The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.
The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).
The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).
The Food and Drug Administration (FDA) has granted Fast Track status to ARA290 (Araim Pharmaceuticals) for the treatment of Sarcoidosis-associated Small Fiber Neuropathy (SFN).
The FDA has granted Orphan Drug designation to AC-201 for the treatment of epidermolysis bullosa (EB).
The FDA has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, a once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.
The FDA has accepted for filing the NDA for empagliflozin plus immediate-release metformin HCl fixed-dose combination for the treatment of adults with type 2 diabetes.
The FDA has accepted for review the Supplemental New Drug Application (sNDA) for Fycompa (perampanel; Eisai) for the treatment of primary generalized tonic-clonic (PGTC) seizures.
The FDA has granted Fast Track designation for trifluridine and tipiracil hydrochloride (TAS-102), an oral combination anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).
Regeneron announced results from an effectiveness study sponsored by the National Institutes of Health (NIH) in patients with diabetic macular edema (DME) treated with Eylea (aflibercept) Injection compared to Avastin (bevacizumab; Genentech) and Lucentis (ranibizumab; Genentech).