Browsing Tag
US Food and Drug Administration
348 posts
Zydus Lifesciences bags FDA final approval for Apixaban Tablets
Zydus Lifesciences has bagged final approval from the US Food and Drug Administration (FDA) for Apixaban Tablets, 2.5mg…
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…
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…
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…
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…
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…
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…
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…
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)…
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)…