Sanofi Genzyme Gains Health Canada Approval for Cerdelga May 9, 2017 Gaucher disease is a genetic metabolic condition caused by deficient activity of the enzyme glucocerebrosidase. Read More
AstraZeneca’s Imfinzi Wins FDA Accelerated Approval for Previously Treated Patients with Advanced Bladder Cancer May 9, 2017 Imfinzi is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma. Read More
Altor BioScience Gains FDA Fast Track Designation for Bladder Cancer Drug May 8, 2017 ALT-803 is currently being evaluated in a Phase Ib/II clinical trial. Read More
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