The U.S. Food and Drug Administration rejected Reata Pharmaceuticals’ New Drug Application for the company’s proposed chronic kidney disease drug, citing a lack of proof of effectiveness.
Amryt Pharma said on February 28 the U.S. Food and Drug Administration declined to approve the company’s drug for the treatment of a group of rare skin diseases called epidermolysis bullosa.
The U.S. drug regulator declined to approve Sesen Bio Inc.’s lead therapy candidate for a type of bladder cancer, the company said on Aug. 13, sending its shares down more than 80 percent.
The U.S. Food and Drug Administration on July 6 declined to approve Provention Bio Inc.’s experimental diabetes drug, citing insufficient data, sending the company’s shares down about 28 percent
The U.S. drug regulator declined to approve a combination of Merck & Co. Inc.’s blockbuster cancer drug Keytruda and Eisai Co. Ltd.’s Lenvima as the first line of treatment in patients with liver cancer.
The U.S. Food and Drug Administration declined to approve Correvio Pharma Corp.’s Brinavess to correct irregular rhythm in the upper chambers of the heart.
The U.S. Food and Drug Administration declined to approve Enzyvant’s regenerative tissue therapy for a rare immunodeficiency disorder and raised concerns about the privately held drug developer’s manufacturing.
The U.S. FDA denied Lexicon Pharmaceuticals Inc.’s appeal against the rejection of the add-on treatment Zynquista for type 1 diabetes, marking the company’s third major setback during 2019.
The U.S. Food and Drug Administration declined to approve Adamis Pharmaceuticals Corp.’s opioid overdose treatment Zimhi, sending the company’s shares plunging 56 percent.
The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s combination therapy to treat smoker’s lung.