Generics
Celltrion and Teva Announce FDA Approval of Truxima, a Biosimilar to Rituxan, for Three Non-Hodgkin's Lymphoma Indications
6 December 2018 - - The US Food and Drug Administration has approved Truxima (rituximab-abbs), a monoclonal antibody biosimilar to Rituxan (rituximab) for the treatment of adult patients in three indi...
Dr. Reddy's Laboratories Launches Chlorthalidone Tablets, USP in the US Market
30 November 2018 - - Indian pharmaceutical company Dr. Reddy's Laboratories Ltd. (BSE: 500124) (NSE: DRREDDY) (NYSE: RDY) has lauched Chlorthalidone Tablets USP, 25 mg and 50 mg, a therapeutic eq...
Precision BioSciences Receives FDA Authorisation to Initiate Clinical Study of Gene Edited Cancer Immunotherapy
28 November 2018 - - The US Food and Drug Administration has accepted the Investigational New Drug application for PBCAR0191, an allogeneic anti-CD19 CAR T therapy for B-cell acute lymphoblastic leuke...
Dr. Reddy's Laboratories unveils Chlorthalidone Tablets, USP in the US market
28 November 2018 - Pharmaceutical company Dr. Reddy's Laboratories Ltd (NSE:DRREDDY) (NYSE:RDY) Wednesday reported the availability of Chlorthalidone Tablets USP in 25 mg and 50 mg.The company ad...
Perrigo awarded US FDA tentative approval for first to file generic Ultravate Lotion 0.05%
27 November 2018 - Healthcare company Perrigo Company plc (NYSE:PRGO) (TASE:PRGO) reported on Tuesday the receipt of tentative approval from the US Food and Drug Administration for the first to file g...
US Court of Appeals finds in favour of Dr Reddy's Laboratories in buprenorphine and naloxone sublingual film patent case
22 November 2018 - India-based Dr Reddy's Laboratories has received a favourable decision from the US Court of Appeals for the Federal Circuit, which concluded that Indivior had not shown that it...