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BioPharma Drug Approval

Vicore announces FDA acceptance of C21 in COVID-19

ATTRACT-3 trial is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVI...

June 14, 2021 | News

FDA Takes Steps to Increase Availability of COVID-19 Vaccine

The agency is announcing today that it is authorizing for use, under the emergency use authorization (EUA) for the Janssen COVID-19 vaccine, two batches of...

June 12, 2021 | News

FDA’s Decision to Approve New Treatment for Alzheimer’s Disease

This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003. Perhaps more significantly...

June 09, 2021 | News | By Dr. Patrizia Cavazzoni, Director, FDA Center for Drug Evaluation and Research

FDA Approval of Aducanumab

Neurimmune welcomes the news that the U.S. Food and Drug Administration (FDA) has approved Biogen's regulatory application for the use of aducanumab in the...

June 08, 2021 | News

Merck’s KEYTRUDA® Given After Surgery Reduced the Risk of Disease Recurrence or Death

First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting Merck’s KEYTRUDA® (pemb...

June 07, 2021 | News

Samsung Pharm & GemVax present pancreatic cancer immunotherapeutic drug, RIAVAX™

ASCO 2021, which celebrates its 57th anniversary this year, runs from June 4th to June 8th and will be held virtually due to COVID-19. Some ...

June 07, 2021 | News

China NMPA Approves MicuRx's Contezolid for Treatment of Drug-Resistant Bacterial Infection

By leveraging the proprietary technology platform built for drug discovery and screening, MicuRx R&D team discovered the next-generation oxazolidinone ...

June 04, 2021 | News

Govt.Of India finalises advance arrangement for Second Made in India Vaccine

Union Ministry of Health finalises advance arrangement with M/s Biological-E Ltd., Hyderabad for 30 cr COVID19 Vaccine doses The COVID-19 vaccine of Biolo...

June 03, 2021 | News

Cognoa Receives FDA Marketing Authorization for Autism Diagnosis Aid

– Cognoa, a pediatric behavioral health company developing diagnostic and therapeutic solutions for children living with behavioral health...

June 03, 2021 | News

Mycovia Pharmaceuticals Submits New Drug Application to the U.S. FDA

Also known as chronic yeast infection, RVVC is a debilitating infectious condition defined as three or more episodes per year. Although RVVC affects nearly...

June 02, 2021 | News

Henlius Received IND Approval for Its Novel Anti-CD73 mAb HLX23 from US FDA

Currently, there is no CD73 targeted product on the market around the globe. A number of early clinical studies have shown reliable safety in monotherapy o...

June 01, 2021 | News

Henlius Received IND Approval for Its Novel Anti-CD73 mAb HLX23 from US FDA

Currently, there is no CD73 targeted product on the market around the globe. A number of early clinical studies have shown reliable safety in monotherapy o...

June 01, 2021 | News

COMIRNATY® is the first to have its CMA extended to adolescents in Europe

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY®...

May 31, 2021 | News

FDA Approves Amgen LUMAKRAS™

KRAS G12C, a Driver Mutation Found in About 13% of Patients With Non-Squamous Non-Small Cell Lung Cancer, is Now Actionable(1) Once-Daily Dosing of LUMAKR...

May 30, 2021 | News

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