News from the FDA/CDC
News from the FDA/CDC
FDA approves Wakix for excessive daytime sleepiness
The efficacy of pitolisant (Wakix) was evaluated in a pair of multicenter, randomized, double-blind, placebo-controlled studies.
FDA/CDC
HHS proposes pathways for drug importation
Officials at the U.S. Department of Health and Human Services have announced a new plan that they say would lay the foundation for safe...
FDA/CDC
FDA approves first generics of pregabalin
The first generic approvals of the drug were granted to nine companies.
News from the FDA/CDC
ACIP approves meningococcal booster for persons at increased risk
Committee recognizes challenges of meningococcal outbreaks on college campuses.
FDA/CDC
FDA approves bevacizumab-bvzr for several cancers
The bevacizumab biosimilar is now approved for metastatic colorectal cancer, advanced non-squamous non–small cell lung cancer, recurrent...
Latest News
FDA approves first treatment for neuromyelitis optica spectrum disorder
The Food and Drug Administration has approved Soliris (eculizumab) injection for IV use for the treatment of neuromyelitis optica spectrum...
News from the FDA/CDC
Stewart Tepper: Emgality approval ‘very exciting’
The treatment binds to calcitonin gene-related peptide and is the first therapy to reduce the frequency of episodic cluster headache attacks.
FDA/CDC
Insomnia meds get boxed warning from FDA
Although complex sleep behaviors, such as sleep walking, associated with these medications are rare, the consequences can be deadly.
News from the FDA/CDC
CDC warns against misuse of opioid-prescribing guideline
Officials at the Centers for Disease Control and Prevention are advising against misapplication of the agency’s guideline on opioid prescribing....
News from the FDA/CDC
FDA concerned about e-cigs/seizures in youth
Between 2010 and early 2019, the FDA and poison control centers received 35 reports of seizures that mentioned the use of e-cigarettes
News from the FDA/CDC
FDA approves Mavenclad for treatment of relapsing MS
Cladribine (Mavenclad) is the first short-course oral therapy for adult patients with relapsing/remitting or active secondary progressive MS.