News and information on branded drugs sold in retail pharmacies, as well as their suppliers.
Merck has received the FDA's blessing for a pediatric indication for Dificid, as well as an oral suspension formulation.
The FDA has approved Trijardy, the only triple-combination tablet with Jardiance for adults with Type 2 diabetes.
Tazverik offers the first treatment option for patients with a rare soft tissue cancer.
Merck’s acquisition of ArQule diversifies its oncology pipeline.
The earliest licensed entry of any generic linaclotide 145 mcg or 290 mcg Linzess is March 2029.
Valtoco is the first nasal spray approved by the Food and Drug Administration as a rescue treatment for people with epilepsy age 6 years old and older.
Hikma and Arecor's new product uses Arecor’s drug formulation technology platform Arestat.
Tepezza is the first approved treatment for thyroid eye disease.
The list price for Lill's Humalog Mix75/25 KwikPen and Humalog Junior KwikPen will be 50% less than branded versions.
Intra-Cellular plans to launch Caplyta in the first quarter of this year.
Lannett expects to launch Numbrino nasal solution shortly.
Warner Chilcott and Watson subsidiaries will pay approximately $300 million under settlement agreements.
Twenty-nine of the 48 novel drug approvals of 2019, or 60%, were designated in one or more expedited categories of Fast Track, Breakthrough, Priority Review, and/or Accelerated Approval.
Vascepa was originally approved as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.