Sonofi and Sobi get Altuviiio FDA approval to treat hemophilia A
Sonofi and Sobi have secured the approval of the US Food and Drug Administration (FDA) for their Altuviiio for hemophilia A treatment. Altuviiio, previously known ... Read More
Zydus Lifesciences gets FDA final approval for Pitavastatin Tablets
Zydus Lifesciences said that it has bagged final approval for Pitavastatin Tablets, 1mg, 2mg, and 4mg from the US Food and Drug Administration (FDA). Pitavastatin ... Read More
Moderna, Merck get FDA breakthrough status for mRNA-4157/V940, KEYTRUDA combo in melanoma
Moderna and Merck announced that the investigational personalized mRNA cancer vaccine mRNA-4157/V940 in combination with the latter’s lung cancer drug KEYTRUDA (pembrolizumab) has been given ... Read More
Zydus Lifesciences gets FDA tentative approval for Gabapentin Tablets
Zydus Lifesciences said that its subsidiary Zydus Pharmaceuticals (USA) has secured tentative approval for once-daily Gabapentin Tablets, 300 mg and 600 mg from the US ... Read More
Teva Pharmaceutical gets FDA approval for AUSTEDO XR for TD and HD
Teva Pharmaceutical Industries said that its US affiliate Teva Pharmaceuticals has secured approval for AUSTEDO XR (deutetrabenazine) extended-release tablets from the US Food and Drug ... Read More
Zydus Lifesciences gets FDA final approval for Rapamune generic – Sirolimus Tablets
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) for Sirolimus Tablets, 1 mg and 2 mg, which is the ... Read More
GSK secures full Jemperli FDA approval for endometrial cancer treatment
Biopharma company GSK has secured the full approval of the US Food and Drug Administration (FDA) for its Jemperli (dostarlimab-gxly) drug for recurrent or advanced ... Read More
Gilead gets Trodelvy FDA approval for pre-treated HR+/HER2- metastatic breast cancer
Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Trodelvy (sacituzumab govitecan-hziy) for pre-treated HR+/HER2- metastatic breast cancer. The ... Read More
GSK gets Jesduvroq FDA approval for anaemia of chronic kidney disease
GSK has secured the approval of the US Food and Drug Administration (FDA) for the company’s Jesduvroq (daprodustat) for anaemia of chronic kidney disease (CKD) ... Read More
FDA approves Guardant360 CDx assay as companion diagnostic for Menarini’s ORSERDU for metastatic breast cancer
Guardant Health, an oncology company, has secured the approval of the US Food and Drug Administration (FDA) for the company’s Guardant360 CDx liquid biopsy assay ... Read More