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Results For "Food-and-Drug-Administration"

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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


USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine
Biotech | January 04, 2022

USFDA grants ILiAD Biotechnologies Fast Track Designation for pertussis vaccine

BPZE1 is the most advanced next-generation pertussis vaccine currently in clinical development


Emcure to launch oral Covid-19 drug soon
Drug Approval | January 03, 2022

Emcure to launch oral Covid-19 drug soon

A toll-free helpline to be set up to help doctors and patients


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


Ascletis expands ritonavir oral tablet production
Biotech | January 03, 2022

Ascletis expands ritonavir oral tablet production

ASC10 is an oral direct-acting antiviral drug candidate targeting RNA dependent RNA polymerase (RdRp) to treat SARS-CoV-2 infection


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


Quidel’s Antigen tests can detect Omicron variant
Medical Device | December 30, 2021

Quidel’s Antigen tests can detect Omicron variant

The QuickVue antigen tests are able to detect the live Omicron variant with similar performance as with other variants


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


U.S. FDA approves Leo Pharma’s Adbry
Drug Approval | December 29, 2021

U.S. FDA approves Leo Pharma’s Adbry

Adbry is the first biologic launched by LEO Pharma in the United States and is expected to be available in pharmacies by February 2022


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