Tag Archive for: Fast-Track Designation

The Neisseria gonorrhoeae investigational vaccine is currently at a mid-stage trial and aims to demonstrate efficacy of the vaccine in healthy adults who are at high risk of the infection.

It was a good Thursday for GSK’s Jemperli (dostarlimab), as the immunotherapy received both full FDA approval in endometrial cancer and the regulatory go-ahead regarding its development plan in rectal cancer. 

Kintara Therapeutics Inc., a biopharmaceutical company focused on the development of new solid tumor cancer therapies, announced that the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to Kintara’s REM-001 Therapy for the treatment of patients with cutaneous metastatic breast cancer (CMBC).

Mereo BioPharma will cut 40% of its headcount and significantly reduce expenses to support the advancements of its lead programs through the clinic, the company announced Tuesday. 

Eli Lilly and Co. said on Thursday the U.S. Food and Drug Administration (FDA) had agreed to a quick review of its diabetes drug Mounjaro to treat obesity, months after a study showed it helped people lose more than 20% of their weight.

The FDA approved Mallinckrodt Pharmaceuticals’ Terlivaz (terlipressin) in adults with hepatorenal syndrome (HRS), making it the only FDA-approved drug for that indication in the U.S.

Inhibrx Inc. announced that the European Commission (“EC”), based on a positive opinion issued by the European Medicines Agency (“EMA”), has granted orphan medicinal product designation to INBRX-109 for the treatment of chondrosarcoma.

Shares of Akero Therapeutics were surging Thursday after the company announced that pharma giant Pfizer made a $25 million equity investment that will help support the development of its experimental pre-cirrhotic and cirrhotic nonalcoholic steatohepatitis therapeutic (NASH) drug. 

The U.S. Food and Drug Administration (FDA) is on a mission to recover from the review lag seen through the early years of COVID-19 and has issued special designations for two treatments that could improve the lives of millions diagnosed with recurrent glioblastoma or hemophilia.

RhoVac AB announced Tuesday that the company’s prostate cancer drug candidate failed to meet targets in a Phase IIb study.