BioPharma Drug Approval

Menarini and SciClone to Develop and Commercialize Vaborem® in China to Treat Antimicrobial Resistant Infections

Vaborem®, a patented combination of meropenem and vaborbactam, is expected to address the rising prevalence of carbapenem-resistant Klebsiella pneumo...

 September 21, 2022 | News

WuXi Biologics' Drug Substance and Drug Product Facilities Again Approved by U.S. FDA and EMA

After passing online Pre-Approval Inspection (PAI), WuXi Biologics received EMA GMP certificates for the commercial manufacturing of two biologics develope...

 September 20, 2022 | News

KOAG Receives FDA Clearance for Vascette® HP Hemostatic Pad for Vascular Closure

Vascette® is a unique, topical closure pad incorporating a proprietary, plant-derived hemostatic foam. The Vascette® patent-pending technology supp...

 August 25, 2022 | News

Nuance Pharma Announces Clearance of IND Application for Ensifentrine Pivotal Clinical Trials for COPD in China

Ensifentrine is a first-in-class, dual inhibitor of the enzymes phosphodiesterase 3 and 4 ("PDE3" and "PDE4") combining bronchodilator and anti-inflam...

 August 21, 2022 | News

FDA Approves First Cell-Based Gene Therapy to Treat Adult and Pediatric Patients

"This approval is an important advance in the treatment of beta-thalassemia, particularly in individuals who require ongoing red blood cell transfusions," ...

 August 18, 2022 | News

Bridge Biotherapeutics Receives FDA Authorization to Proceed with Phase 2 Study of BBT-877

Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company developing novel drugs for cancer, fibrosis and inflammation, announ...

 August 17, 2022 | News

Taiwan FDA accepts New Drug Application for Xerava for treatment of cIAI

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

 August 11, 2022 | News

MedAlliance SELUTION SLR Receives Second FDA IDE Approval

This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications (May 2022). Enr...

 August 10, 2022 | News

Lynk Pharmaceuticals Announces IND Approval of LNK01004 for Atopic Dermatitis in China

LNK01004 is a novel kinase inhibitor that can simultaneously inhibit multiple cytokine-induced signaling pathways in vitro and in vivo. LNK01004 is tissue-...

 August 04, 2022 | News

Armata Pharmaceuticals Announces Clearance of IND for Prosthetic Joint Infections

Second indication for AP-SA02 which targets Staphylococcus aureus including MRSA Potential to significantly improve PJI patient outcomes Expands Armata...

 August 03, 2022 | News

Polpharma Biologics Announces FDA File Acceptance for Review of Natalizumab, First Proposed Biosimilar to Tysabri®

The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as the reference medicine, Ty...

 July 26, 2022 | News

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

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