FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy
Agency initiates safety label change and notifies physicians of possible link
Agency initiates safety label change and notifies physicians of possible link
All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec
Clinical evidence has consistently highlighted lacosamide’s efficacy and safety.
Yesafili, available in vial and prefilled syringe presentations (2 mg/0.05 mL), was the first biosimilar to Eylea approved by Health Canada
Keytruda Qlex is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute
The Phase Ib MAD study is a randomized, double-blind, placebo-controlled trial conducted in the United States
The inspection concluded with zero form 483 observations
Wegovy achieved significant weight loss with one in three study participants losing 20% or more body weight
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