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3152 News Found

Granules Inc., receives ANDA approval for prazosin hydrochloride
Drug Approval | December 28, 2021

Granules Inc., receives ANDA approval for prazosin hydrochloride

The current annual U.S. market for prazosin hydrochloride 1mg, 2mg, 5mg strengths is approximately US $ 54 million, according to IQVIA/IMS Health


Trastuzumab deruxtecan type II variation application validated by EMA
Biotech | December 28, 2021

Trastuzumab deruxtecan type II variation application validated by EMA

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1)


Sun Pharma receives DCGI approval for Molxvir in India
Drug Approval | December 28, 2021

Sun Pharma receives DCGI approval for Molxvir in India

The product is expected to be available in a week’s time


India’s 1st indigenously developed protein sub-unit Covid-19 vaccine Corbevax gets nod
Drug Approval | December 28, 2021

India’s 1st indigenously developed protein sub-unit Covid-19 vaccine Corbevax gets nod

It plans to deliver over 300 million doses to the Indian government


Strides to market molnupiravir under the brand name Stripiravir
Drug Approval | December 28, 2021

Strides to market molnupiravir under the brand name Stripiravir

Molnupiravir is an orally administered form of a potent ribonucleoside analog that inhibits the replication of SARS-CoV-2


Dr Reddy’s receives Emergency Use Authorisation for molnupiravir
Drug Approval | December 28, 2021

Dr Reddy’s receives Emergency Use Authorisation for molnupiravir

The company will market it under the brand name Molflu


Optimus Pharma to manufacture and market molnupiravir
Drug Approval | December 28, 2021

Optimus Pharma to manufacture and market molnupiravir

The company has developed the API in house at its R&D center in Hyderabad


Covaxin receives approval for Emergency Use in Children 12-18 years
Drug Approval | December 27, 2021

Covaxin receives approval for Emergency Use in Children 12-18 years

Covaxin is formulated uniquely such that the same dosage can be administered to adults and children


Lupin receives U.S. FDA approval for Sevelamer Carbonate
Drug Approval | December 27, 2021

Lupin receives U.S. FDA approval for Sevelamer Carbonate

This product will be manufactured at Lupin's Goa facility in India


Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution
Medical Device | December 27, 2021

Roche gets U.S. FDA nod for at-home Covid-19 self-testing solution

The Covid-19 At-Home Test uses a simple nasal swab sample to enable individuals to self-test at home and receive accurate, reliable and quick results in as few as 20 minutes for SARS-CoV-2 and all known variants of concern, including Omicron