Investigational Alzheimer Disease Treatment Granted Fast Track Status
The FDA granted lecanemab Breakthrough Therapy designation back in June, 2021.
All articles by Steve Duffy
Podcast: Infectious Diseases Physician Dr Joshua Barocas Talks About COVID-19 Variants and Vaccines
To get a better understanding of the situation and how the future months could unfold, MPR sat down with Joshua Barocas, MD, an Assistant Professor of Medicine at the Boston University School of Medicine and Infectious Diseases physician at Boston Medical Center.
FDA Clamps Down on Companies Selling Hangover Treatments
None of the products mentioned in the warning letters have been evaluated by the FDA for their intended uses.
Aristada, Vivitrol Access Expanded During COVID-19 Pandemic
Alkermes has decided to expand the number of retail pharmacies and clinics where patients can receive access to Aristada (aripiprazole lauroxil) and Vivitrol (naltrexone extended-release injectable suspension).
Haymarket Medical Network Joins Ad Council Private Marketplace
Haymarket Medical Network, a part of business media company Haymarket Media, Inc., is proud to join the Ad Council’s first ever Private Marketplace (PMP) along with other partners Cadreon, The Trade Desk and Acxiom.
DEA Deschedules Prescription CBD Drug Epidiolex
Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration.
Somryst, A Prescription Digital Therapeutic for Chronic Insomnia, Gets FDA Nod
The FDA has approved Somryst™ (Pear Therapeutics), a prescription digital therapeutic (PDT) intended for the treatment of patients 22 years of age and older with chronic insomnia.
Investigational Therapies Miss Primary End Point in Alzheimer Disease Trial
Topline data were announced from the phase 2/3 DIAN-TU study of solanezumab (Eli Lilly) and gantenerumab (Genentech) in patients at risk for or with dominantly inherited Alzheimer disease.
Infinity DBS System Gains Expanded Approval for Parkinson Disease Management
The FDA has approved an expanded indication for the Infinity™ Deep Brain Stimulation (DBS) system (Abbott) to include targeting the internal globus pallidus, which may lead to symptom improvement in patients with Parkinson disease.
FDA to Review Novel Antipsychotic for Schizophrenia, Bipolar I Disorder
The FDA has accepted for review the New Drug Application (NDA) for ALKS 3831 (Alkermes) for the treatment of schizophrenia and bipolar I disorder.
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