Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors
Ayala Pharmaceuticals has been granted fast track designation for its oral gamma-secretase inhibitor AL102 by the US Food and Drug Administration (FDA) for the treatment ... Read More
Lupin Limited launches Generic Suprep Bowel Prep Kit in the US
Indian pharma company Lupin Limited has launched Sodium Sulfate, Potassium Sulfate and Magnesium Sulfate Oral Solution, 17.5 g/3.13 g/1.6 g per 6 ounces, after getting ... Read More
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 (FDA) for the treatment of non-muscle invasive ... Read More
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 17 observations by the United States Food ... Read More
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 lead candidate — Bria-IMT for the treatment ... Read More
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 AstraZeneca’s asthma drug Fasenra (benralizumab) for the ... Read More
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 the US Food and Drug Administration (FDA) ... Read More
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 (FDA) for bebtelovimab for the treatment of ... Read More
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 its abbreviated new drug application (ANDA) for ... Read More
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 pegcetacoplan to the US Food and Drug ... Read More