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
Welireg Approved for Cancers Associated With Von Hippel-Lindau Disease
The approval was based on data from an open-label phase 2 study which evaluated the efficacy and safety of Welireg in patients with von Hippel-Lindau-associated renal cell carcinoma and other VHL-associated tumors.
Empagliflozin Under Review for Heart Failure With Reduced Ejection Fraction
The sNDA is supported by data from the phase 3 EMPEROR-Reduced trial which compared the efficacy and safety of empagliflozin to placebo, in addition to recommended therapy, in 3730 patients with chronic heart failure with reduced ejection fraction.
Mirabegron Granted Priority Review for Neurogenic Detrusor Overactivity
The submissions are supported by data from a phase 3 study that evaluated mirabegron in 91 patients aged 3 to 17 years with NDO on clean intermittent catheterization.
NIH: Study Will Identify Most Promising Therapies for COVID-19
So far, the therapies scheduled to be part of the trial are risankizumab, an interleukin-23 antagonist, and lenzilumab, an anti-human granulocyte macrophage-colony stimulating factor monoclonal antibody.
Phase 3 Trial of COVID-19 Vaccine Candidate mRNA-1273 Begins
The trial, which is the first to be implemented under Operation Warp Speed, is expected to enroll around 30,000 adults and will be conducted at multiple clinical research sites across the US.
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.
Procysbi Delayed-Release Oral Granules Now Available in Packets
Horizon Therapeutics announced the availability of Procysbi (cysteamine bitartrate) delayed-release oral granules in tear-open packets for the treatment of nephropathic cystinosis in patients aged 1 year and older.
Seven Things to Consider When Transitioning to Telemedicine During COVID-19
The use of telemedicine has been surging since the onset of coronavirus disease 2019 (COVID-19), with millions of Americans now using this medium for connecting with their clinicians, according to a report that appeared in Kaiser Health News.1 The increase in use of this modality can be attributed to fears of contracting COVID-19, social distancing…
ABIM Relaxes MOC Requirements Due to COVID-19
The American Board of Internal Medicine (ABIM) announced that certified physicians who have a Maintenance of Certification (MOC) requirement due in 2020 will now have until the end of 2021 to complete it.
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