News Releases
FDA Okays Headband for Migraines
Today, the U.S. Food and Drug Administration allowed marketing of the first device as a preventative treatment for migraine headaches.
Lemtrada Fails to Win Approval from FDA for MS Rx
A new multiple sclerosis medication has failed to win FDA approval.
FDA Approves Label Changes for Anti-Seizure Drug Potiga
The US Food and Drug Administration (FDA) has approved changes to the drug label of the anti-seizure drug Potiga ( ezogabine ), underscoring risks of abnormalities to the retina in the eye, potential vision loss, and skin discoloration, all of which may become permanent.
FDA Approves Second Brain Imaging Rx for Alzheimer’s Disease, Dementia Evaluation
The US Food and Drug Administration today approved Vizamyl ( flutemetamol F 18 injection), a radioactive diagnostic drug for use with positron emission tomography (PET) imaging of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.
FDA Approves Extended-Release, Single-Entity Hydrocodone Product
The US Food and Drug Administration today approved Zohydro ER (hydrocodone bitartrate extended-release capsules) for the management of pain severe enough to require daily, around-the-clock, long-term treatment and for which alternative treatment options are inadequate.
New Drug Application for Amitiza Approved
Sucampo Pharmaceuticals, Inc. and Takeda Pharmaceuticals USA, Inc. announced today that the FDA has approved Sucampo’s supplemental new drug application (sNDA) for AMITIZA ® (lubiprostone) (24 mcg twice daily) as the first and only oral medication for the treatment of opioid-induced constipation (OIC) in adult patients with chronic, non-cancer pain.
New Rx May Improve Quality of Life for Parkinson’s Pisease
Three studies released today present possible positive news for people with Parkinson’s disease.
Cerebral Palsy Doesn’t Stop Teen From Excelling in Sports
If you ask most people if having a partial paralysis would hinder you from pursuing sports, the answer might be yes. But they might think twice if they met 16-year-old Joe Cancilla of Walled Lake, MI.
Multiple Sclerosis Rx Approved by FDA
EMD Serono , Inc., a subsidiary of Merck KGaA , Darmstadt , Germany, and Pfizer Inc. announced today that the US Food and Drug Administration (FDA) approved Rebif ® Rebidose ® (interferon beta-1a ), a single-use auto-injector for the self-administration of Rebif , a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).
Biogen to Discontinue Development of ALS Drug
Biogen Idec reported top-line results of EMPOWER, a Phase 3 trial investigating dexpramipexole in people with amyotrophic lateral sclerosis (ALS). The trial did not meet its primary endpoint, a joint rank analysis of function and survival, and no efficacy was seen in the individual components of function or survival.