Pharma News

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...

Gilead Sciences’ Kite Pharma has received FDA’s approval for its retroviral vector manufacturing facility in Oceanside, Calif.

The FDA has approved GlaxoSmithKline’s Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis) vaccine for immunization during the third trimester of pregnancy to prevent pe...

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 20...

The FDA has granted a priority review to Takeda’s supplemental Biologics License Application (sBLA) for Takhzyro (lanadelumab-flyo) for prevention of attacks of hereditary edema in children under...

Eli Lilly has received FDA’s Fast Track designation for tirzepatide for treatment of adults with obesity or who are overweight with weight-related comorbidities. ...

The FDA has granted a Fast Track designation to Immutep’s eftilagimod alpha in combination with pembrolizumab for treatment of first-line nonsmall-cell lung cancer (NSCLC). ...