The U.S. Food and Drug Administration (FDA) approved Avapritinib on January 9, 2020, for the treatment of unresectable or metastatic gastrointestinal stromal tumors (GIST) harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations.

Takeda has revealed that the European Commission has given its approval for FRUZAQLA (fruquintinib) to be used as a monotherapy for adult patients suffering from metastatic colorectal cancer.

The U.S. Food and Drug Administration (FDA) approved Ubrogepant on December 23, 2019.

Bristol Myers Squibb reveals that the U.S. FDA has granted accelerated approval for KRAZATI® (adagrasib) combined with Cetuximab for adults with previously treated, advanced, or metastatic colorectal cancer (CRC) with the KRAS G12C mutation.

The U.S. Food and Drug Administration (FDA) first approved Enhertu on December 20, 2019, for the treatment of HER2-positive breast cancer.

Jun 27th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.

The U.S. Food and Drug Administration (FDA) approved Caplyta on December 20, 2019, for the treatment of schizophrenia in adults.

Zealand Pharma reveals favorable topline outcomes from the 16-week Phase 1b trial with escalating doses of long-acting amylin analog petrelintide.

The U.S. Food and Drug Administration (FDA) approved Dayvigo on December 20, 2019, for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance in adults.

Kyverna's KYV-101 gets U.S. FDA IND approval for treating patients with hard-to-treat Stiff-Person Syndrome in the KYSA-8 Phase 2 study.

The U.S. Food and Drug Administration (FDA) granted approval to Padcev on December 18, 2019, for the treatment of adults with locally advanced or metastatic urothelial cancer, a common type of bladder cancer.

Jun 26th latest updates in the global new drug development field, including progress in new drug research and development, transaction information, and partnership developments.