Gilead Sciences gets Sunlenca FDA approval for multi-drug resistant HIV
Sunlenca FDA approval : Gilead Sciences has secured the approval of the US Food and Drug Administration (FDA) for Sunlenca (lenacapavir), in combination with other ... Read More
Genentech gets Actemra FDA approval for COVID-19 in hospitalized adults
Actemra FDA approval : Genentech, a subsidiary of Roche, has received the approval of the US Food and Drug Administration (FDA) for Actemra (tocilizumab) intravenous ... Read More
Abiomed gets FDA nod for Impella ECP pivotal heart pump in clinical trial
The US Food and Drug Administration (FDA) has cleared Abiomed to use the company’s version of Impella ECP pivotal heart pump in pivotal clinical trial. ... Read More
Ferring bags Adstiladrin FDA approval in non-muscle invasive bladder cancer
Swiss biopharmaceutical company Ferring Pharmaceuticals has received approval for its Adstiladrin (nadofaragene firadenovec-vncg) gene therapy from the US Food and Drug Administration (FDA) for the treatment ... Read More
Zydus Lifesciences gets FDA final approvals for Silodosin and Pregabalin capsules
Zydus Lifesciences (formerly known as Cadila Healthcare) has secured final approvals from the US Food and Drug Administration (FDA) for Silodosin Capsules, 4 mg and ... Read More
FDA grants EUA for Omicron-adapted Covid-19 vaccine for children below five
Pfizer and BioNTech have received the US Food and Drug Administration (FDA) emergency use authorization (EUA) for their Omicron BA.4/BA.5-adapted bivalent Covid-19 vaccine for children ... Read More
Alembic Pharmaceuticals gets FDA final approval for Desonide Cream, 0.05%
Alembic Pharmaceuticals has secured final approval for its abbreviated new drug application (ANDA) of Desonide Cream, 0.05% from the US Food and Drug Administration (FDA). ... Read More
Rigel Pharmaceuticals gets Rezlidhia FDA approval for AML
Rigel Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for its Rezlidhia (olutasidenib) capsules for relapsed or refractory (R/R) acute myeloid ... Read More
Zydus Lifesciences gets FDA approval for Estradiol Transdermal System
Zydus Lifesciences (previously Cadila Healthcare) has secured final approval for Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day, and 0.1 mg/day ... Read More
Ferring Pharmaceuticals gets Rebyota FDA approval for recurring CDI
Rebyota FDA approval : Ferring Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for Rebyota (fecal microbiota, live-jslm), a microbiota-based live ... Read More