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Results For "U.S.-FDA"

246 News Found

Jardiance is first and only treatment approved in Europe for chronic heart failure
Drug Approval | March 07, 2022

Jardiance is first and only treatment approved in Europe for chronic heart failure

The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe


Amneal enters U.S. biosimilars market with approval of Releukotm
Drug Approval | March 02, 2022

Amneal enters U.S. biosimilars market with approval of Releukotm

First of three Amneal biosimilars expected for U.S. approval and launch in 2022


US FDA to review Amylyx new drug application for AMX0035
Drug Approval | February 19, 2022

US FDA to review Amylyx new drug application for AMX0035

AMX0035 is an investigational therapy for the treatment of amyotrophic lateral sclerosis (ALS).


Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval
Biotech | February 01, 2022

Moderna’s Covid-19 `Spikevax’ vaccine gets full USFDA approval

Spikevax has received approval by regulators in more than 70 countries, including Canada, Japan, the European Union, the UK, Israel


Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%
Drug Approval | January 28, 2022

Glenmark Pharmaceuticals receives ANDA approval for metronidazole vaginal gel, 0.75%

Glenmark’s current portfolio consists of 173 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA


Glenmark receives ANDA approval for hydrochlorothiazide tablets
Drug Approval | January 27, 2022

Glenmark receives ANDA approval for hydrochlorothiazide tablets

According to IQVIA sales data for the 12-month period ending November 2021, the Ziac tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg, and 10 mg/6.25 mg market achieved annual sales of approximately US $ 30.3 million


Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection
Drug Approval | January 17, 2022

Glenmark Pharmaceuticals receives ANDA tentative approval for Regadenoson injection

The company has 47 ANDA's pending approval with the U.S.FDA


Clarivate identifies seven potential blockbuster drugs in Annual Drugs to Watch report
News | January 10, 2022

Clarivate identifies seven potential blockbuster drugs in Annual Drugs to Watch report

Despite the challenges of pandemic disruptions, drug developers advance promising therapies for conditions, including Alzheimer's, diabetes and asthma


Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis
Biotech | December 24, 2021

Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine