Approvals
Shares of Rigel Pharmaceuticals shot up about 40 percent during Thursday trading due primarily to an error on the company’s website that claimed its drug candidate Tavalisse had gained approval from the U.S. Food and Drug Administration (FDA).
The U.S. Food and Drug Administration (FDA) approved Amgen’s supplemental Biologic License Application (sBLA) for Blincyto (blinatumomab) to treat adults and children with B-cell precursor acute lymphoblastic leukemia (ALL) under specific circumstances.
The U.S. Food and Drug Administration (FDA) approved Mylan NV’s Symfi (efavirnenz, lamivudine and tenofovir disoproxil fumarate) for adult and pediatric HIV-1 patients.This marks the third HIV approval for the company.
The U.S. Food and Drug Administration (FDA) accepted Bristol-Myers Squibb’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) with Yervoy (ipilimumab) for a type of colorectal cancer.
Seattle Genetics announced today that the FDA has granted approval for its Adcetris drug to treat Hodgkins Lymphoma.
The FDA granted a Priority Review designation to Pfizer and partner Astellas Pharma for expanded use of Xtandi in prostate cancer treatment.
On April 23, the FDA’s arthritis advisory committee will take another look at Eli Lilly’s re-submission for their moderate-to-severe rheumatoid arthritis drug.
A U.S. Food and Drug Administration announced their decision to slap a clinical hold on Solid Biosciences Inc.’s experimental gene therapy treatment for Duchenne muscular dystrophy.
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.
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