The FDA subsequently allowed imports of the cancer drug from China, from Qilu Pharmaceutical, whose version of the drug is unapproved in the U.S. Georgia’s elected officials are asking the FDA ...
New FDA Orphan Drugs: CDX-110, ATryn, ISIS 333611 The FDA has granted orphan drug designation to CDX-110 for the treatment of glioblastoma multiforme, ATryn for the treatment of hereditary ...
An Israeli company that has a U.S. headquarters in Waltham said Monday it has received approval for a new drug for blood cancer. Biopharmaceutical company BioLineRx Ltd. (Nasdaq: BLRX) said the U ...
A Bristol Myers drug that treats anemia caused by a type of blood cancer now has an FDA approval that moves it up in the hierarchy of treatments, expanding the eligible patient population and ...
Ahead of a Feb. 10 advisory panel meeting, regulators say pivotal trial of pixantrone was too small; they also express concern about heart safety of drug. Ahead of a Feb. 10 advisory panel meeting ...
FDA is banning the import of some produce and dairy products from areas surrounding the Fukushima Daiichi nuclear plant affected by the March 11 earthquake and tsunami. FDA is banning the import ...
The Food and Drug Administration is now regularly approving new drugs after just one or two clinical trials — a significant departure from the more rigorous vetting process the agency was ...
An Israeli company developing treatments for cancers and rare disease said Monday it has received approval for a new drug after completing clinical trials in partnership with Washington University.
WASHINGTON — Florida governor and presidential hopeful Ron DeSantis has ballyhooed a high-profile plan to import prescription drugs from Canada, even suing the Biden administration for allegedly ...
(MENAFN- PR Newswire) SINGAPORE, Sept. 11, 2023 /PRNewswire/ -- On September 9th, 2023, Biosyngen Pte Ltd (hereafter as "Biosyngen") announced that the U.S. FDA has cleared the Investigational New ...
A group of advisers to the Food and Drug Administration voted in favor of Alnylam Pharmaceuticals’ treatment for a debilitating heart disease Wednesday, but only after a day-long debate ...
FDA Approves Clobazam Add-On for Lennox Syndrome The benzodiazepine is already available in 100 other countries, marketed under different brand names. News, October 24, 2011 Orphan Drug Status for ...
