Latest news and insights on the pharmaceutical industry | Indian Pharma Post | Page 63

Results For "USFDA"

1135 News Found

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy
Drug Approval | January 26, 2022

Roche’s Evrysdi granted USFDA priority review for treatment of spinal muscular atrophy

Evrysdi is approved in 70 countries and submitted in a further 31 with more than 4,500 patients treated to date


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


Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation
News | January 25, 2022

Control Print’s 3-ply surgical masks receive USFDA 510(K) authorisation

The company has been manufacturing masks since the Covid-19 outbreak in 2020


USFDA approves IND application for Allied’s cancer treatment
Biotech | January 24, 2022

USFDA approves IND application for Allied’s cancer treatment

APS03118 is a novel innovative drug developed by APS with global independent intellectual property rights for unlimited cancer types


USFDA expands use of Remdesivir  for Covid-19
News | January 22, 2022

USFDA expands use of Remdesivir for Covid-19

Previously, the use of the drug was limited to patients requiring hospitalization


Lannett receives USFDA safety review for biosimilar insulin glargine
Biotech | January 22, 2022

Lannett receives USFDA safety review for biosimilar insulin glargine

Go-ahead for pivotal clinical trial which is expected to commence by March


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


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


Jubiant Therapeutics gets USFDA clearance for JBI-802 to treat solid tumours
Biotech | January 07, 2022

Jubiant Therapeutics gets USFDA clearance for JBI-802 to treat solid tumours

JBI-802 is a novel, oral, potent and selective dual inhibitor of two epigenetic targets of the CoREST complex: LSD1 and HDAC6