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.

First Chinese HIV drug is approved for human clinical trials in USA

clinical trials
Chinese first domestically-made anti-HIV drug has been given approval by the US Food and Drug Administration (FDA) to begin the next phase of clinical trials in America.

Viela Bio begins its first-in-human clinical trial

lab
Viela Bio announced the start of the company's first clinical trial, a phase 1, first-in-human clinical trial of VIB9600, which is being developed for the treatment of immune mediated diseases.

EMA and FDA will conduct workshop on PRIME and Breakthrough Therapy schemes

eu-us
EMA and FDA launched PRIME and Breakthrough Therapy schemes to strengthen their support to the development of medicines for unmet medical needs to help patients to benefit from these therapies as early as possible.

Indian pharma companies obtained 125 FDA approvals during H1 2018

pills
Indian Pharma companies and their subsidiaries have received 125 final ANDA approvals from US FDA during the first half ended June 2018 out of total 323 Abbreviated New Drug Applications approvals.

Samsung BioLogics gets FDA approval to manufacture a monoclonal antibody drug

samsung biologics
Samsung BioLogics announced that it has been licensed by the US FDA to manufacture a monoclonal antibody Drug Product (DP) at its first plant. The company did not disclose the name of the product.

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)