BioPharma Drug Approval

US FDA Clears IND for Cynata's Phase 2 Clinical Trial of CYP-001 in GvHD

Key Highlights: US FDA has cleared Cynata's IND application for a Phase 2 clinical trial of CYP-001 in patients with aGvHD – a major mil...

 May 27, 2022 | News

FDA Approves First Treatment for Eosinophilic Esophagitis, a Chronic Immune Disorder

"As researchers and clinicians have gained knowledge about eosinophilic esophagitis in recent years, more cases of the disorder have been recognized and di...

 May 23, 2022 | News

BD and Mitsubishi Gas Chemical Have Signed a Letter Of Intent (LOI) to Discuss a Partnership Agreement to Explore New Ways to Advance Biologic Drug Delivery

 BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, and Mitsubishi Gas Chemical Company, Inc. ...

 May 18, 2022 | News

New therapeutic option to reduce risk of cardiovascular deaths and repeated hospitalizations among adult heart failure patients approved in Singapore

Over the course of the VICTORIA study, there was a 4.2% reduction in annualized absolute risk with VERQUVO™ (vericiguat) compared with pl...

 May 18, 2022 | News

GQ1005 and GQ1007, Have Been Approved for Clinical Trials in Australia

 GeneQuantum Healthcare (Suzhou) Co., Ltd. (hereinafter referred to as "GeneQuantum"), a global innovative biotechnology company dedicated to the deve...

 May 16, 2022 | News

Inmagene Receives FDA's IND Clearance for OX40 Antagonist

IMG-007 is highly potent at blocking the binding of OX40 to OX40L, thereby reducing OX40L-dependent downstream signaling and cytokine release by T cells. I...

 May 03, 2022 | News

Inmagene Receives FDA's IND Clearance for OX40 Antagonist

IMG-007 is highly potent at blocking the binding of OX40 to OX40L, thereby reducing OX40L-dependent downstream signaling and cytokine release by T cells. I...

 May 02, 2022 | News

FDA Approves Direct Biologics to Proceed with a Landmark Phase 3 Acute Respiratory Distress Syndrome (ARDS) Trial

The Phase 3 trial will be conducted under the auspices of the first Regenerative Medicine Advanced Therapy (RMAT) designation approved by the FDA for an EV...

 April 28, 2022 | News

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


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