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.
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AstraZeneca has voluntarily withdrawn the Imfinzi (durvalumab) indication for adult patients who received treatment earlier in the US for locally advanced or metastatic bladder cancer.
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.
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).
Global biopharmaceutical company Bristol Myers Squibb (BMS) has received US Food and Drug Administration (USFDA) approval for its new CD19-directed chimeric antigen receptor (CAR) T cell therapy Breyanzi (lisocabtagene maraleucel; liso-cel).
AstraZeneca has secured a conditional marketing authorisation for its Covid-19 vaccine in the European Union (EU) for active immunisation in individuals aged 18 years and above.
AstraZeneca announced that it has secured regulatory approval from China’s National Medical Products Administration (NMPA) for Symbicort Turbuhaler, an anti-inflammatory reliever to relieve symptoms of mild asthma.
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