Spero Therapeutics, Inc. (SPRO)
- Zacks
Spero (SPRO) Application for UTI Drug Gets Priority Review
Spero's (SPRO) NDA for tebipenem HBr oral tablets for complicated urinary tract infections gets Priority Review.
- GlobeNewswire
Spero Therapeutics Announces Lifting of FDA Clinical Trial Hold on SPR720
CAMBRIDGE, Mass., Jan. 04, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on the Phase 2 trial of SPR720, Spero’s investigational oral product candidate being developed for nontuberculous mycobacterial (NTM) disease. “We are very pleased with the FDA’s decision and eager to bring SPR720 back into the clinic,” said Ankit Mahadevia, M.D., Chief Executive Officer of Spero. “Extensive ana
- GlobeNewswire
Spero Therapeutics Announces FDA Acceptance and Priority Review of New Drug Application for Tebipenem HBr for the Treatment of Complicated Urinary Tract Infections including Pyelonephritis
The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of June 27, 2022CAMBRIDGE, Mass., Jan. 03, 2022 (GLOBE NEWSWIRE) -- Spero Therapeutics, Inc. (Nasdaq: SPRO), today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review designation and confirmed the acceptance for substantive review of the New Drug Application (NDA) seeking approval for tebipenem HBr oral tablets for treatment in adult patients with complicated urinary tract infections (c
