Feb. 12, 2018, is the day the U.S. FDA is expected to review Gilead Sciences’ HIV treatment that some analysts suggest could become a blockbuster.

Specialty pharmaceutical company Mallinckrodt plc struck a deal to acquire privately held InfaCare, a Pennsylvania-based company focused on therapies for neonatal and pediatric patients.

Just like 2016 and the year before, specialty drugs dominate the 2017 list of top performers in the most recent first year after launch class.

The European Medicines Agency (EMA), eager to accelerate access to promising new drugs, may be getting too cozy with the pharmaceutical companies it regulates.

Pfizer Inc. announced that the supplemental New Drug Application for Xeljanz (tofacitinib citrate), an investigational oral treatment for adult patients with moderately to severely active ulcerative colitis, has been accepted for filing by the U.S. Food and Drug Administration.

Glenmark Pharmaceuticals is in the middle of a strategic transformation that company officials believe will build off its revenues from a proven generics business to fund a pipeline of homegrown branded medicines.

Puma Biotechnology shares plummeted after the company disclosed patients taking its experimental breast cancer drug neratinib may require a second drug to prevent serious diarrhea.

Dallas/Fort Worth, Texas-based Neos Therapeutics announced yesterday that the U.S. Food and Drug Administration (FDA) had found deficiencies in its New Drug Application (NDA) for Cotempla XR-ODT to treat attention deficit hyperactivity disorder (ADHD). As a result, they would not be discussing labeling and postmarketing requirements until further review.   Neos focuses on developing and […]

* Amicus unlikely to file application this year * Had earlier expected to file application by Q4 * Drug aims to be first oral drug for Fabry disease * Company says European filing on track * Stock slumps as much as 59 pct (Adds details)   By Natalie Grover Oct 2 (Reuters) – Amicus Therapeutics […]

European pharmaceuticals group Sanofi on Tuesday said its application for review for its new drug, lixisenatide, a diabetes treatment, had been accepted by the U.S. Food and Drug Administration.   (Reporting by Astrid Wendlandt) Source: Reuters Health