Lupin subsidiary gets FDA approval for Fluocinolone Acetonide Oil
Lupin Limited said that their wholly-owned US subsidiary, Novel Laboratories Inc., has secured approval from the US Food and Drug Administration (US FDA) for its ... Read More
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 and Drug Administration (US FDA). Following an ... Read More
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), a treatment for urgent reversal of acquired ... Read More
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 US Food and Drug Administration (FDA). This ... Read More
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 Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets from ... Read More
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