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...
Kemin Industries has announced that the U.S. Patent and Trademark Office has granted the US 10,912,794 patent on the beta 1, 3 glucan for treating inflammation in the intestine and modulating human immune function. The patent approval comes after the US 9,574,217...
The U.S. Food and Drug Administration (FDA) approved Chiesi Global Rare Diseases’ Ferriprox for treating transfusional iron overload which is caused by sickle cell disease (SCD). The treatment is approved in patients three years old and older, and expands the...
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