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Added 1 day ago Drug news

FDA issues Complete Response Letter for Zynquista to treat type 1 diabetes

The FDA has issued a Complete Response Letter (CRL) regarding the New Drug Application for investigational Zynquista (sotagliflozin)...

Added 1 day ago Drug news

Oral semaglutide compared to Januvia in patients with type 2 diabetes

Oral semaglutide 7 mg and 14 mg demonstrated superior HbA1c and body weight reductions compared to Januvia (sitagliptin 100 mg)...

Added 1 day ago Drug news

FDA issues Complete Response Letter to Recro Pharma relating to IV meloxicam

Recro Pharma, Inc. announced it has received a second Complete Response Letter (CRL) from the FDA Office of Drug Evaluation...

Added 2 days ago Drug news

Phase III extension study Recorlev meets objectives in Cushing’s syndrome

Strongbridge Biopharma announced the top-line findings from the extended evaluation phase of the pivotal Phase III SONICS study of Recorlev...

Added 2 days ago Drug news

Phase III (Clarity AD/Study 301) of BAN 2401 is initiated for early Alzheimer's disease

Eisai Co., Ltd. announced that a global Phase III clinical study (Clarity AD/Study 301) of BAN 2401, an anti-amyloid beta...

Added 2 days ago Drug news

BD issues statement on FDA relating to paclitaxel-coated devices and long term mortality

BD (Becton, Dickinson and Company) issued the following statement related to the recent letter from FDA to health care providers...

Added 3 days ago Drug news

FDA requires partial hold on trials for Venclexta

AbbVie has announced the FDA has placed a partial clinical hold on all clinical trials evaluating venetoclax (Venclexta /Venclyxto) for...