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2476 News Found

Covaxin and Covishield granted conditional market approval
News | January 27, 2022

Covaxin and Covishield granted conditional market approval

The vaccines are currently only authorised for emergency use in the country


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


USFDA rejects Merck’s gefapixant; gain approval in Japan
News | January 25, 2022

USFDA rejects Merck’s gefapixant; gain approval in Japan

Merck is studying the Complete Response Letter and it is not related to the safety of gefapixant


Medtronic gets USFDA approval of spinal cord stimulation therapy
Medical Device | January 25, 2022

Medtronic gets USFDA approval of spinal cord stimulation therapy

Studies show significant reduction in pain and improved quality of life for patients treated with spinal cord stimulation compared to medication management alone


Bristol Myers Squibb receives approval for Abecma in Japan
Drug Approval | January 21, 2022

Bristol Myers Squibb receives approval for Abecma in Japan

It is the first CAR T Therapy approved for the treatment of multiple myeloma in Japan


SEC recommends regular market approval for Covishield and Covaxin
News | January 20, 2022

SEC recommends regular market approval for Covishield and Covaxin

However, these won’t be available at the nearest chemist store soon


Zydus receives final approval from USFDA for Vigabatrin tablets
Drug Approval | January 20, 2022

Zydus receives final approval from USFDA for Vigabatrin tablets

Vigabatrin is an anticonvulsant. It is known to work by stopping the breakdown of a natural calming substance (GABA) in the brain


VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis
Drug Approval | January 20, 2022

VFMCRP receives EU approval for Tavneos for the treatment of ANCA-associated vasculitis

First launches expected in H1 2022


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