Bio/Pharma News

FDA Grants Quanterix Plasma Test Breakthrough Device Designation

May 04, 2022

FDA granted Quanterix’s neurofilament light chain plasma test a breakthrough device designation as a prognostic aid for relapsing-remitting multiple sclerosis.

Migraine Treatment Granted Marketing Authorization by European Commission

May 03, 2022

VYDURA has been granted marketing authorization by the European Commission for both acute treatment of migraine and prophylaxis of episodic migraine.

Moderna Submits EUA of COVID-19 Vaccine for Use in Young Children

May 02, 2022

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

ENHERTU Granted Breakthrough Therapy Designation in US

May 02, 2022

ENHERTU has been granted breakthrough therapy designation in the US for patients with HER2 low metastatic breast cancer.

FDA Grants RMAT Designation to Autolus’ CAR-T Cell Therapy

May 02, 2022

FDA has granted regenerative medicine advanced therapy (RMAT) designation to Autolus’ CAR-T cell therapy obe-cel.

USPTO Issues Malaria Vaccine Patent to GeoVax

April 27, 2022

GeoVax has received a patent for its malaria vaccine from the US Patent and Trademark Office.

Pfizer and BioNTech Submit EUA Application for Pediatric COVID-19 Vaccine Booster Dose

April 27, 2022

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

Johnson & Johnson Launches Next Satellite Center for Global Health Discovery

April 26, 2022

Johnson & Johnson has launched its next Satellite Center for Global Health Discovery at Holistic Drug Discovery and Development Centre, University of Cape Town.

Tremelimumab Accepted Under Priority Review in the US

April 26, 2022

Tremelimumab has been accepted under priority review in the US for patients with unresectable liver cancer in combination with Imfinzi.

FDA Approves Veklury for Treatment of COVID-19 in Pediatric Patients

April 25, 2022

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.