FDA approves first new antibiotic for UTIs in nearly 30 years
The FDA approved a new antibiotic for UTIs from drugmaker GSK. The drug, Blujepa, is for women and girls ages 12 and up.
BioPharma Dive20h
FDA misses approval deadline for Novavax’s COVID-19 vaccine
The delayed decision comes amid a major organizational shakeup that included the departure of top vaccine official Peter ...
US FDA approves Amgen's Uplizna as first treatment for rare immune disorder
The U.S. Food and Drug Administration has approved expanded use of Amgen's drug, Uplizna, to help reduce the risk of flares ...
Fierce Biotech2d
Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
Here’s what to know about Blujepa, the new FDA-approved UTI treatment heading to market this year
GSK's pill, the first oral antibiotic for urinary tract infections in almost 30 years, comes as bacteria are increasingly ...
JD Supra3d
Federal Circuit Finds Against Generics Where Hatch-Waxman's Full Five-Year Extension Fixes Delay For Pharmaceutical FDA-Review
argued that instead of the maximum 5-year PTE resulting from the period between December of 2003 (original issuance) to December 2015 (FDA approval), Merck should have only been entitled to a PTE ...
UPI10d
FDA approves new drug to treat protein buildup in the heart
The U.S. Food and Drug Administration has approved a new drug for ... But the treatment comes at a steep price. Each dose costs about $119,000, or $476,000 per year. That's more than double ...
The American Journal of Managed Care13d
FDA Approves Guselkumab for Adult Patients With Crohn Disease
The FDA has approved guselkumab (Tremfya) as the first IL-23 inhibitor offering both subcutaneous and intravenous induction ...