FDA Advisory Committee Meeting Scheduled For October 28, 2022 To Review Y-mAbs’ Refiling For Omburtamab
The Oncologic Drugs Advisory Committee (ODAC) of the U.S.
Intellia Gets FDA Orphan Drug Status For Hereditary Angioedema Candidate
The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Intellia Therapeutics’ (NASDAQ: NTLA) lead asset NTLA-2002, for the treatment of hereditary angioedema (HAE).
NTLA-2002 is currently being evaluated in a Phase 1/2 study in adults with Type I or Type II HAE.
Europe Backs Approval Of Omicron-Adapted COVID-19 Vaccines
Health Canada has approved Moderna Inc's (NASDAQ:
Werewolf Shares Climb As Initial-Stage Solid Tumors Study Kicks-off
Werewolf Therapeutics (NASDAQ: HOWL) has initiated patient dosing in a Phase 1/1b clinical trial evaluating WTX-124, its lead INDUKINET molecule targeting IL-2 for the treatment of solid tumors.
BARDA Backs Arcturus’ Influenza Vaccine Program
Arcturus Therapeutics Holdings Inc (NASDAQ:ARCT) received an award for up to $63.2 million from the Biomedical Advanced Research and Development Authority…
AnaptysBio Faces Another Setback For Imsidolimab, Stalls Work In Skin Scarring Indication
AnaptysBio Inc (NASDAQ: ANAB) announced topline data from its HARP Phase 2 trial of imsidolimab for moderate-to-severe hidradenitis suppurativa (HS).
Health Canada Authorizes Moderna’s Bivalent Covid Booster Dose For People Aged 18 And Older
- Reuters Citing Government Website
https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/drugs-vaccines-treatments/vaccines/moderna.html
Pfizer And BioNTech Receive Positive CHMP Opinion For Omicron BA.1-Adapted Bivalent COVID-19 Vaccine Booster In European Union
CHMP recommendation based on safety, tolerability, and immunogenicity data from a Phase 2/3 trial of the Omicron BA.1-adapted bivalent vaccine
The Omicron BA.1-adapted bivalent COVID-19 vaccine combines
Cue Health Makes De Novo Submission to FDA For Full Clearance Of Its Cue Flu Molecular Test
SAN DIEGO, Sept. 1, 2022 /PRNewswire/ -- Cue Health ("Cue") (NASDAQ: HLTH) today announced that it has made a de novo submission to the U.S. Food and Drug Administration (FDA) for fullSAN DIEGO, Sept.
Vaxart Shares Positive Top-line Data From Mid-Stage Oral Pill COVID-19 Vaccine Study
Vaxart (NASDAQ: VXRT) announced positive top-line data from the first part of a planned two-part Phase 2 study of its Wuhan S-only oral pill COVID-19 vaccine candidate, VXA-CoV2-1.1-S.
The top-line data readout exhibited that the trial met its primary safety and secondary immunogenicity endpoints.