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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

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