Positive final results from the Phase III COSMIC-311 trial for Cabometyx (cabozantinib) were reported by Exelixis for patients diagnosed with previously treated radioactive iodine-refractory differentiated thyroid cancer.
FDA Approves First Biologic for SSc-ILD
Adults, Approvals, Autoimmune Diseases, Biologics, Blockbusters, Clinical Trials, FDA, Genentech, Immune System, New Indications, Pulmonary Function, R&D, Rheumatoid Arthritis, Scleroderma, Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD), Therapeutics, VentilatorsThe U.S. Food and Drug Administration approved Genentech’s Actemra (tocilizumab) for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
FDA Approves Trikafta, Symdeko and Kalydeco for CF Patients With Certain Rare Mutations
Approvals, Blockbusters, Children, Cystic Fibrosis, Cystic Fibrosis Transmembrane Conductance Regulator (CFTR), Expanded Approval, FDA, Genetic Diseases, in vitro data, New Indications, Rare Mutations, TherapeuticsThe 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.
Simponi Aria Approved by U.S. FDA for Active Polyarticular Juvenile Idiopathic Arthritis
Active Polyarticular Juvenile Idiopathic Arthritis (pJIA), Active Psoriatic Arthritis (PsA), Approvals, Blockbusters, Expanded Indication, FDA, FDA/Regulatory, IV Infusion, New Indications, Therapeutics, Tumor Necrosis Factor (TNF)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.
FDA approval for Brilinta, EU recommendation for Lynparza
Approvals, Blockbusters, BRCA mutation, Committee for Medicinal Products for Human Use (CHMP), Coronavirus Vaccines, European Medicines Agency, FDA, FDA/Regulatory, Heart Attacks, Metastatic pancreatic cancer, New Indications, Product Pipeline, Shares, StrokesBritain’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.