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Concerns regarding hypoglycemia potentially linked to a counterfeit version of Ozempic come at a time in which reports have grown regarding the improper use of GLP-1 receptor agonists for the purpose of cosmetic weight loss.

Adverse Event Reports Linked to Counterfeit Ozempic on the Rise

Dupixent is now the first and only treatment option for eosinophilic esophagitis in patients aged 1 and older, weighing at least 15 kg.

Dupixent Approved for Expanded Indication in Children Under 12 Years With Eosinophilic Esophagitis 

As technology continues to advance, investigators explore the legal protocol for how to handle AI-responsible injuries.

Examining the Liability Risk Surrounding Artificial Intelligence Tools in the Healthcare Environment 

Zynrelef was initially approved by the FDA for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours following bunionectomy, open inguinal herniorrhaphy, and total knee arthroplasty.

Indication for Zynrelef Expanded to Include Orthopedic, Soft Tissue Procedures

Tesamorelin (Egrifta) was initially approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.

sBLA for New Formulation of Tesamorelin Issued Complete Response Letter by FDA

FDA adds Boxed Warning that the osteoporosis medication increases the risk for severe hypocalcemia in patients with advanced chronic kidney disease, especially among those undergoing dialysis

FDA Warns Against Risk of Hypocalcemia in Patients With Kidney Disease Taking Prolia 

Patients treated with Tremfya (guselkumab) saw major improvements in scalp psoriasis clearance, itch reduction, and patient-reported health-related quality of life.

Tremfya Produces Significant Improvements in Scalp Psoriasis in People of Color

Treatments required to have updated warnings include all FDA-approved CAR T-cell therapies and licensed BCMA-directed and CD19-directed genetically modified autologous CAR T-cell immunotherapies. 

FDA to Require Boxed Warning Labels on CAR T-Cell Therapies for Secondary Cancer Risks

The FDA assigned Autolus Therapeutics' biologics license application for obecabtagene autoleucel with a Prescription Drug User Fee Act date of November 16, 2024.

FDA to Evaluate BLA for Obe-Cel to Treat B-Cell Acute Lymphoblastic Leukemia 

The definitive merger agreement was reached in October 2023, with Bristol Myers Squibb acquiring Mirati for $58 per share in cash, for a total equity value of $4.8 billion.

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