Drug Approval
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
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
Most Read
- 2025 Pharma and Medical Device Trends for Manufacturing Leaders
- 25 High-Value Drugs Losing Patent Protection in 2025: What It Means for Healthcare
- BioPharma Trends 2025: 25 Key Insights Shaping Asia Pacific's Future
- Driving Oncology Forward: 25 Companies Redefining Antibody-Drug Conjugates (ADCs) in 2025
- 25 Biopharma Leaders Shaping a Sustainable 2025: Innovation Meets Environmental Responsibility
- 25 Leading AI Companies to Watch in 2025: Transforming Drug Discovery and Precision Medicine
- Mr. Brendan O’Callaghan Discusses Sanofi’s Singapore Modulus Facility: Advancing Biopharma Manufacturing and Pandemic Preparedness
- Shaping the Future of PCV Care: Insights from Roche’s Stefan Scheidl on the SALWEEN Trial
- Pam Cheng Outlines AstraZeneca’s Bold Vision for Singapore’s First End-to-End ADC Manufacturing Facility
- Shaping a Health Innovation Hub: Alessandro Falcone Reflects on JLABS Singapore’s Milestone Year and Future Goals
Bio Jobs
- Top Management Shakeups of 2024: Redefining Pharma, Biopharma, and Biotech Leadership
- James Park Joins South Korean LOTTE BIOLOGICS as New CEO to Lead Global Expansion
- Australia Takes the Lead: Moderna Opens Southern Hemisphere’s First mRNA Manufacturing Facility in Victoria
- Eli Lilly Announces $3 Billion Expansion in Wisconsin to Boost Global Medicine Production
- Ngee Ann Polytechnic Partners with Merck Singapore to Elevate Biopharmaceutical Education
- Pam Cheng Outlines AstraZeneca’s Bold Vision for Singapore’s First End-to-End ADC Manufacturing Facility
- Life Sciences CEOs Bet Big on AI and Workforce Growth Despite Economic and Industry Headwinds
News
