NOVARTIS CORPORATION: Novartis announces FDA approval of Gilenya® as the first disease-modifying therapy for pediatric relapsing multiple sclerosis

Novartis today announced that the US Food and Drug Administration (FDA) has approved Gilenya® (fingolimod) for the treatment of children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis, making it the first disease-modifying therapy indicated for these patients2. Read More »

PFIZER: Pfizer Granted FDA Breakthrough Therapy Designation for TRUMENBA® (Meningococcal Group B Vaccine) for the Prevention of Invasive Meningococcal B Disease in Children Ages 1 to 9 Years

Pfizer Inc. announced that TRUMENBA® (Meningococcal Group B Vaccine) received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for active immunization to prevent invasive disease caused by Neisseria meningitidis group B (MenB) in children ages 1 through 9 years. Read More »

ACORDA THERAPEUTICS, INC.: Acorda to Present New Data For INBRIJA™ (levodopa inhalation powder) at 70th American Academy of Neurology Annual Meeting

Acorda Therapeutics, Inc. will present new data for INBRIJA during four oral platform presentations at the upcoming American Academy of Neurology Annual Meeting in Los Angeles, taking place April 21–27, 2018. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen. Read More »

NOVARTIS CORPORATION: The McCourty Twins & Friends Shine a Spotlight on Sickle Cell Disease

Imagine having a chronic disease that affects almost every organ in your body and can lead to intense, debilitating pain episodes that often send you to the ER.1,2 What’s more, there are generally no warning signs, making it difficult to not only plan ahead for special events, but to keep up with the day-to-day activities most people take for granted. Too often, this is a recurring cycle for people with sickle cell disease (SCD). Read More »

ACORDA THERAPEUTICS, INC.: Announces FDA Acceptance of New Drug Application for INBRIJA™ (levodopa inhalation powder)

Acorda Therapeutics, Inc. (Nasdaq:ACOR) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for INBRIJA. INBRIJA is an investigational inhaled levodopa treatment for symptoms of OFF periods in people with Parkinson’s disease taking a carbidopa/levodopa regimen Read More »

PHIZER: Receives Breakthrough Therapy Designation from FDA for PF-04965842, an oral JAK1 Inhibitor, for the Treatment of Patients with Moderate-to-Severe Atopic Dermatitis

Pfizer Inc. announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Read More »