Tag: Food & Drug Administration
Pfizer Sends First Data to FDA on COVID-19 Vaccines for Younger Children
Agency has said it could authorize a vaccine for younger children in a matter of weeks after receipt of trial data
FDA Approves Pfizer Booster Shots for Seniors, High-Risk Americans
Exactly who qualifies as high risk because of health or work reasons is not yet clear
First Biosimilar Approved for Macular Degeneration, Other Eye Conditions
Biosimilar to Lucentis approved to treat neovascular age-related macular degeneration, macular edema, myopic choroidal neovascularization
Precedent Needed for FDA Approval Decisions When Evidence Lacking
In seven of 22 cases, approval used new interpretations of original evidence and did not require new evidence
FDA Panel Says Yes to Pfizer Booster Shots for People 65+
Same independent panel of experts said no to booster shots for Americans younger than 65 years
FDA Advisory Panel to Hold Meeting Today on COVID-19 Booster Shots
Advisory panel will review a variety of evidence, including new data from Israel
FDA Tells Three Small E-Cigarette Makers to Stop Selling Flavored Products
Agency says companies have not provided 'sufficient evidence' that any possible public health benefits of e-cigarettes outweigh the risks
FDA Approves First Nerve-Stimulation Device to Aid Stroke Recovery
Vivistim System is a prescription therapy for ischemic stroke patients who have moderate-to-severe difficulty moving their arms and hands
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
