Tag: FDA

The Food and Drug Administration (FDA or USFDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.

Sun Pharma obtained FDA approval for its biologics drug

sun pharma
Sun Pharma announced that the U.S. FDA has approved its biologics drug Ilumya (Tildrakizumab) for the treatment of adults with moderate-to-severe plaque psoriasis.

Novo Nordisk filed the approval submissions for a long-acting factor VIII

Novo Nordisk
Novo Nordisk announced the submission of a Biologics License Applications (BLA) to the US Food and Drug Administration (FDA) and a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA)

US FDA warned OTC drug manufacturers from China and Hong Kong

The US Food and Drug Administration released warning letters sent to two over-the-counter drugmakers in China (Zhejiang Ludao Technology) and Hong Kong Zhejiang (Nan San).

FDA published its updated Guidance on Systemic Antibacterial Drugs

The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development.

Bayer received a warning letter from FDA

The German drugmaker, which is taking over U.S. seed maker Monsanto, is addressing the FDA’s complaints regarding manufacturing practices, which stem from a routine inspection in January.

Biocartis and Amgen sign a development agreement

Biocartis Group NV, an innovative molecular diagnostics company from Belgium, announced the signing of a companion diagnostic development agreement with Amgen

FDA gave approval to the first digital drug

digital drug
FDA approves Abilify MyCite, a pill with a sensor that digitally tracks if patients have ingested their medication

Mutual recognition agreement between EU and US brought into action

1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States

FDA allows eight European authorities to conduct GMP inspections

us eu
U.S. Food and Drug Administration will recognize eight European drug regulatory authorities as capable of conducting inspections of manufacturing facilities

FDA aknowledged hemophilia gene therapy as Breakthrough Designation

BioMarin Pharmaceutical Inc. announced that the U.S. Food and Drug Administration granted valoctocogene roxaparvovec Breakthrough Therapy Designation

FDA approved second gene therapy product

gene therapy
The U.S. Food and Drug Administration yesterday approved Yescarta, a cell-based gene therapy

Samsung Biologics achieved FDA approval for its largest plant

samsung biologics
Samsung BioLogics announced that it has been licensed by the US FDA for the first monoclonal antibody Drug Substance at its second plant, the world's largest single plant

FDA approved first cancer biosimilar Mvasi

fda office
The U.S. Food and Drug Administration today approved Mvasi as a biosimilar to Avastin for the treatment of multiple types of cancer.

FDA approved first cancer gene therapy from Novartis

fda office
The U.S. Food and Drug Administration issued a historic action today making the first gene therapy available in the United States

EC, EMA and FDA signed a new milestone commitment

The European Commission, the United States Food and Drug Administration and the European Medicines Agency have signed a new confidentiality commitment that allows the US regulator to share non-public and commercially confidential information

ACF Bioservices accomplished the construction of cGMP-compliant facility

good laboratory practice
ACF Bioservices announces the completion of construction on its dedicated cGMP-compliant 3400 square foot facility for gene and cell therapy product testing