Tag Archive for: Complete Response Letter

Amgen announced that the U.S. Food and Drug Administration (FDA) has completed its review of the company’s supplemental New Drug Application seeking full approval of LUMAKRAS® (sotorasib).

The FDA on Monday denied approval of Alnylam Pharmaceuticals’ siRNA therapy Onpattro (patisiran) for the treatment of cardiomyopathy of transthyretin-mediated amyloidosis.

The FDA has rejected Eli Lilly’s investigational antibody lebrikizumab for the treatment of moderate-to-severe atopic dermatitis due to manufacturing problems, the company announced on Monday.

The FDA on Wednesday rejected Outlook Therapeutics’ investigational ophthalmic bevacizumab solution ONS-5010, which the company was proposing as a treatment for wet age-related macular degeneration.

Thursday, the FDA denied Intercept Pharmaceuticals’ application for its obeticholic acid tablets, which the New Jersey biopharma was proposing to treat patients with pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis.

Wednesday, the FDA denied Aldeyra Therapeutics’ application for ADX-2191 (methotrexate injection, USP), which the Massachusetts biotech was proposing to treat the rare eye cancer primary vitreoretinal lymphoma.

Eli Lilly isn’t having a good year in Alzheimer’s disease. Data released Wednesday from the Phase III A4 study showed solanezumab fell short of its primary endpoint, failing to slow cognitive decline in patients with preclinical Alzheimer’s disease. 

The FDA issued complete response letters to Phathom Pharmaceuticals, flagging the presence of N-nitroso-vonoprazan (NVP) impurities detected in the company’s approved Helicobacter pylori drug products, the company announced Thursday.

Ardelyx, Inc. announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) granted the appeal to the Complete Response Letter (CRL) for the New Drug Application (NDA) for XPHOZAH

On Nov.16, the FDA’s Cardiovascular and Renal Drug Advisory Committee will meet to assess the data supporting Ardelyx’s New Drug Application for tenapanor in chronic kidney disease.