BioPharma Drug Approval

Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant

Intended for potential treatment of ER+/HER2- advanced or metastatic breast cancer patients Priority Review requested; if accepted, anticipate an 8-mont...

 June 23, 2022 | News

FDA Recommends EUA of Novavax COVID-19 Vaccine for People Aged 18 Years and Older

If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the...

 June 09, 2022 | News

Harbour BioMed Announces IND Approval for B7H4x4-1BB Bispecific Antibody

This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of HBM7008 in patients with soli...

 June 09, 2022 | News

Made-In-Singapore Cancer Drug ETC-159 Advances In Clinical Trials

A made-in-Singapore cancer drug, ETC-159, has advanced into the dose expansion  portion of its Phase 1B clinical trial. The Phase 1B dose expansion st...

 June 06, 2022 | News

Merck Advances Development Programs in Oncology Focusing on Novel Mechanisms and Pathways

New data from DNA Damage Response (DDR) inhibitor portfolio inform development path for this promising biology Clinical trials in locally advanced head ...

 June 06, 2022 | News

Cambrex Acquires Leading EU Stability Storage Company Q1 Scientific

"Stability storage and testing is a critical component of drug development and commercialization of new therapies. Q1 Scientific brings world-class capabil...

 June 02, 2022 | News

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


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