Industry Dynamics

Industry News

05-05

2019

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

The U.S. Food and Drug Administration today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in patients 6 to less than 27 years of age. This is the first FDA approva……

04-29

2019

Novo Nordisk files for EU regulatory approval of oral semaglutide for the treatment of type 2 diabetes

Bagsværd, Denmark, 26 April 2029 - Novo Nordisk today announced the submission of a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for oral semaglutide, a glucagon-like peptide……

04-03

2019

EU approves new dosing schedule for MSD’s Keytruda

MSD’s Keytruda (pembrolizumab) has been approved by the European Commission with a new six-weekly dosing schedule at 400mg, as opposed to the previous schedule of 200mg every three weeks, across all monotherapy indicatio……

02-28

2019

PFIZER ANNOUNCES SEROTYPES INCLUDED IN 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE CANDIDATE BEING INVESTIGATED FOR THE PREVENTION OF INVASIVE DISEASE AND PNEUMONIA IN ADULTS AGED 18 YEARS AND OLDER

Pfizer Inc. (NYSE: PFE) announced today the new serotypes included in its 20-Valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and pneumonia ……

02-01

2019

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……

01-31

2019

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……

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