BioPharma Drug Approval

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

FDA Pre-Submission for Saliva-Based Glucose Test to Replace Invasive Finger-Prick

The purpose of this Pre-Submission is to confirm with the FDA the clinical trial design, including trial objectives. This interaction will allow the FDA to...

 October 20, 2021 | News

MSN Labs Launches Empagliflozin tablets at an affordable price for Diabetes Management in India

‘EMPAONE’ is intended to provide diabetes patients in need across India with an affordable and accessible therapeutic option. India being the d...

 October 19, 2021 | News

Dr. Reddy's Laboratories Announces the Launch of Carmustine for Injection

  The BiCNU® brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 a...

 October 18, 2021 | News

FDA Approves Innovative Treatment for Pediatric Patients with Congenital Athymia

"Today's action marks the first FDA approval of a therapy to treat this very rare and devastating disease in children," said Peter Marks, M.D., Ph.D.,...

 October 11, 2021 | News

Japan Approves Pfizer’s CIBINQO® to treat Atopic Dermatitis

Pfizer Inc. (NYSE: PFE) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved CIBINQO® (abrocitinib), ...

 October 04, 2021 | News

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