacy in Early-Stage Lung Cancer Study

FDA Grants Priority Review to the sBLA for Opdivo in Previously Treated Patients with Small Cell Lung Cancer

FDA Approves AstraZeneca’s Tagrisso as First-Line Therapy for EGFR-Mutated Non-Small Cell Lung Cancer

FDA Approves Rigel’s Tavalisse for Chronic Immune Thrombocytopenia in Adult Patients

FDA Approves Crysvita, The First Therapy for X-Linked Hypophosphatemia, A Rare Inherited Form of Rickets

FDA Grants Breakthrough Therapy Designation to Genentech’s Hemlibra for Patients with Hemophilia A Without Inhibitors

FDA Grants Breakthrough Therapy Designation to Pfizer’s Trumenba for Prevention of Invasive Meningococcal B Disease

FDA Grants Fast Track Status to MeiraGTx’s AAV-RPGR for the Treatment of X-Linked Retinitis Pigmentosa Due to RPGR Deficiency

Prime Therapeutics Finds Poor Adherence to High-Cost Multiple Sclerosis Therapy

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