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3401 News Found

DCGI approves anti-COVID drug developed by DRDO
Policy | May 10, 2021

DCGI approves anti-COVID drug developed by DRDO

The drug accumulates in the virus infected cells and prevents virus growth by stopping viral synthesis and energy production


Roche receives emergency use authorisation of COVID-19 drug
News | May 07, 2021

Roche receives emergency use authorisation of COVID-19 drug

This Emergency Use Authorisation will now enable Roche to import the globally manufactured product batches to India


Alembic announces USFDA approval for two drugs
News | May 06, 2021

Alembic announces USFDA approval for two drugs

Dorzolamide Hydrochloride and Timolol Maleate Ophthalmic Solution USP, 2% and 0.5% has an estimated market size of US $80 million for twelve months ending December 2020 according to IQVIA


Lonza and Moderna enter new agreement to double drug substance production for COVID-19 vaccine
News | April 30, 2021

Lonza and Moderna enter new agreement to double drug substance production for COVID-19 vaccine

New agreement for three further production lines at Lonza’s site in Visp, Switzerland


COVID-19 drug Remdesivir now priced at Rs. 899
News | March 25, 2021

COVID-19 drug Remdesivir now priced at Rs. 899

Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection.


Government allocates over Rs. 10,000 Cr in PLI scheme for bulk drugs and medical devices: Gowda
News | February 26, 2021

Government allocates over Rs. 10,000 Cr in PLI scheme for bulk drugs and medical devices: Gowda

The Govt. launched the PLI scheme for bulk drugs with a financial outlay of Rs 6,940 crores across 53 APIs over 6 years.


Alembic announces USFDA final approval for Dasatinib Tablets
Drug Approval | November 08, 2025

Alembic announces USFDA final approval for Dasatinib Tablets

The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets


Zydus Lifesciences secures FDA tentative approval for Olaparib tablets
Drug Approval | November 08, 2025

Zydus Lifesciences secures FDA tentative approval for Olaparib tablets

Olaparib is indicated for the treatment of certain types of ovarian, breast, pancreatic, and prostate cancers


Alembic receives FDA final approval for Sumatriptan Injection USP
Drug Approval | November 08, 2025

Alembic receives FDA final approval for Sumatriptan Injection USP

Sumatriptan injection is indicated in adults for the acute treatment of migraine


Lupin Bioresearch Center receives zero observations from USFDA
Drug Approval | November 08, 2025

Lupin Bioresearch Center receives zero observations from USFDA

A bio-analytical Remote Regulatory Assessment was also conducted from October 30 to November 7, 2025, and concluded with no observations