Tag: FDA

Aura Biosciences gets FDA fast track status for belzupacap sarotalocan

businessnewstoday- July 3, 2022 0

Aura Biosciences has secured fast track designation for belzupacap sarotalocan (AU-011) from the US Food and Drug Administration (FDA) for the treatment of non-muscle invasive ... Read More

Glenmark issued FDA Form 483 for Monroe formulation manufacturing facility

businessnewstoday- May 22, 2022 0

Glenmark Pharmaceuticals said that it has been issued Form 483 with 17 observations by the US Food and Drug Administration (FDA) following an inspection at ... Read More

BriaCell Therapeutics’ Bria-IMT gets FDA fast track status in breast cancer

businessnewstoday- April 15, 2022 0

BriaCell Therapeutics has secured the fast track status from the US Food and Drug Administration (FDA) for its lead candidate — Bria-IMT for the treatment ... Read More

FDA refuses to approve AstraZeneca’s sBLA for Fasenra in CRSwNP

businessnewstoday- March 19, 2022 0

The US Food and Drug Administration (FDA) has refused to approve the supplemental biologics license application (sBLA) of AstraZeneca’s asthma drug Fasenra (benralizumab) for the ... Read More

Pfizer gets FDA breakthrough status for RSVpreF RSV vaccine candidate

businessnewstoday- March 5, 2022 0

Pfizer has secured breakthrough therapy designation for its respiratory syncytial virus (RSV) vaccine candidate — PF-06928316 (RSVpreF) from the US Food and Drug Administration (FDA) ... Read More

Lilly gets FDA EUA for bebtelovimab in mild-to-moderate Covid-19

businessnewstoday- February 12, 2022 0

Eli Lilly and Company (Lilly) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for bebtelovimab for the treatment of ... Read More

Alembic Pharmaceuticals gets FDA approval for Toviaz generic

businessnewstoday- February 2, 2022 0

Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for ... Read More

Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022

businessnewstoday- November 13, 2021 0

Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal pegcetacoplan to the US Food and Drug ... Read More

Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks

businessnewstoday- September 6, 2021 0

Welspun India Limited, a Mumbai-based home textile company, has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for its 3 Ply ... Read More

Zydus Cadila gets FDA tentative approval for Sitagliptin base tablets

businessnewstoday- September 6, 2021 0

Zydus Cadila said that its subsidiary has been granted tentative approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) ... Read More