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.
AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.
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.
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.
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.
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.
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.
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.
The US Food and Drug Administration (FDA) has approved Libtayo to be used for the treatment of patients having two of the most common skin cancers in the US.
Novartis has announced that the novel investigational treatment asciminib, specifically targeting the ABL myristoyl pocket (STAMP), has been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA).
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