It was reported yesterday that the US Food and Drug Administration (USFDA) has granted breakthrough therapy designation to United States-based Celgene's Pomalyst (pomalidomide) intended for the treatment of HIV.
The designation has been granted for the product to treat patients with HIV-positive Kaposi sarcoma who have earlier received systemic chemotherapy, in addition to patients with HIV-negative Kaposi's sarcoma.
Pomalyst is one of the firm's IMiD agents for the treatment of some blood cancers. It is a thalidomide analogue indicated, in combination with dexamethasone, to treat patients with multiple myeloma who have received at least two prior therapies including lenalidomide and proteasome inhibitor.
Clene Inc closes registered direct offering of common stock to existing shareholders
Insmed's ARIKAYCE sNDA granted priority review by FDA
Precigen announces FDA platform technology designation for AdenoVerse
Enhertu recommended for EU approval in early HER2-positive breast cancer
PureTech receives FDA Fast Track designation for LYT-200 in HR-MDS
MaaT Pharma outlines potential Phase 3 development plan for MaaT013 after CHMP negative opinion
Bayer's Kerendia wins FDA approval for chronic kidney disease associated with type 1 diabetes
Myosin Therapeutics chosen for 2026-2027 NCI Investor Initiatives Showcase
Medtronic receives FDA clearance for LigaSure RAS Maryland instrument on Hugo system
VaxThera partners with Codagenix for next generation yellow fever vaccine advancement
MaaT Pharma receives negative CHMP trend vote for MaaT013
FDA approves Scholar Rock's ISEMBYLD to treat spinal muscular atrophy
FDA grants priority review to Takeda's zasocitinib application for plaque psoriasis