BI’s OFEV Approved in Europe for Interstitial Lung Disease April 22, 2020 The FDA approved the drug for systemic sclerosis-associated interstitial lung disease in September 2019. Read More
Surufatinib Earns Fast-Track Designation April 21, 2020 The drug received an Orphan Drug designation in November 2019. Read More
FDA Approves Incyte’s Pemazyre for Rare Cancer April 21, 2020 Incyte must conduct a randomized clinical trial demonstrating an improvement in progression-free survival or overall survival. Read More
FDA Gives Regeneron’s Ebola Treatment Priority Review April 20, 2020 The FDA decision date on the drug is Oct. 25. Read More
FDA Approves UroGen Pharma’s Jelmyto for Urothelial Cancer April 17, 2020 The drug received priority review, breakthrough therapy, fast-track and orphan drug designations. Read More
Merck Launches Herceptin Biosimilar Ontruzant April 16, 2020 The FDA approved Ontruzant in January 2019. Read More
Immunomic Teams Up With PharmaJet and EpiVax on COVID-19 Vaccine April 15, 2020 Immunomic previously developed a vaccine candidate for Severe Acute Respiratory Syndrome (SARS). Read More
Koselugo Approved for Children with Neurofibromatosis Type 1 April 14, 2020 The drug received a priority review and breakthrough-therapy designations. Read More
FDA Clears First Generic Proventil Inhaler April 13, 2020 Commissioner Stephen Hahn said the agency recognizes the increased demand for albuterol products during the pandemic. Read More
Takeda’s Alunbrig Receives Expanded EU Approval for Lung Cancer April 9, 2020 The FDA granted Alunbrig accelerated approval in April 2017. Read More
Roche Reports Delay in FDA’s Review of SMA Drug Risdiplam April 9, 2020 The FDA’s review of Roche’s experimental spinal muscular atrophy (SMA) drug risdiplam has been delayed, the company said. Read More
Novo Nordisk’s Rybelsus Nabs European Approval April 7, 2020 Novo Nordisk expects to launch Rybelsus in the second half of 2020. Read More