FDA
The FDA’s approval of Eli Lilly’s obesity drug Zepbound intensifies an already heated battle with Novo Nordisk’s Wegovy in the lucrative weight-loss drug market, as other drugmakers hope to get a piece of the action.
FEATURED STORIES
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
After a leading study caused the FDA to slap its most stringent warning on hormone replacement therapies for menopause more than two decades ago, the regulator is changing course in what FDA Commissioner Marty Makary called a “historic day for women in the United States.”
The upheaval of the Health and Human Services workforce and leadership leaves much to be desired in terms of delivery, recently retired FDA Chief Information Officer Vid Desai tells BioSpace, but the regulatory agency is evolving to be more open to much needed change.
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Moderna has made the official request to the FDA to approve its COVID-19 for use in children ages 6 months to 5 years. Moderna also announced the location of its first non-U.S. mRNA manufacturing facility.
In its 2022 Q1 earnings report, Sanofi reported major wins in the first quarter of 2022, driven mostly by the success of consumer healthcare (CHC) and Dupixent.
Alexion shared the news that Ultomiris (ravulizumab-cwvz) has been approved by the FDA for commercialization, adding another indication for the precedent-setting drug.
Exogene nets $2 million to propel the development of its AI platform for T-cell receptor discovery and Healome spins out to deploy a ‘pro-healing’ platform with a focus on ocular surface diseases.
AviadoBio is celebrating orphan drug designations from both the U.S. FDA and the European Commission for AVB-101, a gene therapy intended to treat frontotemporal dementia (FTD).
The FDA has now approved the first treatment for COVID-19 in young children, expanding its approval for Gilead’s Veklury to children who are at least 28 days old and weigh at least three kilograms.
Bristol Myers Squibb will hear from the FDA on April 28 about Mavacamten, while Supernus, Axsome, Coherus, Hutchmed and Incyte also await the fate of their respective drug candidates.
Ampio shares continue to fall following the company’s announcement that the FDA rejected proposed changes to a Phase III study of its treatment for osteoarthritis of the knee and other joints.
RMAT designation means a faster, more streamlined approval process and frequent communication with FDA representatives. The FDA recently granted RMAT Designations to both Direct Bio and AlloVir.
The U.S. FDA’s Oncologic Drugs Advisory Committee is holding a meeting on April 21, 2022, to discuss safety findings across the entire class of PI3K inhibitors for hematological cancers.