Approvals
Hikma Pharmaceuticals generic version of Advair has hit a stumbling block with the FDA.
The U.S. Food and Drug Administration has approved Trogarzo (ibalizumab), the first HIV-1 inhibitor for patients with multi-drug resistant HIV-1.
There is a newly approved treatment for pediatric patients with major depressing episodes associated with bipolar disorder.
The U.S. Food and Drug Administration (FDA) approved the first-ever direct-to-consumer genetic test for cancer risk.
The U.S. Food and Drug Administration (FDA) expanded the dosing schedule for Bristol-Myers Squibb’s Opdivo (nivolumab).
Shares of Prometic Life Sciences Inc. jumped this morning after securing the U.S. Food and Drug Administration’s Rare Pediatric Disease Designation.
The U.S. Food and Drug Administration (FDA) issued new draft guidance for preclinical trials in Alzheimer’s.
Asthma patients may soon have a new treatment option.
Sorrento Therapeutics, Inc. nabbed regulatory approval for ZTlido, a non-opioid pain treatment in the form of a super-sticky patch.
Shares of Portola Pharmaceuticals are falling after the company announced a delay of several months for possible regulatory approval of its Factor Xa-inhibitor antidote, AndexXa.
PRESS RELEASES