Browsing Tag
FDA approval
131 posts
Roche to strengthen gene therapy portfolio with Spark Therapeutics acquisition
Swiss pharmaceutical giant Roche has reached a major agreement to acquire the U.S.-based gene therapy company Spark Therapeutics…
March 31, 2019
Roche’s Tecentriq secures FDA approval for small cell lung cancer treatment
Roche’s subsidiary, Genentech, has announced a significant breakthrough with the US Food and Drug Administration (FDA) approval of…
March 30, 2019
Biotronik secures FDA approval for cutting-edge heart rhythm management devices
Biotronik, a German biomedical technology company, has received approval from the US Food and Drug Administration (FDA) for…
March 16, 2019
FDA greenlights Amgen’s Nplate for pediatric immune thrombocytopenia
Amgen’s Nplate (romiplostim) has received US Food and Drug Administration (FDA) approval for treating pediatric patients with immune…
December 16, 2018
Seattle Genetics’ Adcetris receives FDA approval for peripheral T-cell lymphoma
Seattle Genetics’ Adcetris, in combination with CHP chemotherapy, gains FDA approval for treating certain types of peripheral T-cell…
November 18, 2018
Cosmo Technologies secures FDA approval for Aemcolo to treat travelers’ diarrhea
Cosmo Technologies has achieved a significant milestone with the recent approval from the U.S. Food and Drug Administration…
November 18, 2018
Pfizer’s Lorbrena receives FDA approval for advanced lung cancer treatment
Pfizer Inc., a leading US pharmaceutical company, has secured approval from the US Food and Drug Administration (FDA)…
November 3, 2018
Dupixent receives FDA approval for treatment of moderate-to-severe asthma
Sanofi and Regeneron Pharmaceuticals’ Dupixent (dupilumab) has achieved a significant milestone with the U.S. Food and Drug Administration…
October 21, 2018
AstraZeneca secures FDA approval for Lumoxiti in hairy cell leukemia treatment
AstraZeneca has achieved a major regulatory milestone with the US Food and Drug Administration (FDA) approval of Lumoxiti…
September 14, 2018
Bayer secures FDA approval for hemophilia A treatment drug Jivi
In a major advancement for hemophilia A therapy, Bayer’s recombinant factor VIII (rFVIII) replacement therapy, Jivi (BAY94-9027), has…
September 1, 2018