look into the history of this product, the FDA review (found here ), and the data in ..... whether the data for AFREZZA are adequate for FDA approval has now been answered (yes ..... substantially limited by the data in the FDA approved label, also known as the Prescribing
July 23 (Reuters) - The U.S. Food and Drug Administration said on Wednesday it has approved Gilead Sciences Inc's Zydelig, a drug to treat three types of blood cancer.
for prolonged exposure to the drugs without increased toxic effects. CPX-351, Celator's lead formulation, consists of FDA approved Cytarabine and Daunorubicin (1:5 ratio) and is currently in a Phase 3 trial in Acute Myeloid Leukemia (AML
profits, though likely not as quickly as some on the Street expect. I believe these shares can trade into the high teens with an FDA approval and favorable coverage decision, and I expect the second half of this year to be a pretty active period for the company
The U.S. regulator grants traditional approval for Gilead Sciences' ( GILD +0.4% ) Zydelig ( idelalisib ) as a treatment for chronic lymphocytic leukemia (CLL) that has relapsed. Zydelig is to used with Rituxan ( rituximab ) ( OTCQX:RHHBY +0.3% ) ( BIIB +11.6% ) in cases where Rituxan alone is ...
July 23 (Reuters) - The U.S. Food and Drug Administration has approved Gilead Inc's drug Zydelig to treat three types of blood cancer, the agency said on Wednesday.
for research. ArmaGen will be responsible for early- and mid-stage development while Shire will manage the late-stage work. The product candidate, AGT-182 , has been designated an Orphan Drug by the FDA and EMA. Post your comment!
and poor execution. Many of Silgan's cans use bisphenol A as an interior lining. Although the U.S. Food and Drug Administration currently allows the use of BPA in food packaging, there have been growing concerns about its impact on
Several restaurant and food-service firms have cut ties with meat supplier OSI this week amid a China Food and Drug Administration investigation into OSI subsidiary Shanghai Husi Food for allegedly supplying expired beef and chicken to Yum Brands
The FDA approves Eagle Pharmaceuticals' (NASDAQ: EGRX ) Ryanodex ( dantrolene sodium) injectable suspension for the treatment of malignant