Browsing Tag
US Food and Drug Administration
336 posts
Solara Pharma’s manufacturing site garners positive FDA review
Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food…
Balfaxar receives FDA nod for treating acquired coagulation factor deficiency
Octapharma USA has announced the US Food and Drug Administration (FDA)’s approval of Balfaxar (prothrombin complex concentrate, human-lans),…
Aurobindo Pharma subsidiary receives FDA approval for Plerixafor Injection
Eugia Pharma Specialities Limited, a fully-owned subsidiary of India-based Aurobindo Pharma Limited, has received final approval from the…
FDA grants tentative approval to Lupin for Dolutegravir, Lamivudine, and Tenofovir Alafenamide Tablets
Lupin Limited, a leading global pharmaceutical company, has received tentative approval for its New Drug Application (NDA) for…
Lupin receives FDA nod for Chlorpromazine Hydrochloride Tablets
Lupin Inc., a wholly-owned subsidiary of the global pharmaceutical major Lupin Limited, announced that it has received approval…
FDA approves Gilead’s Veklury for COVID-19 patients with severe renal impairment
Gilead Sciences said that the US Food and Drug Administration (FDA) has approved a supplemental new drug application…
FDA accepts review of Dr. Reddy’s biosimilar rituximab candidate, DRL_RI
Dr. Reddy’s Laboratories, an Indian pharmaceutical company, announced that the US Food and Drug Administration (FDA) has accepted…
Lupin receives FDA establishment inspection report for Pithampur Unit-2
Global pharmaceutical corporation, Lupin Limited has received the Establishment Inspection Report (EIR) from the US Food and Drug…
280Bio initiates Phase 1 clinical study for YL-17231 after FDA approval
In a significant breakthrough for 280Bio, Inc., a clinical-stage biotechnology company, the US Food and Drug Administration (FDA)…
IPS HEART gets third FDA pediatric rare disease designation for ISX9-CPC
IPS HEART, a private cell therapy company developing treatments for Duchenne muscular dystrophy and heart failure, announced that…