Tag: FDA

Argenica Therapeutics’ ARG-007 gets FDA orphan drug status in hypoxic ischaemic encephalopathy

businessnewstoday- November 15, 2023

Argenica Therapeutics Limited (ASX: AGN), a leading biotechnology company specializing in developing therapeutics for brain injuries and neurological conditions, has achieved a significant milestone. The ... Read More

Lupin secures FDA nod for generic Bromday Ophthalmic Solution

businessnewstoday- August 16, 2023

Global pharmaceutical titan, Lupin Limited, has officially declared its success in securing the esteemed approval from the United States Food and Drug Administration (FDA). This ... Read More

Ayala Pharmaceuticals AL102 gets FDA fast track status in desmoid tumors

businessnewstoday- September 29, 2022

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

pallavi123- September 20, 2022

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

pallavi123- July 3, 2022

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

pallavi123- May 22, 2022

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

pallavi123- April 15, 2022

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

pallavi123- March 19, 2022

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

pallavi123- March 5, 2022

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

pallavi123- February 12, 2022

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