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958 News Found

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


Strides receives USFDA approval for influenza medicine
Drug Approval | January 17, 2022

Strides receives USFDA approval for influenza medicine

The company has 271 cumulative ANDA filings with USFDA of which 243 ANDAs have been approved and 28 are pending approval


Glenmark receives U.S. FDA approval for Ryaltris
Drug Approval | January 14, 2022

Glenmark receives U.S. FDA approval for Ryaltris

The recommended daily dose for Ryaltris is 2 sprays in each nostril twice daily


Pfizer and BioNTech to develop first mRNA-based Shingles vaccine
Biotech | January 07, 2022

Pfizer and BioNTech to develop first mRNA-based Shingles vaccine

Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology. Clinical trials are expected to start in the second half of 2022


Merck KGaA to acquire biopharma CDMO Exelead for $780 million
Biotech | January 07, 2022

Merck KGaA to acquire biopharma CDMO Exelead for $780 million

The transaction is expected to close in the first quarter of 2022


U.S. FDA grants EUA for Pfizer-BioNTech booster for 12 years and older
News | January 03, 2022

U.S. FDA grants EUA for Pfizer-BioNTech booster for 12 years and older

First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age


Novavax submits data to U.S. FDA for Covid-19 EUA
Biotech | January 03, 2022

Novavax submits data to U.S. FDA for Covid-19 EUA

Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance


Siemens Healthineers receive EUA for Covid-19 antigen self-test
Medical Device | December 30, 2021

Siemens Healthineers receive EUA for Covid-19 antigen self-test

Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of Covid-19 exposure