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FDA approves Applied Pharmaceutical’s IND application for APS03118 pharmaceutical-business-review
January 24, 2022
The US Food and Drug Administration (FDA) has approved investigational new drug (IND) application for Applied Pharmaceutical Science’s next ...
FDA Limits Use of Two COVID Antibody Treatments drugs.com
January 24, 2022
The U.S. Food and Drug Administration is curtailing the use of two monoclonal antibody treatments that do not appear to work...
Regulus Therapeutics Announces Successful Completion of Pre-IND Meeting with FDA for RGLS8429 FirstWordPharma
January 21, 2022
Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs (the "Company" or "Regulus"), today announced that the Company...
Zydus receives final approval from US FDA for Vigabatrin tablets ExpressPharma
January 21, 2022
Vigabatrin is used to treat babies, one month to two years old with infantile spasms.
WuXi STA Opens Its First Parental Formulation Manufacturing Line contractpharma
January 21, 2022
Features multiple filling modules and a built-in lyophilizer to fill vials, syringes, and cartridges, as well as to produce lyophilized powders.
Fauci says FDA could authorize Pfizer's Covid vaccine for kids under 5 in the next month FirstWordPharma
January 20, 2022
White House chief medical advisor Anthony Fauci on Wednesday said the FDA could approve Pfizer and BioNTech's COVID-19 vaccine for children under 5-years-old in the next month, reported CNBC.
Strides Pharma’s Singapore arm gets US FDA nod for generic version of oseltamivir phosphate ExpressPharma
January 19, 2022
The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Tamiflu for oral suspension, 6 mg/mL, of Hoffmann-La Roche, Inc.
AstraZeneca-Daiichi Sankyo’s breast cancer therapy gets FDA priority review Pharmaceutical-Technology
January 19, 2022
The sBLA is based on results from the international, open-label Phase III DESTINY-Breast03 trial of Enhertu.
Improving Dose Selection In Children through Better Estimates of Renal Function FDA
January 19, 2022
CDER scientists are investigating how to improve pediatric dose selection by predicting drug clearance from renal function equations.
FDA Approves Rinvoq for Treatment of Atopic Dermatitis drugs.com
January 19, 2022
The U.S. Food and Drug Administration approved Rinvoq (upadacitinib) for the treatment of moderate-to-severe...

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