FDA sign

China-based Hutchmed failed to get the U.S. Food and Drug Administration’s approval for the company’s proposed drug for pancreatic cancer.

Venatorx Pharmaceuticals shared that the company’s Phase III trial on the investigational treatment for complicated urinary tract infections in adults delivered positive outcomes. 

BioNTech announced an expansion of a collaboration with Regeneron Pharmaceuticals to continue advancing mRNA technology and develop the FixVac candidate BNT116 in combination with Regeneron and Sanofi’s shared pharmaceutical product Libtayo (cemiplimab) for non-small cell lung cancer.

Gemini Therapeutics announced Oct. 5 that the company is reducing employee headcount by 20 percent and ceasing some research and non-clinical programs as part of a corporate restructuring effort to focus on a clinical trial for geographic atrophy.

Two experimental cancer drugs, one for ovarian cancer and one for a form of breast cancer, received Fast Track designation from the U.S. Food and Drug Administration, which will speed up the regulatory process for these medications.

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 approved Jazz Pharmaceuticals’ Xywav for idiopathic hypersomnia in adults.

The U.S. Food and Drug Administration rejected Orphazyme’s key drug candidate for Niemann-Pick disease type C (NPC), causing the Denmark-based biopharmaceutical company’s “meme stock” to decline in trading. 

France-based Genfit launched NASHnext, a novel, non-invasive diagnostic test for nonalcoholic steatohepatitis (NASH) powered by the company’s proprietary diagnostic technology, NIS4. The test is offered in the United States through Labcorp.

The U.S. Food and Drug Administration greenlit AstraZeneca’s Farxiga (dapagliflozin) under priority review for the treatment of chronic kidney disease in patients at risk of progression with or without type 2 diabetes.