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Drug Approval

Everest Medicines' Licensing Partner Pfizer Announces FDA and EMA Acceptance of Etrasimod Regulatory Submissions for Ulcerative Colitis

The European Medicines Agency (EMA) has also accepted the Marketing Authorization Application (MAA) for etrasimod in the same patient population with...

December 22, 2022 | News

Biocytogen Announces FDA Clearance of IND Application for Bispecific Antibody YH008

The trial is an open-label, dose-escalation study (No. YH008101) that will evaluate the safety, tolerability, pharmacokinetics and preliminary anti-tumor a...

December 21, 2022 | News

FDA Approves First Gene Therapy for the Treatment of High-Risk, Non-Muscle-Invasive Bladder Cancer

"This approval provides healthcare professionals with an innovative treatment option for patients with high-risk non-muscle invasive bladder cancer that is...

December 19, 2022 | News

Janssen Submits Biologics License Application to U.S. FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a Biologics License Application (BLA) to the U.S. Food and ...

December 12, 2022 | News

Pfizer and BioNTech Receive U.S. FDA Emergency Use Authorization for Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Vaccine in Children Under 5 Years

Bivalent vaccine authorized as third 3-µg dose in the three-dose primary series Consistent COVID-19 hospitalization rates in this age group couple...

December 08, 2022 | News

FDA grants ODD for new NK treatment

The US FDA has granted Orphan Drug Designation (ODD) for BRM424 in the treatment of neurotrophic keratitis (NK), a rare degenerative eye diseas...

December 08, 2022 | News

Pulmonx Receives Japanese MHLW Approval of Zephyr Endobronchial Valve for the Treatment of Severe COPD/Emphysema

Pulmonx Corporation (Nasdaq: LUNG) (“Pulmonx”), a global leader in minimally invasive treatments for severe lung disease, announced today that ...

December 02, 2022 | News

Everest Medicines Announces Major Regulatory Updates in Taiwan and South Korea

-- Taiwan Food and Drug Administration grants Accelerated Approval Designation (AAD) to Nefecon -- -- Ministry of Food and Drug Safety in S...

November 28, 2022 | News

Hugel's 'Letybo' First in Korea to Obtain Marketing Approval from Australia

Obtained marketing approval on the 23rd (local time) from the Therapeutic Goods Administration (TGA) of Australia for the indication of gl...

November 25, 2022 | News

First Patient Dosed in Phase II 'IPAX-Linz' Study of TLX101 for Glioblastoma Therapy

TLX101 (4-L-[131I] iodo-phenylalanine, or 131I-IPA) is one of Telix's lead therapeutic clinical programs and has been granted orphan drug designation ...

November 22, 2022 | News

Nuance Pharma Announces Clearance of IND Application for Respiratory Syncytial Virus (RSV) Vaccine in China

MVA-BN RSV, is being developed for the prevention of respiratory syncytial virus (RSV) in older adults. The vaccine incorporates five distinct RSV antigens...

November 15, 2022 | News

U.S. FDA Grants EUA for Novavax COVID-19 Vaccine, Adjuvanted as a Booster for Adults

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases,...

October 24, 2022 | News

Chinese NMPA Approves Pivotal Phase III Study of TLX591-CDx for Prostate Cancer Imaging

The IND application was submitted in partnership with Grand Pharmaceutical Group Limited (Grand Pharma), Telix's partner in the Greater China reg...

October 17, 2022 | News

Kira Pharmaceuticals Announces IND Approval from Chinese NMPA

Kira Pharmaceuticals, a global biotechnology company pioneering transformational complement therapies to treat immune-mediated diseases, announced today th...

October 17, 2022 | News

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