FDA: Coronavirus (COVID-19) Update: FDA Issues Warning Letters to Companies Inappropriately Marketing Antibody Tests, Potentially Placing Public Health at Risk
Agency Continues Effort to Help Protect Public Health from Fraudulent Products
Latest News
PROTAGONIST THERAPEUTICS, INC.: Hepcidin Mimetic PTG-300 Receives U.S. FDA Orphan Drug Designation for the Treatment of Polycythemia Vera
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.
FRAGRANCE CREATORS: Applauds FDA for Continued Efforts to Promote Public Health
In a webinar for Fragrance Creators members, FDA delivered detailed instructions on registration and listing of hand sanitizers under the Agency's temporary guidance
AETHLON: Announces FDA Approval of IDE Supplement for COVID-19 Patients
Allows for enrollment of up to 40 subjects in up to 20 centers
ALMIRALL: Announces FDA Approval Of Updated Label For Seysara® (Sarecycline) Tablets
Seysara® is a novel oral antibiotic developed specifically for the treatment of acne
EPIZYME: Announces U.S. FDA Accelerated Approval of TAZVERIK™ (tazemetostat) for Relapsed/Refractory Follicular Lymphoma
TAZVERIK Now Approved for Second Indication
LOULOU FOUNDATION: CDKL5 Deficiency Disorder Voice of the Patient Report Submitted to FDA
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: Receives Rare Pediatric Disease Designation From U.S. Food and Drug Administration for Nedosiran for Treatment of Primary Hyperoxaluria
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).
FDA: Approves First Therapy for Rare Disease that Causes Low Phosphate Blood Levels, Bone Softening
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.
ABBVIE: FDA Accepts Supplemental Biologics License Application (sBLA) for BOTOX® (onabotulinumtoxinA) for the Treatment of Pediatric Patients with Neurogenic Detrusor Overactivity
Application Seeks to Extend Use of BOTOX® for Patients 5 to 17 Years Old
.jpg){kind=tracking}
FDA: Announces First of Its Kind Pilot Program to Communicate Patient Reported Outcomes from Cancer Clinical Trials
The U.S. Food and Drug Administration today launched Project Patient Voice, an initiative of the FDA’s Oncology Center of Excellence (OCE).
ZOGENIX, INC.: FDA Approves FINTEPLA® (fenfluramine) for the Treatment of Seizures Associated with Dravet Syndrome
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: Receives FDA Clearance of IND for Phase 2 Study of its Investigational Drug HST5040 for the Treatment of Methylmalonic Acidemia and Propionic Acidemia
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 HEALTHCARE SOLUTIONS: FUSION PPE Offers NIOSH and CDC Approved N95 Respirator Mask Produced by BYD
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
FDA: Approves New Therapy for Dravet Syndrome
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.
CITIUS: Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with COVID-19
FDA provides very specific guidelines to study iPSC-derived MSCs
NEXUS PHARMACEUTICALS, INC.: Announces Launch of Emerphed™ (ephedrine sulfate) RTU Injection, the First and Only FDA-approved, Ready-to-Use Ephedrine Injection (50 mg/10 mL vial)
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 THERAPEUTICS: Receives Another FDA Approval: Phase II Clinical Trial Using Mesenchymal Stem Cells (MSCs) as a Prophylactic Against COVID-19
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).
FDA: Approves Breast Cancer Treatment That Can Be Administered At Home By Health Care Professional
U.S. Food and Drug Administration approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer that has spread to other parts of the body, and for treatment of adult patients with early HER2-positive breast cancer. Patients should be selected based on an FDA-approved companion diagnostic test.
FDA: Approves First-Line Immunotherapy for Patients with MSI-H/dMMR Metastatic Colorectal Cancer
U.S. Food and Drug Administration approved Keytruda (pembrolizumab) for intravenous injection for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.