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.

Biohaven Pharmaceutical Holding Co. Ltd. said the U.S. health regulator failed to approve the company’s treatment for amyotrophic lateral sclerosis, or Lou Gehrig’s disease.

The U.S. Food and Drug Administration declined to approve AstraZeneca Plc’s diabetes treatment Farxiga for use as a supplement to insulin in adults with a rare type of the condition.