Recap Of Thursday’s Biotech Catalysts – End Of the Day Summary
The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ:KRYS) Biologics License Application (BLA)…
FDA Accepts Krystal Biotech’s Filing For Genetic Skin Disorder Candidate Under Priority Review
The US Food and Drug Administration (FDA) has accepted for filing Krystal Biotech’s (NASDAQ: KRYS) Biologics License Application (BLA) for its lead candidate B-VEC in the treatment of patients with dystrophic epidermolysis bullosa (DEB).
FDA Accepts Krystal Biotech’s Biologics License Application For Dystrophic Epidermolysis Bullosa
FDA granted Priority Review designation
PDUFA target action date is February 17, 2023
FDA stated that it is not currently planning to hold an advisory committee meeting
Astellas’ Menopause Drug Under FDA Review
The FDA accepted Astellas Pharma Inc’s (OTC:ALPMF) menopause treatment for approval five months after the therapy hit a speed bump in…
AIM Immunotech Announces Commencement Of Phase 2 Study Of Ampligen For The Treatment Of Pancreatic Cancer
AIM ImmunoTech Inc. (NYSE:AMERICAN) ("AIM" or the "Company"), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune
FDA Alerts Patients, Caregivers, And Health Care Providers Of Cross-Compatibility Issues With Autoinjector Devices That Are Optional For Use With Glatiramer Acetate Injection
Received Reports That Using Autoinjector Not Compatible With Specific Glatiramer Acetate Injection Drug Product Resulted In Missed, Partial Doses
FDA Clears Curis’ Lymphoma Study, Keeping Leukemia Trial Still Stalled
The FDA has lifted the partial clinical hold on Curis Inc’s (NASDAQ:CRIS) TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing the…
ABVC BioPharma Says Phase II Vitargus Clinical Trial Receives Local Ethics Committee Approval In Thailand
ABVC BioPharma, Inc. (NASDAQ:ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, CNS, and ophthalmology, today announced that, on August 2, 2022, approval was
Arcturus Reports Durability Data Against Omicron Variants, Including BA.5, At Six-Month Timepoint Following Booster With ARCT-154 COVID-19 Vaccine
New clinical data demonstrate high and sustained geometric mean fold rises (GMFR) in neutralizing antibodies against all evaluated Omicron variants
Six months after booster dose of ARCT-154:
BA.1: GMFR = 22 to 52;