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Drug Approval

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

PARACRINE Receives Full FDA Approval to Launch Pivotal Trial in Diabetic Foot Ulcer Patients

Pivotal trial to support marketing approval of regenerative cells processed with the Celution® System to commence in Q1 2022 Paracrine, Inc. ann...

November 18, 2021 | News

FDA Approves Treatment for Rare Blood Disease

Today, the U.S. Food and Drug Administration approved Besremi (ropeginterferon alfa-2b-njft) injection to treat adults with polycythemia vera, a blood dise...

November 15, 2021 | News

Hetero and Shenzhen Beimei Pharmaceuticals launch antiviral drug Oselavir® in China

Hetero, a globally renowned vertically integrated pharmaceutical organization and Shenzhen Beimei Pharmaceuticals jointly announced that they have received...

November 12, 2021 | News

FDA Clears Pharmaxis Cancer Drug to Progress to Phase 2 Study in Liver Cancer

Clinical stage drug development company Pharmaxis Ltd (ASX: PXS) today announced that an Investigational New Drug application (IND) for a trial of PXS-5505...

November 10, 2021 | News

Molnupiravir, an Oral COVID-19 Antiviral Medicine, Receives First Authorization in the World

Applications Remain Under Review by Other Regulatory Authorities, Including U.S. Food and Drug Administration and the European Medicines Agency Merck (NYS...

November 08, 2021 | News

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