Kamada has initiated a Phase II clinicaltrial with its proprietary Alpha-1Antitrypsin (AAT) for the prevention oflung transplant rejection.
Sandoz announced the U.S. market introduction of rosuvastatin calcium tablets, a generic version of Crestor by AstraZenica Pharmaceuticals LP.
The U.S. Food and Drug Administration approved bezlotoxumab (Zinplava, Merck) to prevent the recurrence of Clostridium difficile (C. diff) infection (CDI) in patients aged 18years and older.
The U.S. Food and Drug Administration has approved Erelzi (etanercept-szzs), the first biosimilar etanercept, for all indications included in the reference product’s label.
The Department of Health and Human Services awarded nearly $156 million in funding to support 420 health centers in 47 states, the District of Columbia and Puerto Rico to increase access to integrated oral healthcare services and to improve oral health outcomes for Health Center Program patients.
The U.S. Food and Drug Administration has approved Amgen’s Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for the treatment of several autoimmune conditions.
The U.S. Food and Drug Administration has approved Gilead Sciences’ Vemlidy (tenofovir alafenamide,TAF) 25 mg once-daily treatment for adults with chronic hepatitis B virus(HBV) infection with compensated liver disease.
Results from the Phase III PROLONG9FP ongoing extension clinical development program evaluating the long-term efficacy and safety of IDELVION (coagulation factor IX [recombinant], albumin fusion protein) showed that extended prophylaxis treatment regimens effectively prevented bleeds while also reducing overall IDELVION consumption.
A lung cancer vaccine developed in Cuba has been approved by the U.S. Food and Drug Administration for a clinical trial at Roswell Park Cancer Institute in Buffalo, N.Y.
The U.S. Food and Drug Administration granted orphan drug designation to dusquetide (SGX942, Soligenix) for the treatment of macrophage activation syndrome.
The U.S. Food and Drug Administration approved cabozantinib (Cabometyx, Exelixis) to treat advanced renal cell carcinoma (RCC) in patients who have received prior anti-angiogenic therapy.
A randomized Phase III study (ZOE-70) of GlaxoSmithKline’s investigational shingles vaccine, Shingrix, showed 90 percent efficacy in adults aged 70 years and older that is maintained for at least four years.