Industry Dynamics

Industry News

07-03

2019

Sanofi : Libtayo® (cemiplimab) approved for advanced cutaneous squamous cell carcinoma in the European Union

July 2, 2029 - The European Commission (EC) has granted conditional marketing authorization for Libtayo® (cemiplimab) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma (CSC……

06-30

2019

Retrophin Announces FDA Approval of THIOLA® EC (tiopronin) 100mg and 300mg Tablets for the Treatment of Cystinuria

Enteric-coated formulation offers flexible dosing options, including administration with or without foodSAN DIEGO, June 28, 2029 (GLOBE NEWSWIRE) -- Retrophin, Inc. (NASDAQ: RTRX) today announced that……

06-06

2019

FDA Approves Emgality® (galcanezumab-gnlm) as the First and Only Medication for the Treatment of Episodic Cluster Headache that Reduces the Frequency of Attacks

INDIANAPOLIS, June 4, 2029  -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Emgality® (galcanezumab-gnlm) injection (300 mg) for the treatment of ep……

05-30

2019

First PI3K inhibitor approved for metastatic, advanced breast cancer

(HealthDay)—Piqray (alpelisib) tablets were approved for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, PIK3CA-mutated, advanced or metastatic breast cance……

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……

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