GlaxoSmithKline Halts RSV Vaccine Trials in Pregnant Women
The setback for GlaxoSmithKline comes amid a multicompany race to develop a vaccine against respiratory syncytial virus infections.
FDA Approves Pyrukynd, the First Disease-Modifying Treatment for Hemolytic Anemia in Adults with Pyruvate Kinase Deficiency
Pyrukynd, developed by Agios Pharmaceuticals, is a PK activator and the first in this drug class. The company is also awaiting approval by the European Medicines Agency, and a decision is expected by the end of 2022.
Bayer Receives FDA Fast-Track Designation for Next-Generation Anticoagulant
Asundexian is an oral factor XIa inhibitor currently under phase 2 trials for potential secondary thrombosis prevention in patients with non-cardioembolic ischemic stroke, atrial fibrillation, or recent myocardial infarction.
FDA Approves Fleqsuvy, a Concentrated Baclofen Oral Suspension, for the Treatment of Spasticity in Patients with Multiple Sclerosis
The oral formulation of the muscle relaxant was also approved as a treatment for spasticity associated with spinal cord injuries.
Pfizer-BioNTech to Apply for FDA EUA for Their COVID-19 Vaccine in Children Ages 6 Months Through 4 Years of Age
Pfizer and BioNTech initiated an application yesterday (Feb. 1) for emergency use authorization (EUA) of their COVID-19 vaccine for children ages 6 months through 4 years.
FDA Approves Quviviq, New DORA for Treatment of Insomnia in Adults
The dual orexin receptor antagonist (DORA) from a Swiss drugmaker will be available in May 2022.
Xarelto Becomes the First DOAC FDA-Approved for Use in Pediatric Patients After Fontan Procedure
The Janssen drug is the only DOAC available in an oral suspension, which facilitates pediatric weight-based dosing.
Dupixent Has Company. The FDA Has Approved Another Biologic for the Treatment of Atopic Dermatitis.
Leo Pharma's Adbry (tralokinumab-ldrm) is the second, FDA-approved biologic for atopic dermatitis. Dupixent (dupilumab) was the first.
FDA Approves First-in-Class Therapy to Lower LDL Cholesterol
Leqvio (inclisiran) is the first small interfering RNA therapy approved to lower LDL cholesterol in certain adults at risk for life-threatening cardiovascular events.
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