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
Emergency Use Authorisation application request to be submitted following one month required by FDA EUA guidance
First emergency use authorization in the United States for a Covid-19 vaccine booster in adolescents 12 through 15 years of age
Rapid antigen testing provides results in just 15 minutes and the information can help reduce the risk of Covid-19 exposure
It will be marketed under the brand name Molunamax
The Subject Expert Committee (SEC), on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Monday recommended granting permission to manufacture and market anti-Covid pill molnupiravir for restricted emergency use
Flattish volume growth and subdued new launches were key factors for last month
Only antibody authorised in the US for pre-exposure prophylaxis of COVID-19
Acquisition provides opportunity to develop cladribine in generalized Myasthenia Gravis (gMG) and Neuromyelitis Optica Spectrum Disorder (NMOSD)
Acquisition will add GT005 to the Novartis portfolio, an investigational, one-time gene therapy currently in Phase 2 for the treatment of people living with Geographic atrophy
The medicine is the first and only oral MET inhibitor to receive CHMP positive opinion in Europe for adult patients with advanced NSCLC harbouring alterations leading to METex14 skipping
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