FDA Approves Biohaven’s Nurtec for Acute Treatment of Migraines March 9, 2020 Nurtec ODT is the company’s first FDA-approved product. Read More
CHMP Recommends Approval of Two Antibiotics, Including One Generic March 9, 2020 The committee shot down an extended indication for Eli Lilly’s Emgality for prevention of episodic cluster headaches. Read More
Vizient Links FDA’s Unapproved Drugs Initiative to Higher Drug Costs March 6, 2020 The FDA said that it is “keenly aware of price fluctuations that can occur on the heels of its regulatory actions.” Read More
Advisory Committee Votes in Favor of Eli Lilly’s Monoclonal Antibody March 5, 2020 Cyramza showed an improvement in progression-free survival, the FDA said. Read More
NICE Turns Down Roche’s Polivy for Lymphoma Combination March 5, 2020 Polivy received EU clearance in January for patients with previously treated aggressive lymphoma. Read More
FDA Approves Nerlynx-Capecitabine Combination for Breast Cancer March 5, 2020 The drug is also approved for treatment of adults with early stage HER2-positive breast cancer. Read More
FDA Approves First Generic of ProAir HFA March 4, 2020 The agency wants to expand opportunities to bring generic copies of complex drugs to market. Read More
Sanofi to Create New API Company March 4, 2020 Sanofi is spinning off six of its manufacturing facilities for the new company, but it will retain a 30 percent stake. Read More
Esperion’s Nexletol Approved for Lowering Cholesterol March 3, 2020 The approval was supported by positive results from a phase 3 study in more than 3,000 patients. Read More
FDA Approves Lundbeck’s Vyepti for Prevention of Migraine March 3, 2020 Vyepti is the first intravenous preventative treatment for migraine. Read More
Eli Lilly’s Trulicity Approved for Reducing Cardiovascular Events March 3, 2020 Trulicity was originally approved in 2014 to improve blood sugar in adults with type 2 diabetes. Read More
Japan Approves Opdivo for Unresectable Advanced or Recurrent Esophageal Cancer March 2, 2020 Opdivo has thirteen approved indications in the U.S. Read More