Approvals
Retrophin, based in San Diego, announced that the U.S. Food and Drug Administration (FDA) had given its 100 mg and 300 mg tablets of Thiola EC (tiopronin) the thumbs-up to treat cystinuria.
Exiting the last week of June and heading into July, a number of companies announced results from ongoing clinical trials. Here’s a look.
Darzalex in combination with lenalidomide and dexamethasone was approved as a first-line treatment for multiple myeloma patients who are ineligible for autologous stem cell transplant.
The U.S. Food and Drug Administration (FDA) gave Alexion Pharmaceuticals a thumbs-up for Soliris (eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) in adults that express a specific biomarker.
Clinical data showed Dupixent reduces nasal polyp size, improves congestion and loss of smell, while reducing the need for surgery and systemic corticosteroids.
The Complete Response Letter indicated the company will need to run an “adequate and well-controlled trial to determine whether celiprolol reduces the risk of clinical events in patients with vEDS.”
July looks to be a quiet month for the U.S. Food and Drug Administration (FDA), and it sure looks like the agency is trying to get a lot of work done before the July 4 holiday. Here’s a look at the many approvals scheduled for this week.
Allergan announced that the U.S. Food and Drug Administration has approved its wrinkle treatment Botox for children with upper limb spasticity. The news comes just days after rumors that the company may break up.
The approval marks the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes.
June is turning out to be a busy month for approvals for the U.S. Food and Drug Administration. The agency has a slate of PDUFA dates this week, including two for Merck alone. Here’s a look.
PRESS RELEASES