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BioPharma Drug Approval

Daewoong Pharmaceutical Gets First Korean US FDA Fast-Track for New Idiopathic Pulmonary Fibrosis Drug

As many Korean pharmaceutical manufacturers are currently attempting to develop new drugs for idiopathic pulmonary fibrosis, Daewoong Pharmaceutical's new ...

July 21, 2022 | News

China CDE Grants Breakthrough Therapy Designation (BTD) to Neurophth's NR082 in LHON

NR082 (rAAV2-ND4), a recombinant adeno-associated viral vector, serotype 2, containing human ND4 codon-optimized gene under the control of the cy...

July 18, 2022 | News

Singapore Based SCG Cell Therapy Announces U.S FDA Clearance

ingapore-based SCG Cell Therapy Pte Ltd ("SCG") announced that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) ...

July 12, 2022 | News

Brii Biosciences Announces Commercial Launch of its Amubarvimab/Romlusevimab Combination Therapy for COVID-19 in China

Brii Bio progressed the combination therapy from discovery to global Phase 3 data readout and first regulatory approval by the China NMPA in les...

July 07, 2022 | News

Australian developed VIRALEZE™ nasal spray relaunched by LloydsPharmacy in the UK

Extensive antiviral testing undertaken at the globally renowned Scripps Research Institute in the United States show that VIRALEZE&trad...

July 01, 2022 | News

GSK's Zejula (niraparib) Tablet approved in Singapore for first-line and recurrent monotherapy maintenance treatment in advanced ovarian cancer

GlaxoSmithKline (GSK) Singapore today announced that Health Sciences Authority has approved Zejula (niraparib) Tablet, an oral, on...

June 29, 2022 | News

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

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