The U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer and BioNTech COVID-19 vaccine to now include young teens between 12 and 15 years of age. Previously, the EUA was approved for patients 16 years of age and older,...
The U.S. Food and Drug Administration (FDA) has granted ConforMIS Inc. 510(k) clearance for its Identity Imprint™ Knee Replacement System. Available in both posterior stabilized (PS) and cruciate retaining (CR) versions, the system expands the range of options for...
China’s regulatory body, the National Medical Products Administration (NMPA), has granted conditional approval to BeiGene’s PARP inhibitor pamiparib for treatment of patients advanced ovarian cancer. The approval marks the first for pamiparib and the third...
The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the early detection of oral and throat cancer through their proprietary mRNA technology in combination with Viome’s next-gen AI platform. The first-of-its-kind tool...
Pfizer & BioNTech’s COVID-19 vaccine is expected to receive FDA approval for adolescents ages 12 and older sometime this week. The expected approval comes from a Phase III trial in adolescents between the ages of 12 and 15 with 2,260 participants that...
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