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February 22, 2023
This warning is the second on top of a previous warning not to purchase or use EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination.
Apellis Pharmaceuticals’ Syfovre is a pegcetacoplan injection intended for the treatment of geographic atrophy secondary to age-related macular degeneration.
February 17, 2023
Some noteworthy PSGs include dihydroergotamine mesylate nasal spray, glucagon nasal powder, afamelanotide subcutaneous implant, and triamcinolone acetonide injectable suspension.
The intention of the FOA is to address diverse topics related to improving the efficiency of biosimilar product development and advancing the development of interchangeable products.
February 13, 2023
After years of FDA issuing guidance documents and launching programs to encourage sponsors to seek broader representation in clinical trials, policy makers have added a “stick” to the process.
Pseudoephedrine is an oral treatment that can be used alone or in combination with other medicines to treat nasal congestion resulting from a cold, flu, or allergy.
The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.
February 09, 2023
Biden outlined a host of priorities for improving health care and building the economy during State of the Union address.
February 07, 2023
Clinicians, pediatric patients, regulators, and more are being considered to further strengthen focus on unmet medical needs.
The change would impact every package and hundreds of systems.