Approvals
The FDA approval marks the first for oral ulcers associated with Behçet’s Disease and the third for Otezla.
Phase 1/2 trial to be HOOKIPA’s first clinical trial in immuno-oncology
The U.S. Food and Drug Administration (FDA) issued a complete response letter (CRL) to AstraZeneca over its supplemental New Drug Application (sNDA) for Farxiga (dapagliflozin) as an adjunct treatment to insulin for type 1 diabetes (T1D) when insulin alone doesn’t keep blood sugar levels under control.
The FDA approval marks the first drug approved for Azurity, a company formed from the merger of CutistPharma and Silvergate.
SonoCloud ultrasound device for glioblastoma patients will be tested for first time at US clinical sites
Da Volterra, a clinical-stage biopharmaceutical company developing new therapeutics to protect the intestinal microbiota, announced the completion of patient recruitment for its Phase 2 trial ‘SHIELD’ evaluating DAV132 in patients receiving antibiotics.
Shares of Karyopharm Therapeutics have skyrocketed more than 36% after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s treatment for multiple myeloma.
As fireworks illuminate the night skies across the United States this weekend in celebration of Independence Day, BioSpace takes a look at some of the highlights of the pharma industry from the first half of 2019 and earlier that provides millions of patients with the independence of health.
Retrophin, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved 100 mg and 300 mg tablets of THIOLA® EC (tiopronin), a new enteric-coated formulation of THIOLA® (tiopronin), to be used for the treatment of cystinuria, a rare inherited disorder that causes a buildup of cystine levels in the urine resulting in the formation of recurring cystine kidney stones.
The month of July is a slow one for the U.S. Food and Drug Administration (FDA), at least in terms of scheduled approval dates. Here’s a look at the three PDUFA dates the agency has on its calendar for the month.
PRESS RELEASES