KalVista Submits New Drug Application to FDA for Sebetralstat, the First Oral On-demand Treatment for Hereditary Angioedema.

The U.S. Food and Drug Administration (FDA) granted approval for Pretomanid on August 14, 2019.

Update on the CAPItello-290 Phase III study of Truqap combined with chemotherapy for advanced or metastatic triple-negative breast cancer.

The U.S. Food and Drug Administration (FDA) approved Pexidartinib on August 2, 2019.

NMD Pharma Gets FDA IND Approval to Start Phase 2 Study of NMD670 in US for Charcot-Marie-Tooth Disease.

The U.S. Food and Drug Administration (FDA) approved Darolutamide, marketed under the brand name Nubeqa, on July 30, 2019.

Mozart Therapeutics Administers Initial Dose in Phase 1 Clinical Study of MTX-101 for Autoimmune Disease Therapy.

The U.S. Food and Drug Administration (FDA) approved Recarbrio, which is a combination of imipenem, cilastatin, and relebactam, on July 16, 2019.

Zymeworks Receives FDA Approval for ZW171, a New Bispecific Antibody Targeting Mesothelin-related Tumors.

The U.S. Food and Drug Administration (FDA) approved amlodipine, which is marketed under brand names such as Norvasc, Katerzia, and Norliqva, for medical use. This approval was granted on July 8, 2019.

iTeos and GSK Launch Phase 3 GALAXIES Lung-301 Trial, Evaluating Belrestotug and Dostarlimab in Untreated, Inoperable Advanced/Metastatic PD-L1 Positive Non-Small Cell Lung Cancer.

The U.S. Food and Drug Administration (FDA) granted approval for selinexor on an accelerated basis on July 3, 2019.