.jpg){kind=tracking}
The U.S. Food and Drug Administration approved Ilaris (canakinumab) injection for the treatment of Active Still’s disease, including Adult-Onset Still’s Disease (AOSD). Ilaris was previously approved for Systemic Juvenile Idiopathic Arthritis (SJIA) in patients aged 2 years and older.
The U.S. Food and Drug Administration revoked the emergency use authorization (EUA) of the Chembio Diagnostic System, Inc. (Chembio) DPP COVID-19 IgM/IgG System, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.
Agency Continues Effort to Help Protect Public Health from Fraudulent Products
Protagonist Therapeutics, Inc. (Nasdaq: PTGX) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for PTG-300 for the treatment of polycythemia vera.
In a webinar for Fragrance Creators members, FDA delivered detailed instructions on registration and listing of hand sanitizers under the Agency's temporary guidance
Allows for enrollment of up to 40 subjects in up to 20 centers
Seysara® is a novel oral antibiotic developed specifically for the treatment of acne
TAZVERIK Now Approved for Second Indication
The Loulou Foundation and the International Foundation for CDKL5 Research (IFCR) are proud to release the “CDKL5 Deficiency Disorder Voice of the Patient Report”, capturing the voice of patients living with this rare genetic disease that affects thousands of people.
Dicerna Pharmaceuticals, Inc. (Nasdaq: DRNA) (the “Company” or “Dicerna”), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced that the U.S. Food and Drug Administration (“FDA” or the “agency”) has granted rare pediatric disease designation for nedosiran, an investigational RNAi therapy being developed as a once-monthly treatment for primary hyperoxaluria (PH).
The U.S. Food and Drug Administration approved Crysvita (burosumab-twza) injection to treat patients age two and older with tumor-induced osteomalacia (TIO), a rare disease that is characterized by the development of tumors that cause weakened and softened bones. The tumors associated with TIO release a peptide hormone-like substance known as fibroblast growth factor 23 (FGF23) that lowers phosphate levels.
Application Seeks to Extend Use of BOTOX® for Patients 5 to 17 Years Old
.jpg){kind=tracking}
The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE).
FINTEPLA® significantly and substantially reduced convulsive seizure frequency in patients whose seizures were not adequately controlled on other medications, as observed in two phase 3 placebo-controlled clinical trials
HemoShear Therapeutics, a clinical stage company developing treatments for rare metabolic disorders, has received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a phase 2 clinical trial of HST5040, an oral small molecule drug for the treatment of patients with methylmalonic acidemia (MMA) and propionic acidemia (PA).
FUSION PPE Offers NIOSH and CDC Approved N95 Respirator Mask Produced by BYD, Backed by Warren Buffet, As Covid-19 Surges with Potential Second Wave, and FDA Reissues Emergency Use Authorizations (EUAs) Revising Which Respirators Can Be Decontaminated for Reuse
The U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.
FDA provides very specific guidelines to study iPSC-derived MSCs
Nexus Pharmaceuticals, Inc. issued the following announcement on June 26.Nexus Pharmaceuticals announced that it has launched its patent-pending New Drug Application (NDA) Emerphed, the first and only premixed ephedrine in a ready-to-use 50 mg/10 mL vial.
Celltex, a Houston, Texas-based biotechnology company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Company’s Investigational New Drug application (IND 22055) to investigate the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus Disease 2019 (COVID-19).