Browsing Tag
US FDA
379 posts
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…
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…
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…
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 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…
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…
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…
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…
Zydus Lifesciences gets FDA tentative approval for Levothyroxine Sodium generic
Zydus Lifesciences (previously Cadila Healthcare), through its US subsidiary Zydus Pharmaceuticals (USA), has secured tentative approval for Levothyroxine…
CSL Behring gets Hemgenix FDA approval for hemophilia B
CSL Behring, a US-based biotechnology company, has received approval for its Hemgenix (etranacogene dezaparvovec-drlb) from the US Food…