Oral Treatment for COVID-19 Gains Fast Track Designation
EDP-235 is currently being examined in a first-in-human phase 1 trial to assess safety, tolerability, and pharmacokinetics.
EDP-235 is currently being examined in a first-in-human phase 1 trial to assess safety, tolerability, and pharmacokinetics.
The FDA granted lecanemab Breakthrough Therapy designation back in June, 2021.
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.
None of the products mentioned in the warning letters have been evaluated by the FDA for their intended uses.
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, 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.
Epidiolex® (cannabidiol; GW Pharmaceuticals) oral solution is no longer a controlled substance, according to the Drug Enforcement Administration.
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.
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.
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.