Food and Drug Administration (FDA) Clinical Trials Food and Drug Administration (FDA) RSS feedThis is an RSS file. You can use it to subscribe to this data in your favourite RSS reader or to display this data on your own website or blog.

FDA Orders Important Safety Labeling Changes for Addyi Regarding Alcohol Consumption
April 11, 2019 -- The U.S. Food and Drug Administration today issued a safety labeling change order to Sprout Pharmaceuticals for their drug, Addyi (flibanserin), that requires the company to revise important safety information that women and their... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 11, 2019 Category: Pharmaceuticals Source Type: clinical trials

Daiichi Sankyo Provides Update on Ongoing FDA Review for Quizartinib for Treatment of Patients with Relapsed/Refractory FLT3-ITD AML
Tokyo and Basking Ridge, NJ– (April 4, 2019)– Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) has extended the review period for the New Drug Application... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 9, 2019 Category: Pharmaceuticals Source Type: clinical trials

Immunocore ’s Lead Asset Tebentafusp Gains Fast Track Designation for Metastatic Uveal Melanoma
OXFORD, England& CONSHOHOCKEN, Pa.--April 03, 2019 --Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for its... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 4, 2019 Category: Pharmaceuticals Source Type: clinical trials

Selumetinib Granted U.S. Breakthrough Therapy Designation in Neurofibromatosis Type 1
KENILWORTH, N.J.--(BUSINESS WIRE) April 1, 2019 --AstraZeneca and Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 1, 2019 Category: Pharmaceuticals Source Type: clinical trials

Selumetinib Granted US Breakthrough Therapy Designation in Neurofibromatosis Type 1
1 April 2019 AstraZeneca and Merck& Co., Inc., Kenilworth, NJ, US (known as MSD outside the US and Canada) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for the investigational... (Source: Drugs.com - Clinical Trials)
Source: Drugs.com - Clinical Trials - April 1, 2019 Category: Pharmaceuticals Source Type: clinical trials