The U.S. Food and Drug Administration approved Merck & Co. Inc.’s combination treatment for complicated forms of urinary tract and abdominal infections.
The return on R&D investment for leading biopharmaceutical manufacturers fell to a nine-year low while the U.S. FDA approved a record-breaking amount of novel medicines during 2018.
The top performers of the launch class of 2016 have very little in common – aside from the fact that none of them came from a “classic” big pharma house.
A U.S. FDA investigator discovered that India’s Strides Pharma Science Ltd. – which exports to the U.S. market – was shredding drug production, quality and laboratory documents.
The FDA approved Gadavist for use in cardiac magnetic resonance imaging to assess myocardial perfusion and late gadolinium enhancement in adults with known or suspected CAD.
The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s diabetes treatment Farxiga for use as a supplement to insulin in adults with a rare type of the condition.
Privately held Azurity Pharmaceuticals won approval for a liquid form of a hypertension drug for both adult and pediatric patients.
Shares of Karyopharm Therapeutics skyrocketed more than 36 percent after the U.S. Food and Drug Administration approved the Newton, Mass.-based company’s Xpovio for treating multiple myeloma.
RedHill Biopharma Ltd. announced that the U.S. Food and Drug Administration accepted for review the New Drug Application for Talicia (RHB-105) for H. pylori infection.
GlaxoSmithKline’s ViiV Healthcare received European Commission approval for Dovato to treat advanced-stage HIV infections in adults and adolescents above the age of 12 and weighing at least 40 kg.
Gilead Sciences announced that a path forward was established to submit a New Drug Application in 2019 for the investigational oral, selective JAK1 inhibitor filgotinib as a rheumatoid arthritis treatment.
The FDA approved San Diego-based Retrophin Inc.’s 100 mg and 300 mg tablets of Thiola EC (tiopronin) to treat cystinuria.