Regulatory
This morning, Mylan announced the launch of its new generic offering, dimethyl fumarate delayed-release capsules for the treatment of relapsing forms of multiple sclerosis.
Shares of Poseida Therapeutics plunged more than 20% in premarket trading this morning after the company announced the U.S. Food and Drug Administration halted a cancer drug trial due to safety concerns.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 19, 2020.
The U.S. Food and Drug Administration approved Genentech’s Enspryng (satralizumab-mwge) as a subcutaneous treatment for adults with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 17, 2020.
With a busy August on the U.S. Food and Drug Administration’s schedule, this week is no exception. Here’s a look at some of what’s on the agency’s calendar.
Please check out the biopharma industry coronavirus (COVID-19) stories that are trending for August 14, 2020.
Passage Bio’s first attempt to develop a GM1 gangliosidosis gene therapy treatment has run into a roadblock in the form of a clinical hold.
The U.S. Food and Drug Administration (FDA) approved another therapy for Duchenne muscular dystrophy (DMD), this time NS Pharma’s Viltepso (viltolarsen).
Olinvyk is indicated for short-term intravenous use in hospitals or other controlled clinical settings, such as during inpatient and outpatient procedures.
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