FDA Grants Accelerated Approval to Takeda’s Alunbrig May 4, 2017 Alunbrig, is a once-daily oral therapy. Read More
FDA Warns Drugmaker for Inaccurate API Listing May 3, 2017 The listing included Ferrous Cation as an ingredient. Read More
China FDA Approves Combination Treatment for Chronic Hepatitis C May 3, 2017 Daklinza has been approved in China for combination use with other agents. Read More
Novo Nordisk Receives FDA Approval of Saxenda Label Update May 2, 2017 The updated label includes clinical trial data supporting the safety and efficacy of the drug over a 3-year term. Read More
FDA Approves BioMarin's Brineura May 2, 2017 BioMarin also received a rare pediatric disease priority review voucher. Read More
Inspirion Delivery Sciences Receives FDA Approval for RoxyBond tablets CII May 1, 2017 The drug is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse. Read More
EU Grants Shire Conditional Marketing Authorization for Natpar May 1, 2017 The drug was developed as a hormone therapy indicated as an adjunctive treatment for adult patients with chronic hypoparathyroidism. Read More
Health Canada Mandates eCTD Format for New Drug Submissions Starting January 2018 April 28, 2017 Exemption from the requirement will be considered on a case by case basis. Read More
European Commission Clears AstraZeneca’s Tagrisso for Marketing April 28, 2017 The FDA granted Tagrisso approval in March. Read More
FDA Expands Approval Sanofi’s Thymoglobulin for the Prevention of Kidney Transplant Rejection April 27, 2017 Clinical studies revealed a composite endpoint rate within 12 months post transplantation of 25.1 percent. Read More
FDA Expands Approval Sanofi’s Thymoglobulin for the Prevention of Kidney Transplant Rejection April 25, 2017 Two clinical studies showed significantly lower incidence of treatment failure. Read More
Laurent Pharmaceuticals Wins FDA and Health Canada Clearance for Phase 2 Clinical Study of LAU-7b April 25, 2017 The study will enroll about 136 adults with CF for a 6-month treatment. Read More