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.

FDA approved first smallpox drug to protect against bioterrorism threat

fda office
Though the WHO declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980, there have been longstanding concerns that smallpox could be used as a bioweapon.

Dr Reddy’s recalls Atorvastatin Calcium from US market

drreddys
Dr Reddy's Laboratories, an Indian multinational pharmaceutical company, is recalling from the USA over 236 000 bottles of Atorvastatin Calcium tablets used for lowering cholesterol.

EMA and FDA accepted regulatory submissions for Pfizer’s cancer drug

cancer treatment
Pfizer announced that the FDA granted Priority Review designation to the company’s New Drug Application for talazoparib. The European Medicines Agency has also accepted the Marketing Authorization Application for talazoparib.

Samsung Biologics biggest plant received FDA approval

samsung biologics
Samsung BioLogics announced that a third monoclonal antibody Drug Substance has been licensed by the US FDA (Food and Drug Administration) for its second plant, the world’s largest single plant.

Swiss pharma companies are suspected of hampering generics development

fda
The United States Food and Drug Administration published a list of pharmaceutical companies, all of which are suspected of hindering the development of generic versions of their own medicines.

Thermo Fisher signed new agreements with Daiichi Sankyo and Takeda

thermo-fisher
Thermo Fisher Scientific announced it has signed new agreements with Daiichi Sankyo and Takeda Pharmaceuticals designed to expand the clinical utility of Oncomine Dx Target Test in support of clinical trials and drug development.

FDA approved GW Pharmaceuticals cannabis-based drug Epidiolex

epidiolex
If approved, Epidiolex would be the first pharmaceutical formulation of purified, plant-based CBD, a cannabinoid lacking the high associated with marijuana, and the first in a new category of anti-epileptic drugs (AEDs).

FDA delays approval of Teva and Celltrion biosimilar drug due to manufacturing issues

fda office
According to a statement on Celltrion’s website, the FDA has requested supplementary information about the products.

EMA and FDA accepted Pfizer’s submission for a review of lung cancer drug

pfizer
Pfizer announced that the U.S. FDA accepted the company’s New Drug Application and granted priority review for dacomitinib. EMA has also accepted the Marketing Authorization Application for dacomitinib for the same indication.

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

fda
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

fda
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

bayer
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

lab
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