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
Phase 3 Trial Results of Ruxolitinib in COVID-19 Associated ARDS Announced
Patients were randomized to receive either ruxolitinib 5mg twice daily (BID) plus standard of care (SoC), ruxolitinib 15mg BID plus SoC or placebo plus SoC.
First OTC Molecular COVID-19 Test Gets EUA for At-Home Use
The test correctly identified 96% of positive samples from individuals known to have symptoms and 100% of positive samples from individuals without symptoms.
COVID-19 Vaccine: The Path to Development
Since January 2020, when China shared the whole genome sequence, researchers have been working tirelessly to create a potential vaccine.
Zoonotic Diseases: How COVID-19 Could Alter Our Preparedness for Future Pandemics
The impact of COVID-19 on the global health system and economy will likely result in large-scale changes in zoonotic disease prevention preparedness.
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.
Exebacase Gains Breakthrough Therapy Status for MRSA Bacteremia, Including Right-Sided Endocarditis
Exebacase is a novel, recombinantly-produced lysin (cell wall hydrolase enzyme), that targets the peptidoglycan cell wall.
Investigational Antibiotic Gets Orphan Drug Status for Pulmonary Exacerbations of Cystic Fibrosis
The FDA has granted Orphan Drug designation to ARV-1801 (sodium fusidate; Arrevus) for the treatment of pulmonary exacerbations in patients with cystic fibrosis.
Vaccine to Prevent Ricin Intoxication Gets Fast Track Status
The FDA has granted Fast Track designation to RiVax® for the prevention of ricin intoxication.
Recarbrio Gets Priority Review for Hospital-Acquired, Ventilator-Associated Bacterial Pneumonia
The FDA has accepted for review a sNDA for Recarbrio™, to treat adult patients with hospital-acquired and ventilator-associated bacterial pneumonia.
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