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FDA Extends INCY's Application for Opzelura Label Expansion
Incyte INCY announced that the FDA has extended the review period for the supplemental new drug application (sNDA) for ...
Targeted Oncology7d
FDA Approves Label Update But Not Expansion for Talazoparib/Enzalutamide in mCRPC
FDA updates talazoparib and enzalutamide labeling, confirming survival benefits for HRR-mutated mCRPC, while excluding ...
Fierce Pharma10h
FDA investigates patient deaths after treatment with Sarepta's Duchenne gene therapy Elevidys
In one of the first major tests of the new FDA leadership’s regulatory philosophy toward gene therapies for rare diseases, ...
CURE2d
Illuccix is FDA Approved to Guide Radioligand Use in Prostate Cancer
FDA approved to help select patients with metastatic prostate cancer for radioligand therapy before chemotherapy.
Kalkine Media22h
GE HealthCare : FDA Expands Vizamyl Approval To Broaden Alzheimer's Diagnostic Capabilities
GE HealthCare (GEHC) announced that the U.S. Food and Drug Administration has approved an updated label for its positron emission tomography or PET imaging agent Vizamyl (flutemetamol F 18 injection) ...
Pharmabiz13h
Telix Pharmaceuticals’ Illuccix gets US FDA label expansion to add patient selection for radioligand therapy
Telix Pharmaceuticals’ Illuccix gets US FDA label expansion to add patient selection for radioligand therapy: Melbourne, Australia Wednesday, June 25, 2025, 17:00 Hrs [IST] Melb ...
Pharmabiz11d
AbbVie’s Mavyret receives US FDA label expansion approval for treatment of chronic hepatitis C virus
AbbVie’s Mavyret receives US FDA label expansion approval for treatment of chronic hepatitis C virus: North Chicago Saturday, June 14, 2025, 11:00 Hrs [IST] AbbVie announced tha ...
FDA investigates patient deaths after treatment with Sarepta's gene therapy
The U.S. Food and Drug Administration said on Tuesday that it is investigating reports of two deaths due to acute liver ...