SPOTLIGHT -
In an interview with Pharmaceutical Executive associate editor Don Tracy, Ashley Gaines, VP, head of breast cancer franchise, discusses newly approved Truqap.
FDA Grants Breakthrough Therapy Designation to Gilead’s Trodelvy for Extensive-Stage Small Cell Lung Cancer
Breakthrough Therapy designation for Trodelvy was granted based on promising results from the Phase II TROPiCS-03 study, which showed encouraging antitumor activity in both platinum-resistant and platinum-sensitive extensive-stage small cell lung cancer.
FDA Approves Celltrion’s Stelara Biosimilar for Multiple Indications
Approval of Steqeyma was based on a comprehensive evidence review, including a Phase III trial in moderate to severe plaque psoriasis.
Merck, Johnson & Johnson Submit Biologics License Applications for Pediatric Respiratory Syncytial Virus, Ulcerative Colitis
New biologics license applications seek FDA approval for Merck’s clesrovimab to protect infants and children from respiratory syncytial virus and Johnson & Johnson’s Simponi for the treatment of ulcerative colitis.
FDA Approves Organon’s Vtama Cream, 1% for Atopic Dermatitis
Approval of Vtama for atopic dermatitis provides a steroid-free treatment option for adults and pediatric patients.
FDA Grants Breakthrough Therapy Designation to GSK’s Jemperli for Locally Advanced Mismatch Repair Deficient/Microsatellite Instability-High Rectal Cancer
The Breakthrough Therapy Designation for Jemperli was based on Phase II clinical trial data, showing a 100% clinical complete response rate in patients with locally advanced mismatch repair deficient/microsatellite instability-high rectal cancer.
A Rocky Road for Regulation
With the Inflation Reduction Act now in flux, how will the government and industry respond?