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Drug Approval

Ascletis Announces Submission of Marketing Authorization Application for Ritonavir in Hong Kong

Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9) released on March 15, 2022 by the National Health Commiss...

April 04, 2022 | News

FDA approves CartiHeal's Implant for the Treatment of Cartilage and Osteochondral Defects

CartiHeal Ltd, developer of implants for the treatment of cartilage and osteochondral defects in arthritic and non-arthritic knee-joints, today annou...

March 31, 2022 | News

Daewoong Pharmaceutical submitted NDA for its global new drug Fexuclue Tablets to the Philippines

Daewoong Pharmaceutical (CEO Sengho Jeon & Changjae Lee) recently announced that it has submitted the New Drug Application (NDA) for a n...

March 29, 2022 | News

NeuroSense Therapeutics Receives FDA Clearance of IND for PrimeC for the Treatment of ALS

NeuroSense Therapeutics Ltd. (Nasdaq: NRSN) ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced tha...

March 22, 2022 | News

China CDE Approved First Universal CAR-T IND !

"The approval of CTA101 product IND is an important milestone for Bioheng in developing innovative immuno-cell therapies", said Xiaohong He, CEO of Bi...

March 18, 2022 | News

Lynk Pharmaceuticals and Simcere announced Strategic Commercialization Partnership

Under the terms of the agreement, Lynk Pharmaceuticals is responsible for the development of the product. Simcere will obtain the exclusive rights to marke...

March 18, 2022 | News

Antengene Announces HREC Approval in Australia

ATG-037 is the first orally-available, small molecule CD73 inhibitor to advance to clinical-stage by a Chinese company - The Phase I study will evaluate A...

February 07, 2022 | News

Singapore (HSA) approval marks the first in a series of expected approvals of Trodelvy in Asia

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative ph...

February 07, 2022 | News

Novavax Submits Request to the U.S. FDA for EUA of COVID-19 Vaccine

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases,...

February 01, 2022 | News

BeiGene Announces Acceptance of Supplemental New Drug Application in China

BRUKINSA was granted its first breakthrough therapy designation in China with this application The application is supported by SEQUOIA trial results, whic...

January 31, 2022 | News

The Philippines Has Approved ReCOV For Phase II/III Clinical Trial

Recombinant Two-Component COVID-19 Vaccine (ReCOV) was approved for International Phase II/III Clinical Trial ReCOV induced high levels of neutralizing ...

January 18, 2022 | News

Jacobio Receives IND Approval for Aurora A Inhibitor JAB-2485 from FDA

JAB-2485 is a highly selective small molecule Aurora A inhibitor. JAB-2485 can inhibit Aurora A activity at the cellular level, induce apoptosis and inhibi...

January 17, 2022 | News

CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

With the RMAT designation, CT041 enjoys all the benefits of Fast Track and Breakthrough Therapy designations including early and intensive FDA guidance on ...

January 11, 2022 | News

CanSinoBIO Announces Approval for its MCV4 Product Menhycia™ in China

Leveraging CanSinoBIO's industry-leading synthetic biotechnology and formulation technology platform, Menhycia™ covalently binds common pathogen...

January 10, 2022 | News

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