Shares of Reata Pharmaceuticals Inc. soared 175% to hit a one-year high in early trading on Wednesday, after the U.S. Food and Drug Administration (FDA) approved its rare disease drug and ended years of uncertainty over its future.
Gilead Sciences Inc. said on Friday the U.S. Food and Drug Administration had greenlighted expanded use of Trodelvy to treat the most common type of breast cancer, marking the third approval for the drug.
The FDA greenlit AstraZeneca’s anti-CTLA-4 antibody tremelimumab in combination with its checkpoint inhibitor Imfinzi as a treatment for patients with unresectable hepatocellular carcinoma (HCC), the most common type of liver cancer.
The FDA approved bluebird bio’s lentiviral vector (LVV) eli-cel Friday as the first therapy to slow the progression of neurologic dysfunction in juvenile boys with early, active cerebral adrenoleukodystrophy (CALD).
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu has been approved by the U.S. Food and Drug Administration as the first HER2-directed medicine for patients with HER2-mutant metastatic NSCLC, a particularly lethal form of the disease.
The drug received priority review and breakthrough therapy designations for the indication, and approval was granted to Daiichi Sankyo four months ahead of the Prescription Drug User Fee Act deadline.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, adding that the approval fulfills a significant unmet need for patients with severe alopecia areata.