Pharma News

Rigel Pharmaceuticals decided to not file a supplemental New Drug Application (sNDA) for fostamatinib in the treatment of patients with warm autoimmune hemolytic anemia, an autoimmune disorder tha...

The FDA has granted Priority Review to Regeneron’s supplemental Biologics License Application (sBLA) for its blockbuster drug Eylea (aflibercept), as an injection in the proposed treatment for pr...

Aptar Pharma has added another element to its suite of digital support tools for patients as they make their journey through the healthcare system.

The FDA has granted Eligo Bioscience Orphan Drug and Rare Pediatric Disease designations for its investigational gene therapy EB003 for treating patients with Shiga-toxin producing bacterial infec...

A compound that both inhibits the MRSA superbug and renders it more vulnerable to antibiotics has been discovered by scientists at the University of Bath led by Dr. Maisem Laabei and Dr. Ian Blagbr...

The FDA has accepted Gilead Sciences’ supplemental Biologics License Application (sBLA) of Trodelvy (sacituzumab govitecan-hziy) for Priority Review in treating patients with unresectable locall...

Nanoscope Therapeutics has received FDA’s Fast Track designation for its MCO-010, an investigational gene therapy for treatment of retinitis pigmentosa, a group of inherited diseases causing reti...

The FDA has approved scPharmaceuticals’ Furoscix (furosemide injection) for treatment of congestion due to fluid overload in adults with chronic heart failure. ...

An intranasal formulation of AstraZeneca’s widely-used COVID-19 vaccine Vaxzevria has failed at the first hurdle, after results from a phase 1 trial found it was unable to stimulate a strong immu...

The FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) are teaming up with the Critical Path Institute (C-Path) for a “pre-consortiumâ...

Montreal, Canada-based Theratechnologies has received FDA’s approval for Trogarzo (ibalizumab-uiyk) for administration by intravenous (IV) push.

The FDA has approved Alnylam Pharmaceuticals’ supplemental new drug application (sNDA) for Oxlumo (lumasiran) to treat primary hyperoxaluria type 1 by lowering plasma oxalate levels in adult and...