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This approval marks the first new initial treatment option for this difficult-to-treat type of lung cancer in more than 20 years.
Allergan, which has been a leader in the migraine space, hopes to have a new treatment available for patients using a new mechanism of action for acute treatment of migraine.
It’s a busy week for the U.S. Food and Drug Administration (FDA) with quite a number of pending drug approvals, several of which were delayed for a variety of reasons. Here’s a look.
During his relatively brief tenure as Commissioner of the U.S. Food and Drug Administration (FDA), Scott Gottlieb has worked to streamline and advance guidelines for clinical trials. As something of a parting shot, Gottlieb made a statement criticizing the industry’s reluctance to take advantage of them.
The White House budget proposal released earlier this week that slashed spending on the National Institutes of Health and Medicare programs has put members of the administration, including Health and Human Services Secretary Alex Azar on the defensive.
The FDA, as part of efforts to update clinical trial eligibility criteria, published four draft guidance documents on cancer clinical trial criteria and one final draft on adolescents in adult oncology trials.
The U.S. Food and Drug Administration (FDA) approved Aerie Pharmaceuticals Rocklatan (netarsudil and latanoprost ophthalmic solution) to decrease elevated intraocular pressure (IOP) in open-angle glaucoma or ocular hypertension.
Medical device company receives second FDA clearance, adding blood flow monitoring technology to portfolio
The FDA issues Warning Letters to biopharma, medical device and food companies when they find that a manufacturer has significantly violated FDA regulations. As of March 4, the agency issued 45 Warning Letters this year.
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