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BioPharma Drug Approval

BeiGene Announces Acceptance of Supplemental New Drug Application in China

BRUKINSA was granted its first breakthrough therapy designation in China with this application The application is supported by SEQUOIA trial results, whic...

January 31, 2022 | News

The Philippines Has Approved ReCOV For Phase II/III Clinical Trial

Recombinant Two-Component COVID-19 Vaccine (ReCOV) was approved for International Phase II/III Clinical Trial ReCOV induced high levels of neutralizing ...

January 18, 2022 | News

Jacobio Receives IND Approval for Aurora A Inhibitor JAB-2485 from FDA

JAB-2485 is a highly selective small molecule Aurora A inhibitor. JAB-2485 can inhibit Aurora A activity at the cellular level, induce apoptosis and inhibi...

January 17, 2022 | News

CARsgen Announces CT041 CAR T-cell Product Candidate Granted RMAT Designation by the FDA

With the RMAT designation, CT041 enjoys all the benefits of Fast Track and Breakthrough Therapy designations including early and intensive FDA guidance on ...

January 11, 2022 | News

CanSinoBIO Announces Approval for its MCV4 Product Menhycia™ in China

Leveraging CanSinoBIO's industry-leading synthetic biotechnology and formulation technology platform, Menhycia™ covalently binds common pathogen...

January 10, 2022 | News

Taiwan FDA Has Accepted New Drug Application for Sacituzumab Govitecan

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

January 04, 2022 | News

FDA approved EAP manufacturing at the Catalent Texas site

BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leading developer of cellular therapies for neurodegenerative diseases, today announced plans for ...

January 03, 2022 | News

First Approval in Japan for the KEYTRUDA Plus LENVIMA Combination

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced that the Japanese Ministry of Health, Labour and Welfare (M...

December 29, 2021 | News

Japan Approves Molnupiravir for the Treatment of SARS-CoV-2 Infection

Japan’s Ministry of Health, Labor and Welfare Approves Molnupiravir for the Treatment of SARS-CoV-2 Infection Molnupiravir, First Oral COVID-19 Anti...

December 27, 2021 | News

WHO SAGE Issues Interim Recommendations for Novavax COVID-19 Vaccine

SAGE recommends additional third dose of NVX-CoV2373 administered to immunocompromised persons - Recommendation follows grant of WHO Emergency Use Li...

December 22, 2021 | News

WHO Supports Use of Johnson & Johnson COVID-19 Vaccine as a Booster

Johnson & Johnson (NYSE: JNJ) (the Company) today announced the interim recommendation by the Strategic Advisory Group of Experts on Immunization ...

December 10, 2021 | News

FDA Expands Eligibility for Pfizer-BioNTech COVID-19 Booster Dose to 16- and 17-Year-Olds

"Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces,...

December 10, 2021 | News

TOT BIOPHARM Announces NMPA Granted Marketing Approval

Bevacizumab is a humanized monoclonal antibody targeting vascular endothelial growth factor (VEGF) which can specifically bind to VEGF and block the bindin...

December 02, 2021 | News

Lunit's AI Software for Breast Cancer Detection, Wins FDA Clearance

Lunit, a leading medical AI provider, today announced that the US Food and Drug Administration (FDA) 510(k) has cleared its AI solution for breast cancer d...

November 19, 2021 | News

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