The European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for Pfizer and OPKO’s somatrogon, for review.
01 Mar 2021
25 Feb 2021
Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.
24 Feb 2021
Pharmaceutical company Pfizer has announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for priority review for TicoVac, a tick-borne encephalitis (TBE) vaccine.
23 Feb 2021
AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.
22 Feb 2021
Biopharmaceutical company Dynavax Technologies (DVAX) has secured marketing authorisation from the European Commission (EC) for Heplisav B, a two-dose adult hepatitis B adjuvanted vaccine.
19 Feb 2021
The U.S. Food and Drug Administration (FDA) has granted efanesoctocog alfa – earlier termed BIVV001 (rFVIIIFc-VWF-XTEN) – Fast Track Designation (FTD) for the treatment of patients suffering from hemophilia A.
17 Feb 2021
Swiss pharmaceutical company Novartis has secured the expanded US Food and Drug Administration (FDA) indication for Entresto, a Novartis therapy to treat patients diagnosed with guideline-defined heart failure.
16 Feb 2021
South Korean biopharmaceutical company Celltrion Healthcare has secured European Commission (EC) marketing authorisation for the sale of Yuflyma (CT-P17) for the treatment of multiple chronic inflammatory diseases.
12 Feb 2021
Global leader in antibiotics and a division of Swiss multinational pharma company Novartis, Germany-based Sandoz has signed a contract to acquire GlaxoSmithKline’s (GSK) cephalosporin antibiotics.
10 Feb 2021
The U.S. Food and Drug Administration (FDA) has approved Emergency Use Authorization (EUA) for investigational bamlanivimab and etesevimab as a combination therapy for the treatment of mild to moderate Covid-19 patients.