U.S. hospital products maker Baxter International Inc. forecast a nearly $70 million hit to its fourth-quarter 2017 revenue, due to manufacturing disruptions arising from Hurricane Maria.
The U.S. Food and Drug Administration issued a warning letter to Meridian Bioscience Inc.’s unit for several federal law violations after inspecting its facility that makes lead-testing devices.
Novartis said the U.S. Food and Drug Administration granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery.
The head of the U.S. Food and Drug Administration said the agency was working with several pharmaceutical and medical device companies in Puerto Rico to prevent shortages of medical products in the United States as it joins a massive effort to help rebuild the island that was ravaged by Hurricane Maria.
Two months after slashing 28 percent of its workforce as part of a strategic review, Ardelyx Inc. announced positive Phase III results for tenapanor, its irritable bowel syndrome with constipation (IBS-C).
Trevena Inc. is banking its future on possible approval of troubled pain medication Olinvo eight months after Phase III data raised some questions over the drug’s safety profile.
Aerie Pharmaceuticals Inc.’s experimental glaucoma treatment Rhopressa is effective in lowering eye pressure, a preliminary review by the U.S. Food and Drug Administration concluded.
Philips is suspending the manufacture of some defibrillators in the United States and will make others under heightened scrutiny following criticisms from U.S. regulators, in a move the health technology company said would dent profits.
Spark Therapeutics Inc.’s experimental gene therapy for a rare inherited form of blindness improves vision, though it is unclear whether the benefit lasts over time, according to a preliminary review by the U.S. Food and Drug Administration.
AstraZeneca today announced that the US Food and Drug Administration granted Breakthrough Therapy Designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.