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BioPharma Drug Approval

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

Novavax and Serum Institute of India Receive EUA for COVID-19 Vaccine in Indonesia

"The first authorization of Novavax' COVID-19 vaccine exemplifies our commitment to equitable global access and will fill a vital need for Indonesia, ...

November 02, 2021 | News

Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia

-- Application marks the first protein-based COVID-19 vaccine submitted to regulatory authorities for provisional approval in Australia --...

November 01, 2021 | News

Medigen's MVC-COV1901 Selected for WHO COVID-19 Solidarity Trial Vaccines

The announcement by WHO, comes after the approval from WHO Ethics Review Committee and relevant regulatory authorities and ethics committees of&n...

October 27, 2021 | News

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