Dr. Reddy’s launches Toripalimab in India, the first and only immuno-oncology drug approved for the treatment of nasopharyngeal carcinoma

Proud to announce the launch of Toripalimab in India, the first and only immuno-oncology drug approved by various regulatory authorities around the world such as the USFDA, DCGI, EMA, MHRA and others for the treatment of adults with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). Toripalimab is a New Biological Entity (NBE). The combination of Toripalimab … Read more

Amneal Resubmits DHE Autoinjector New Drug Application and Receives U.S. FDA Approval of Exenatide

Potential first and only DHE autoinjector for tough-to-treat migraines and cluster headaches Exenatide approval highlights Amneal’s capabilities in developing GLP-1 injectables BRIDGEWATER, N.J.–(BUSINESS WIRE)– Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company, today announced the advancement of two key strategic initiatives. First, the Company has resubmitted to the U.S. Food and … Read more

Ultromics’ breakthrough device for cardiac amyloidosis gets FDA nod

EchoGo® Amyloidosis is an AI-based software-only medical device, which aims to improve early detection of Cardiac Amyloidosis, an underdiagnosed cause of heart failure. EchoGo® Amyloidosis sits on Ultromics’ EchoGo® platform complementing the existing commercialized EchoGo® Heart Failure device. Ultromics’ EchoGo® Amyloidosis, clinical AI for echocardiography with the potential to revolutionize early detection of Cardiac Amyloidosis, … Read more

Cefepime – Enmetazobactam Antibiotic Launch | Orchid Pharma & Cipla Partnership

Orchid Pharma Limited, (‘Orchid Pharma’) based in Chennai, India, the only Indian pharmaceutical company to have ever invented a New Chemical Entity (NCE), announced the launch of its new drug – Cefepime-Enmetazobactam, which has been approved for the treatment of complicated Urinary Tract infections (cUTI), Hospital-Acquired Pneumonia (HAP) and Ventilator-Associated Pneumonia (VAP) indications. In a … Read more

Indoco Remedies receives final ANDA approval from USFDA for Varenicline Tablets, 0.5 mg and 1 mg

Indoco Remedies Ltd. announced the final approval of the Company’s Abbreviated NewDrug Application (ANDA) for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent to the reference listed drug (RLD), Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF) from USFDA.Varenicline Tablets, 0.5 mg and 1 mg bioequivalent and … Read more

Exit mobile version