Browsing Tag
US FDA
379 posts
Can Glenmark Pharmaceuticals’ tentative FDA nod for Regadenoson Injection boost its US generics momentum?
Glenmark Pharmaceuticals secures FDA tentative approval for Regadenoson Injection, targeting a USD 660M U.S. cardiac stress agent market.
Strides Pharma Science gets FDA approval for Tamiflu generic
Strides Pharma Science Limited said that Strides Pharma Global Pte. Limited, Singapore, its step-down fully-owned subsidiary, has secured…
Alembic Pharmaceuticals gets FDA approval for Doryx Tablets generic
Alembic Pharmaceuticals has bagged final approval from the US Food and Drug Administration (FDA) for its abbreviated new…
Novartis gets Leqvio FDA approval for reducing bad cholesterol levels
Novartis has secured approval from the US Food and Drug Administration (FDA) for its small interfering RNA (siRNA)…
FDA issues warning letter to Medtronic diabetes business
Medtronic said that it has been issued a warning letter from the US Food and Drug Administration (FDA)…
Sun Pharmaceutical wins FDA approval for generic Amphotericin B Liposome
Sun Pharmaceutical Industries said that one of its fully-owned subsidiaries has secured final approval from the US Food…
Lupin gets EIR with voluntary action indicated from FDA for Goa facility
Lupin Limited said that it has been issued the establishment inspection report (EIR) from the US Food and…
Cadila Healthcare gets FDA nod for phase 2(b)/3 trial of saroglitazar magnesium
Cadila Healthcare (Zydus Cadilla) said that it has obtained permission from the US Food and Drug Administration (FDA)…
Ocugen secures FDA clearance to begin OCU400 gene therapy trial: What this means for patients with retinitis pigmentosa
Find out how Ocugen’s FDA-approved OCU400 trial is shaping the future of gene therapy for retinitis pigmentosa. Read the full story today.
Cytokinetics bags FDA breakthrough therapy status for aficamten in oHCM
Cytokinetics has secured breakthrough therapy designation from the US Food and Drug Administration (FDA) for aficamten for the…