FDA Signals Shortage Of ICU Medical’s Tracheostomy Tubes
The FDA said there was a shortage of tracheostomy tubes, including Bivona tracheostomy tubes manufactured by ICU Medical Inc (NASDAQ: ICUI). The agency…
Processa Says Successfully Identifies Next Generation Capecitabine Dosage Regimens For Phase 2B Trial
Next Generation Capecitabine (NGC) Dosage Regimens Have Been Identified In The Ongoing Phase
Harmony Biosciences Announces Topline Results From Phase 2 Proof-of-concept Study Evaluating Pitolisant For Excessive Daytime Sleepiness In Patients With Prader-Willii Syndrome
Harmony Biosciences Holdings, Inc. ("Harmony") (NASDAQ:HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases, today
Vigil Neuroscience Receives FDA Fast Track Designation For VGL101 For The Treatment Of Patients With ALSP
Vigil Neuroscience, Inc. (NASDAQ:VIGL), a clinical-stage biotechnology company committed to harnessing the power of microglia for the treatment of neurodegenerative diseases, today announced that the U.S. Food and
UNITY Biotechnology Announces 24-Week Data From Phase 2 BEHOLD Study Of UBX1325 In Patients With Diabetic Macular Edema
A single injection of UBX1325 led to a statistically significant and clinically relevant improvement in Best Corrected Visual Acuity (BCVA) of 7.6 ETDRS letters at 24 weeks compared to sham treatment
UBX1325
After FDA, European Agency Limits Use Of Certain JAK Inhibitors Amid Safety Concerns
The European Medicine Agency’s safety committee recommended that a group of JAK inhibitors for chronic inflammatory disorders be only used…
FDA Accepts For Priority Review Ascendis Pharma’s NDA For TransCon™ PTH In Adult Patients With Hypoparathyroidism
Ascendis Pharma A/S (NASDAQ:ASND) today announced that the U.S. Food & Drug Administration (FDA) has accepted for Priority Review its New Drug Application (NDA) for TransCon PTH (palopegteriparatide) in adult
Dyne Therapeutics Receives FDA Fast Track Designation For DYNE-251 For The Treatment Of Duchenne Muscular Dystrophy
Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases, today announced that the