FDA Grants First Full Approval to Pfizer-BioNTech COVID-19 Vaccine
The approval is indicated for individuals 16 years of age and older, however the vaccine remains available to those aged 12 years and older under the EUA.
All articles by Steve Duffy
Myrbetriq Approved for Pediatric Neurogenic Detrusor Overactivity
Both formulations are indicated for patients aged 3 years and older; however, the tablet formulation is specifically approved for patients weighing 35kg or more.
Ponvory Approved for Relapsing Forms of Multiple Sclerosis
Ponesimod is a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator.
Implantable Neurostimulation Device Approved for Chronic Low Back Pain
The FDA has approved ReActiv8® (Mainstay Medical), an implantable neurostimulation system, for the treatment of intractable chronic low back
Haymarket Medical Network Joins Ad Council Private Marketplace
Haymarket Medical Network, a part of business media company Haymarket Media, Inc., is proud to join the Ad Council’s first ever Private Marketplace (PMP) along with other partners Cadreon, The Trade Desk and Acxiom.
Fremanezumab Autoinjector Device Now Available for Migraine Prevention
Ajovy (fremanezumab-vfrm; Teva) is now available in an autoinjector device for the preventive treatment of migraine in adults.
DEA Deschedules Prescription CBD Drug Epidiolex
Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration.
FDA Approves OTC Combination of Ibuprofen and Acetaminophen
The FDA has approved the first OTC fixed-dose combination therapy containing ibuprofen and acetaminophen for the temporary relief of minor pain.
Test for Fragile X Syndrome Screening, Diagnosis Gets FDA Clearance
A diagnostic test for fragile X syndrome (FXS) has been cleared by the Food and Drug Administration.
Investigational Therapies Miss Primary End Point in Autosomal Dominant Alzheimer Disease Trial
Topline data were announced from the phase 2/3 DIAN-TU study of solanezumab (Eli Lilly) and gantenerumab (Genentech) in patients at risk for or with dominantly inherited Alzheimer disease.
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