Browsing Tag
US FDA
379 posts
FDA grants approval to Yescarta for treatment of certain types of lymphoma
In a significant development for lymphoma treatment, Kite Pharma, a subsidiary of Gilead Sciences, has received approval from…
October 19, 2017
AstraZeneca’s Tagrisso secures FDA breakthrough therapy designation for first-line treatment of NSCLC
AstraZeneca has achieved a significant milestone with its lung cancer drug, Tagrisso (osimertinib), which has recently been granted…
October 15, 2017
Spark Therapeutics’ Luxturna nears FDA approval for gene therapy treating inherited blindness
In a significant development in gene therapy, Spark Therapeutics’ Luxturna (voretigene neparvovec) is on the verge of receiving…
October 15, 2017
Novo Nordisk’s Fiasp gains FDA approval for fast-acting insulin, enhancing diabetes management in US
Novo Nordisk, a leading Danish pharmaceutical company, has secured a significant regulatory milestone with the US FDA approval…
October 2, 2017
FDA approves Eli Lilly’s Verzenio for metastatic breast cancer treatment
Eli Lilly and Company (Lilly) has announced receiving U.S. Food and Drug Administration (FDA) approval for Verzenio (abemaciclib),…
September 30, 2017
FDA approves Novo Nordisk’s Victoza for heart disease treatment in type 2 diabetes patients
In a significant advancement for diabetes care, Danish pharmaceutical giant Novo Nordisk has received approval from the U.S.…
August 26, 2017
FDA approves Genentech’s lucentis for comprehensive diabetic retinopathy treatment
Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA)…
April 23, 2017
India’s CDSCO grants APAC Biotech license for immuno-oncology drug Apceden
The Central Drugs Standard Control Organization (CDSCO), India’s regulatory authority, has granted a commercial license to APAC Biotech…
April 16, 2017
Pfizer’s inotuzumab ozogamicin gains FDA priority review in acute lymphoblastic leukemia
Pfizer Inc. has received a priority review designation from the U.S. Food and Drug Administration (FDA) for its…
February 23, 2017