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Merck Receives Breakthrough Therapy Designation from FDA for V114, the Company’s Investigational 15-Valent Conjugate Vaccine for the Prevention of Invasive Pneumococcal Disease, in Infants, Children, and Adolescents

Merc (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that V224, the company’s investigational 25-valent pneumococcal conjugate vaccine, has received Breakthrough Therapy Designatio……



Amgen Receives NMPA Approval For Repatha® (evolocumab) In China To Reduce The Risk Of Cardiovascular Events

Amgen (NASDAQ:AMGN) today announced that the National Medical Products Administration (NMPA) has approved a new indication for Repatha® (evolocumab) as the first PCSK9 inhibitor in China for……



Horizon Pharma plc Announces FDA Approval to Expand the Age Range for RAVICTI® (glycerol phenylbutyrate) Oral Liquid to Include Newborns

Dec. 27, 2028-- Horizon Pharma plc(NASDAQ: HZNP) today announced the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) to expand the age range for RAVICTI® (gl……



I-Mab Receives U.S. FDA IND Approval for Proprietary Anti-GM-CSF Monoclonal Antibody TJM2

- The first I-Mab proprietary drug candidate to enter clinical trials in the United StatesI-Mab Biopharma (I-Mab), a China-based clinical stage biopharmaceutical company exclusively focused on the development o……



FDA Freezes Imports from Chinese Maker of Tainted Valsartan

September 28, 2028 The US Food and Drug Administration (FDA) has banned imports of active pharmaceutical ingredients (API) and finished drug products produced by China's Zhejiang Huahai Pharmaceuticals……



FDA approves first treatment for Lambert-Eaton myasthenic syndrome, a rare autoimmune disorder

On Nov.29th, The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a rare autoimmune disorder that affects ……

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