The Latest Breaking News from FDA

Recently, Vir Biotechnology Inc (NASDAQ:VIR) announced updates on its expansive hepatitis portfolio, including VIR-2218 which is part of a collaboration with Alnylam Pharmaceuticals Inc (NASDAQ:ALNY), and VIR-3434, a monoclonal antibody (mAb).  The key highlight of the event was the initial data presented from the Phase 2 MARCH trial of VIR-2218 + VIR-3434 in patients with…

Moderna Inc's (NASDAQ:MRNA) chief medical officer said that its COVID-19 vaccine for children under six years old would be ready for review by the FDA panel when it meets in June. "I think the FDA now has all of the core fundamental data they need to be able to begin an application review.…

The FDA has instituted a clinical hold on Vertex Pharmaceuticals Incorporated's (NASDAQ:VRTX) VX-880 Phase 1/2 study due to a determination that there is insufficient information to support dose escalation with the product. VX-880 is an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for type 1 diabetes (T1D).  Three patients have been…

Kala Pharmaceuticals Inc (NASDAQ:KALA) reported data from a Phase 1b trial of KPI-012, a cell-free secretome therapy for severe ocular diseases driven by impaired healing.  As previously disclosed, KPI-012 was well tolerated and resulted in significant improvements in various persistent corneal epithelial defect (PCED) etiologies.  The data will be presented at the 2022…

The European Commission has approved Horizon Therapeutics plc's (NASDAQ:HZNP) Uplizna (inebilizumab) as monotherapy for neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G seropositive (AQP4-IgG+). NMOSD is an autoimmune disease that attacks the optic nerve, spinal cord, brain, and brain stem. In the N-MOmentum pivotal clinical trial, Uplizna demonstrated a significant reduction…

The FDA approved an expanded indication for Supernus Pharmaceuticals Inc's (NASDAQ:SUPN) Qelbree (viloxazine extended-release capsules) for attention deficit hyperactivity disorder (ADHD) in adult patients aged 18 and older. The FDA has now approved Qelbree for ADHD in children (starting at age 6), adolescents, and adults. Qelbree is a novel non-stimulant taken once daily for…

Sage Therapeutics Inc (NASDAQ:SAGE) and Biogen Inc (NASDAQ:BIIB) have initiated a rolling submission of a marketing application to the FDA for zuranolone in major depressive disorder (MDD).  Zuranolone is an investigational two-week, once-daily oral drug developed for MDD and postpartum depression (PPD).  The companies have submitted the nonclinical module and plan to submit the remaining…

Gainers Redbox Entertainment Inc. (NASDAQ: RDBX) climbed 64.9% to $9.86. Redbox recently reported CFO transition.

Vaxxinity, Inc. (NASDAQ: VAXX) announced that UB-311 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of Alzheimer's disease.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Axsome Therapeutics, Inc. (NASDAQ: AXSM) regarding its New Drug Application (NDA) for AXS-07 for the acute treatment of migraine.

U.S. stocks traded mostly lower this morning, with the Dow Jones tumbling around 100 points on Monday.