Food and Drug Administration (FDA)
NEWS
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.
In addition to patent cases, partnerships and pledging money to global tropical disease efforts, Novartis scored a win on a combo-treatment for solid tumors.
AbbVie filed a supplemental New Drug Application with the U.S. Food and Drug Administration seeking approval for Qulipta for the preventative treatment of migraine.
Krystal Biotech announced that it submitted a Biologics License Application to the FDA for its candidate B-VEC, intended for the treatment of dystrophic epidermolysis bullosa.
Gelesis’ weight loss device, Plenity, has been gaining popularity since the FDA approved its commercialization, but some in the medical community question whether its popularity is deserved.
Precision BioSciences and Novartis are teaming up to develop a potential cure for hemoglobinopathies such as sickle cell disease and beta-thalassemia.
On Wednesday, the FDA approved Merck’s pneumococcal 15-valent conjugate vaccine for children 6 weeks through 17 years of age.
Acer Therapeutics and Relief Therapeutics announced the FDA has denied their NDA for ACER-001 (sodium phenylbutyrate) for the treatment of urea cycle disorders.
Three physicians filed a lawsuit against the FDA alleging the organization acted outside its authority and with their ability to practice medicine by discouraging the use of ivermectin to treat COVID-19.
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