Eisai Co. Ltd. and Eli Lilly and Co. on April 8 said they still plan to seek accelerated U.S. approval for experimental Alzheimer’s drugs even after the Medicare health plan decided to severely limit coverage of medicines approved in that manner.
Drugmakers AstraZeneca and Amgen said on July 8 their experimental drug tezepelumab was granted a speedy review by the U.S. Food and Drug Administration for potential approval as a treatment for asthma.
Shares of Epizyme stock rose after the company’s first-in-class EZH2 inhibitor Tazverik won approval from the U.S. Food and Drug Administration for the second time in 2020.
Immunomedics Inc. won an accelerated approval from the U.S. Food and Drug Administration for Trodelvy, a therapy for a form of invasive breast cancer that has worsened despite two prior rounds of treatment.
Epizyme’s oral potent, first-in-class EZH2 inhibitor tazemetostat won accelerated approval from the U.S. Food and Drug Administration for the treatment of adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Roche Holding AG’s Tecentriq immunotherapy in combination with Avastin and chemotherapy won U.S. Food and Drug Administration approval as a first-line treatment for a type of lung cancer.
Roche’s Tecentriq will get a speedy review by U.S. regulators in a tough-to-treat form of breast cancer, seeking to be the first company to have an immunotherapy win approval in this indication.
U.S. health regulators approved Amicus Therapeutics’ Galafold as the first oral therapy to treat Fabry disease, a rare and sometimes fatal condition.
The FDA approved Azedra injection for intravenous use for treating patients age 12 and older with rare tumors of the adrenal gland that cannot be surgically removed, have spread beyond the original tumor site and require systemic anticancer therapy.
The U.S. Food and Drug Administration granted Roche an accelerated review for the Swiss drugmaker’s Elecsys product used to diagnose Alzheimer’s disease.