Tag: Food & Drug Administration
Moderna Readies for Full Vaccine Approval, as Pfizer Submits Data on Booster Shot
Right now, Moderna vaccine only authorized for emergency use in Americans 18+ years; Pfizer boosters available to immunocompromised
Pfizer-BioNTech COVID-19 Vaccine Receives Full FDA Approval
Prescribing information includes warning about risks for myocarditis and pericarditis, particularly in men younger than 40 years
FDA: Stop Using Eco-Med Ultrasound Gels, Lotions
Health care providers, facilities should stop using and discard all ultrasound gels and lotions due to risk for bacterial contamination
Xywav Gets FDA Approval to Treat Rare Sleep Disorder
First drug to be approved by the agency for idiopathic hypersomnia
Enzyme Replacement Therapy Approved for Late-Onset Pompe Disease
Patients taking Nexviazyme saw improvements in respiratory function and walking distance measures
REGEN-COV Authorized for Postexposure Prophylaxis in High-Risk Individuals
Emergency use authorization indicated for those who have been exposed to SARS-CoV-2 and have an immunocompromising condition
Full Approval of Pfizer COVID-19 Vaccine Could Come in September
FDA said in a statement that its leaders recognized that full approval might counter vaccine hesitancy
Report Questions Benefit of FDA Accelerated Approval Pathway
112 of the 253 authorized drugs have not been confirmed as clinically effective; 24 of these have been on market more than five years
FDA Approves First Biosimilar Insulin Product
Semglee (insulin glargine-yfgn) is biosimilar to and interchangeable with Lantus (insulin glargine), provides cost-effective option
FDA to Prioritize Full Approval for Pfizer COVID-19 Vaccine
Full approval could help boost vaccination efforts in the United States
