FDA Requests Long-Term Safety Info for Intra-Cellular’s Schizophrenia Drug May 8, 2017 The company revealed positive topline results from a Phase III lumateperone trial last September. Read More
April Sees 66 ANDA Approvals and 112 CRLs May 5, 2017 The FDA received 75 ANDAs in April, a steep drop from the 197 received in the previous month. Read More
European Commission Approves Bristol-Myers Squibb’s Opdivo May 5, 2017 Opdivo uses the body’s immune system to help restore anti-tumor immune response. Read More
FDA Gives Nod to Radius Health’s Osteoporosis Drug Tymlos May 5, 2017 The drug has also been shown to increase bone mineral density. Read More
FDA Approves Combination Treatment for Acute Myeloid Leukemia May 4, 2017 The drug is approved for use with a companion diagnostic. Read More
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