The U.S. Food and Drug Administration approved expanded use of Vertex Pharmaceuticals Inc.’s Trikafta to treat cystic fibrosis in children aged 6 to 11 years old, making the cocktail therapy the first approved treatment for CF in that age group.
The U.S. Food and Drug Administration extended the review period for expanded use of Abbvie Inc.’s rheumatoid arthritis drug Rinvoq by three months, citing the need for more time to assess the drug’s benefit-risk profile.
The U.S. Food and Drug Administration cleared expanded use of GlaxoSmithKline Plc’s Zejula as a first option to keep advanced ovarian cancer at bay in women who have responded to chemotherapy.
The U.S. Food and Drug Administration approved the expanded use of Adacel to include repeat vaccination to help protect against tetanus, diphtheria and pertussis.
The U.S. FDA approved an expanded label for Merck’s anti-PD-1 therapy Keytruda in combination with Alimta (pemetrexed) and platinum chemotherapy for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer, with no EGFR or ALK genomic tumor aberrations, based on results of the KEYNOTE-189 trial.
U.S. health regulators expanded the use of Vertex Pharmaceuticals Inc.’s cystic fibrosis drug Kalydeco to include patients aged between 12 months and 24 months.
U.S. regulators expanded use of AstraZeneca’s lung cancer drug Tagrisso to include initial treatment of patients with a specific genetic mutation.
The U.S. Food and Drug Administration approved expanded use of AstraZeneca Plc’s cancer drug Lynparza.
The U.S. FDA approved the use of Pfizer Inc.’s cancer drug Sutent to help prevent kidney cancer from returning following surgical removal of a kidney.
The FDA expanded the use of Lynparza, sold by AstraZeneca Plc and Merck & Co. Inc., and approved a new two-tablet regimen for the drug.