Tag: US Food and Drug Administration
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 from the United States Food and Drug ... Read More
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 (sNDA) for Veklury (remdesivir) usage in COVID-19 ... Read More
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 its Biologics License Application (BLA) for a ... Read More
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 Administration (FDA) for its Pithampur Unit-2 facility ... Read More
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) has given the green light to its ... Read More
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 it has received a third Rare Pediatric ... Read More
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 its Abbreviated New Drug Application (ANDA) for ... Read More
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 Oxcarbazepine tablets in strengths of 150 mg, ... Read More
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 the United States. This marks the first ... Read More
Zydus Lifesciences secures tentative FDA approval for Palbociclib Tablets
Zydus Lifesciences Limited, along with its subsidiaries and affiliates, has announced that it has been granted tentative approval by the US Food and Drug Administration ... Read More