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Results For "authorization"

309 News Found

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


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


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


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


U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir
News | December 24, 2021

U.S. FDA issues Emergency Use Authorisation for Merck’s molnupiravir

The authorization provides an additional treatment option against the Covid-19 virus in the form of a pill that can be taken orally


Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis
Biotech | December 24, 2021

Biocon partner Equillium initiates clinical study for Itolizumab in Lupus Nephritis

Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000


Pfizer’s Covid-19 pill gets U.S. FDA clearance
Drug Approval | December 23, 2021

Pfizer’s Covid-19 pill gets U.S. FDA clearance

Pfizer raises production projections from 80 million to 120 million courses of treatment in 2022, as a result of continued investments to support the manufacturing and distribution of Paxlovid


WHO grants EUL for Covovax
Drug Approval | December 20, 2021

WHO grants EUL for Covovax

First Emergency Use Listing granted by WHO for a protein-based Covid-19 vaccine


Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant
News | December 17, 2021

Astra Zeneca’s antibody combination to prevent Covid-19 neutralises Omicron variant

The study was performed independently by investigators at the US Food and Drug Administration (FDA), Center for Biologics Evaluation and Research


EMA approves Pfizer’s Covid-19 anti-viral candidate
News | December 17, 2021

EMA approves Pfizer’s Covid-19 anti-viral candidate

EMA’s CHMP advice states that Paxlovid can be used for treatment of adults with Covid-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe disease