regulatory approval

News

Multicoloured letters with AUTISM spelled in the middle

FDA approves leucovorin – but not for autism

The FDA stops short of approving leucovorin for autism, but will its clearance for ultra-rare condition CFD-FOLR1 lead to more off-label prescribing?

News

Incyte breaks new ground in anal cancer with EU approval

Incyte claims EU approval for Zynyz as the first systemic therapy for anal cancer, as J&J gets the nod for wider use of Akeega in prostate cancer.

News

China's clears Pfizer GLP-1 ecnoglutide for weight loss

Pfizer has claimed its first regulatory approval for a GLP-1 agonist in obesity, getting a green light in China for Sciwind-sourced ecnoglutide.

News

J&J's Tecvayli claims third national priority FDA approval

J&J claims the FDA's third national priority voucher approval, advancing a Tecvayli-based regimen for multiple myeloma into the second-line setting.

News

Ascendis scores FDA approval for weekly dwarfism drug

Children with achondroplasia will soon have the option of a once-weekly - rather than daily - injection, courtesy of Ascendis' newly approved Yuviwel.

News

Hernexeos box, two pills, and pill bottle

Boehringer gets FDA's second 'national priority' approval

Boehringer Ingelheim's lung cancer drug Hernexeos has become the second medicine approved after an FDA national priority review.

FDA approves leucovorin – but not for autism

Incyte breaks new ground in anal cancer with EU approval

China's clears Pfizer GLP-1 ecnoglutide for weight loss

J&J's Tecvayli claims third national priority FDA approval

Ascendis scores FDA approval for weekly dwarfism drug

Boehringer gets FDA's second 'national priority' approval

Remepy's hybrid Parkinson's therapy poised for phase 3

Discover a new era of healthcare panel engagement: Grounded ...

regulatory approval

Editor's Picks