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BioPharma Drug Approval

Lynk Pharmaceuticals Announces Clinical Approval in China for Its Class I New Drug LNK01004

LNK01004 is a novel kinase inhibitor that can simultaneously inhibit multiple inflammatory cytokines and block multiple signaling pathways related to psori...

April 25, 2022 | News

BENDIT Technologies Receives U.S. Food and Drug Administration 510(k) Clearance of its Bendit 021" steerable microcatheter

The clearance was received several months after the successful first use of the Bendit21 neuro catheter in the USA in two life-saving procedures....

April 19, 2022 | News

Seegene's Allplex™ RV Master Assay receives Australian TGA approval, European CE-IVD mark

Test detects 21 targets for 19 respiratory viruses in single tube, including COVID-19 and flu Assay result of Seegene's decades-long know-how, applies D...

April 07, 2022 | News

CanSinoBIO's COVID-19 mRNA Vaccine Receives Approval of Clinical Trial Application in China

Pre-clinical trial results showed that CanSinoBIO's COVID-19 mRNA vaccine can induce high-titer neutralizing antibody levels against multiple SARS-CoV-2 va...

April 05, 2022 | News

Ascletis Announces Completion of First Sale of Its Ritonavir Tablets in China

On April 3, 2022, Ascletis' distributor, Zhejiang Int'l Medicine Co., Ltd. ("Zhejiang Int'l"), completed the first sale of Ascletis' ritonavir tablets...

April 05, 2022 | News

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

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