The $26,500-per-year price tag for Eisai Co. Ltd. and Biogen Inc.’s newly approved Alzheimer’s disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said.
Ocugen Inc. said on Monday the COVID-19 vaccine developed by its Indian partner Bharat Biotech International Ltd. met the main goals of a trial in the United States.
BrainStorm Cell Therapeutics concluded 2022 on a cautiously optimistic note as the FDA granted a Type A meeting to discuss the refuse to file letter it served the Israel and New York-based biotech in November for its ALS hopeful, NurOwn. On Wednesday, the company made a series of C-suite moves in what could be a show of confidence in NurOwn’s ability to prevail.
The U.S. Food and Drug Administration (FDA) will allow retail pharmacies to offer abortion pills in the United States for the first time, the agency said on Tuesday, even as more states seek to ban medication abortion.
The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.
Ardelyx, Inc. announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH
TG Therapeutics Inc. said on Wednesday that the U.S. health regulator had approved its monoclonal antibody for treating patients with relapsing forms of multiple sclerosis, sending its shares up 47% in afternoon trade.
The U.S. Food and Drug Administration (FDA) is planning to make recommendations on how to regulate the use of popular cannabis compound CBD in food and supplements, the Wall Street Journal reported on Tuesday, citing agency officials.
BrainStorm Cell Therapeutics Inc., a leading developer of adult stem cell therapeutics for neurodegenerative diseases, announced that the U.S. Food and Drug Administration (FDA) has granted a Type A meeting to discuss the contents of a refusal to file letter previously issued regarding the company’s New Biologics License Application (BLA) for NurOwn for the treatment of ALS. The Type A Meeting has been scheduled to occur on January 11, 2023.
The U.S. Food and Drug Administration on Friday changed the label for the emergency contraception known as Plan B One-Step to make clear that the pill does not alter the course of an existing pregnancy.