The U.S. Food and Drug Administration approved Vertex Pharmaceuticals Inc.’s Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor), Symdeko (tezacaftor/ivacaftor and ivacaftor) and Kalydeco (ivacaftor) for use in people with cystic fibrosis with certain rare mutations.
The U.S. Food and Drug Administration approved Janssen’s Simponi Aria (golimumab) for patients 2 years of age and older for the treatment of active polyarticular juvenile idiopathic arthritis (pJIA) and extended the medicine’s active psoriatic arthritis (PsA) indication for this same patient population.
The U.S. Food and Drug Administration granted marketing clearance for Janssen Pharmaceutical’s Tremfya as a treatment for active psoriatic arthritis, marking the first time a selective interleukin (IL)-23 inhibitor was approved as a treatment for the chronic progressive disease.
Britain’s AstraZeneca clinched expanded regulatory backing for two medications, including one for the blockbuster cancer treatment Lynparza, in a development pipeline that now includes a possible coronavirus vaccine.
The FDA greenlit the combination therapy along with limited chemotherapy for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations.
The U.S. Food and Drug Administration approved Merck’s Dificid (fidaxomicin) for a new oral suspension as well as for the treatment of Clostridioides difficile-associated diarrhea (CDAD) in children ages 6 months and older.
The U.S. Food and Drug Administration approved Pfizer Inc.’s Xeljanz XR (tofacitinib) extended-release 11 mg and 22 mg tablets for the once-daily treatment of adult patients with moderately to severely active ulcerative colitis, after an inadequate response or intolerance to TNF blockers.
The U.S. Food and Drug Administration approved Janssen’s Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant.
Merck & Co. reported that the checkpoint inhibitor Keytruda had mixed results as a first-line treatment of advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma.