DUBLIN – Emer Cooke, named this week as the next executive director of the EMA, is the first woman to lead the organization since its creation in 1994. She is due to take up the post in November, but her appointment must first be ratified by the European Parliament’s Committee on the Environment, Public Health and Food Safety (ENVI). She is due to present a statement to the group on July 13.
At a session of the American Association for Cancer Research Virtual Annual Meeting II, multiple FDA regulators gave presentations on various topics to help drug companies understand the ever-evolving oncology regulation.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: EMD Serono, Genprex, Medivir, Merck, Sinovac, Tizona, Viracta.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Fulcrum, GBT, Hemoshear, Imara, Innate, Mayne, Medigene, Neurorx, Novartis, Relief, Philogen.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Immunovative, Mirror Biologics, Karuna, Karyopharm, Marker, Myovant, Novaremed, Pharmacyclics, Polynoma, Reneo, Renibus, Santhera.
Xpovio (selinexor), an oral selective inhibitor of nuclear transport from Karyopharm Therapeutics Inc., of Newton, Mass., received FDA approval today for treating adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. Xpovio will be available immediately in the U.S., the company said, and, due to COVID-19 restrictions, the launch will be a virtual one.
HONG KONG - Mumbai-based Glenmark Pharmaceuticals Ltd. has been granted manufacturing and marketing approval for the launch of its antiviral drug, favipiravir, for the treatment of mild to moderate COVID-19, a move it deems a “landmark development for COVID-19 patients in India.”
RSS
