Browsing Tag
US Food and Drug Administration
333 posts
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…
Lupin gains tentative FDA approval for Dolutegravir Tablets generic
Indian pharmaceutical company Lupin announced that the US Food and Drug Administration (FDA) has granted tentative approval for…
Zydus Lifesciences gets FDA final approval for Oxcarbazepine tablets
Zydus Lifesciences has secured final approval from the US Food and Drug Administration (FDA) to produce and sell…
Endo International introduces Noxafil generic version in US
Endo International has revealed that its Par Sterile Products division is now shipping posaconazole injection (18 mg/mL) in…