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Drug Approval

Yuyu Pharma Signs Exclusive Distribution Agreement with Novartis Korea

Yuyu Pharma, a pharmaceutical company based in Korea, and Novartis Korea announced today that the companies have entered into an agreement in which Yuyu wi...

August 04, 2021 | News

Vietnam to establish a manufacturing facility for Arcturus’ mRNA Covid-19 vaccine

Arcturus Therapeutics is a leading clinical stage company focused on messenger RNA (mRNA) medicines - one of the most advanced medicinal technologies in th...

August 03, 2021 | News

FDA Approves First Interchangeable Biosimilar Insulin Product for Treatment of Diabetes

Today, the U.S. Food and Drug Administration approved the first interchangeable biosimilar insulin product, indicated to improve glycemic control in adults...

July 29, 2021 | News

DCGI has approved biotechnology Panacea Biotech to manufacture Sputnik V in India.

The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India. The batches produced at Panacea Biotec’s faciliti...

July 05, 2021 | News

BioGX Receives FDA EUA Approvals

BioGX, a global provider of molecular diagnostic solutions, announced that the United States Food and Drug Administration has issued Emergency Use Authoriz...

July 05, 2021 | News

Lupin Announces FDA Approval for SOLOSEC® to Combat STD's

SOLOSEC® demonstrated a 92.2% clinically and statistically significant cure rate for patients with trichomoniasis based on a landmark Phase 3 clinical ...

July 04, 2021 | News

Innovent Biologics Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market

Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medi...

June 22, 2021 | News

Chinese Bioheng Biotech received ODD from the U.S. FDA

"CTD401 is the first innovative product based on our next-generation generic CAR-T technology platform. It has excellent efficacy and superior safety in ex...

June 21, 2021 | News

With Serum Institute as a partner, Novavax is poised to launch in India.

The Novavax trials conducted on 29,960 people in the US and Mexico have delivered results that equal the Pfizer NSE -1.09 % and Moderna jabs and do better ...

June 16, 2021 | News

FDA Approves StrataGraft for the Treatment of Adults with Thermal Burns

Thermal burns are typically caused by direct contact with an external heat source such as steam, scalding water, hot surfaces or fire. "Serious burns can ...

June 16, 2021 | News

Harbour BioMed and Dana-Farber to Advance Novel Biotherapies for Cancer Treatment

Harbour BioMed scientists and Dana-Farber researchers will be working together to develop novel oncologic drugs, including bispecific antibodies and CAR-T ...

June 16, 2021 | News

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

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