News | Lab Lexicon

EMA Fast Tracks Review of Daraxonrasib for Metastatic Pancreatic Cancer

EMA's CHMP starts phased review of daraxonrasib, a medicine for metastatic pancreatic cancer, to accelerate assessment for patients with limited treatment options.

Regulatory

Tavneos marketing authorisation revoked due to data integrity concerns

Marketing Authorisation for Tavneos (Avacopan) Recommended for Revocation

CHMP recommends revoking Tavneos' EU marketing authorisation after finding that the pivotal Advocate study data are incorrect and misleading due to GCP breaches.

Regulatory

Casgevy gene therapy approval for young children with sickle cell disease

FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease

FDA issues supplemental approval for Casgevy, the first CRISPR/Cas9 gene therapy, for patients 2 years and older with sickle cell disease or transfusion-dependent beta thalassemia.

Regulatory

Tregzi immunotherapy approval for chronic GVHD prevention

FDA Approves First Treg Cell Therapy to Prevent Chronic GVHD in Blood Cancer

FDA approves Tregzi, the first regulatory T cell-based immunotherapy, to improve chronic graft-versus-host disease-free survival in adults with blood cancers undergoing stem cell transplantation.

Regulatory

Generic baloxavir marboxil tablets packaging

FDA Approves First Single-Dose Generic Treatment for Influenza

FDA approves first generic of Xofluza (baloxavir marboxil), the first single-dose generic treatment for acute uncomplicated influenza and prophylaxis in patients 5 years and older.

Regulatory

FDA Approves Tzield (teplizumab) for Pediatric Stage 3 Type 1 Diabetes

FDA grants accelerated approval to Tzield (teplizumab) to delay decline of insulin production in pediatric patients ages 8–17 with recently diagnosed Stage 3 type 1 diabetes.

Regulatory

Rextovy naloxone hydrochloride nasal spray packaging

FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose

FDA approves Rextovy, another over-the-counter naloxone nasal spray for emergency treatment of opioid overdose, broadening access and consumer options.

Regulatory

Dexcom Stelo Glucose Biosensor System for pediatric OTC use

FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children

FDA clears Dexcom's Stelo Glucose Biosensor System as the first over-the-counter continuous glucose monitor for children ages 2 and older who do not use insulin.

Regulatory