Browsing Tag
FDA
341 posts
Lupin launches generic Suprep Bowel Prep Kit in the US after FDA approval
Lupin launches FDA-approved generic Suprep Bowel Prep Kit in the US, entering a $202M market and expanding its gastrointestinal portfolio.
Aura Biosciences gets FDA fast track status for belzupacap sarotalocan
Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration…
Glenmark Pharmaceuticals receives FDA Form 483 with 17 observations for North Carolina facility
Glenmark Pharmaceuticals, a global pharmaceutical company based in India, announced that it has been issued Form 483 with…
BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer
BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its…
FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP
The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of…
Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate
Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from…
Lilly gets FDA EUA for bebtelovimab in mild-to-moderate Covid-19
Eli Lilly and Company (Lilly) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration…
Alembic Pharmaceuticals gets FDA approval for Toviaz generic
Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for…
Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022
Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal…
Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks
Welspun India Limited, a Mumbai-based home textile company, has secured 510 (k) clearance from the US Food and…