Imfinzi approved in the EU for less-frequent, fixed-dose use in unresectable non-small cell lung cancer
New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience
New option extends dosing from two to four weeks, reducing medical visits and improving patient convenience
Pfizer announced that the U.S. Food and Drug Administration (FDA) approved the supplemental New Drug Application (sNDA) for XALKORI (crizotinib) for the treatment of pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive.
Novartis has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for its ligelizumab (QGE031) to treat chronic spontaneous urticarial.
Bayer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) and granted Priority Review for finerenone, an investigational drug for patients with chronic kidney disease (CKD) and type 2 diabetes (T2D).
GSK and Medicines for Malaria Venture (MMV) announced today that the Australian Therapeutic Goods Administration (TGA) accepted the submission of a Category 1 application to extend the indication of single-dose Kozenis (tafenoquine) to paediatric populations for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria.
Inversago Pharma, the peripheral CB1 blockade company, announced the U.S. Food and Drug Administration (FDA) granted a Rare Pediatric Disease (RPD) designation to the Company’s lead compound, INV-101, for the treatment of Prader-Willi syndrome (PWS).
RedHill Biopharma announced that RHB-204 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for its development as a potential first-line, stand-alone, oral treatment of pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex (MAC) – a rare disease for which there is no FDA-approved first-line therapy.
Moderna has secured conditional marketing authorisation (CMA) from the European Commission (EC) for mRNA vaccine called Covid-19 Vaccine Moderna.
CURE Pharmaceutical Holding, a technology focused, vertically integrated drug delivery and product development company in the pharmaceutical and health & wellness space, announced today that the U.S. Food and Drug Administration (FDA) has approved an Investigational New Drug (IND) application for its product CUREfilm Blue, an oral soluble film of sildenafil citrate (the active ingredient present in Viagra®1) for the treatment of erectile dysfunction (ED).
Roche has secured a breakthrough therapy designation from the US Food and Drug Administration (FDA) for tiragolumab plus Tecentriq (atezolizumab) to treat PD-L1-high non-small cell lung cancer (NSCLC).