FDA: Reminds Patients that Devices Claiming to Clean, Disinfect or Sanitize CPAP Machines Using Ozone Gas or UV Light Have Not Been FDA Authorized
To ensure the safe and effective cleaning of CPAP devices and accessories, the FDA is recommending that consumers and health care providers follow the cleaning instructions provided by the CPAP’s manufacturer, which normally include regular cleaning with soap and water.
ALKERMES: Announces U.S. Food and Drug Administration Acceptance of ALKS 3831 New Drug Application for Treatment of Schizophrenia and Bipolar I Disorder
Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's New Drug Application (NDA) seeking approval of ALKS 3831 (olanzapine/samidorphan) for the treatment of schizophrenia and for the treatment of bipolar I disorder.
GLAXOSMITHKLINE: US Food and Drug Administration (FDA) grants priority review of belantamab mafodotin for patients with relapsed or refractory multiple myeloma
Biologics License Application based on results from the pivotal DREAMM-2 study of immunoconjugate targeting B-cell maturation antigen (BCMA) in heavily pre-treated patient population who was refractory to an immunomodulatory drug and a proteasome inhibitor, and refractory or intolerant to an anti-CD38 antibody
POLARYX THERAPEUTICS: Submits Investigational New Drug Application to the U.S. FDA for the Treatment of Late Infantile Neuronal Ceroid Lipofuscinosis With PLX-200
Polaryx Therapeutics Inc, a biotech company developing patient-friendly small molecule therapeutics for lysosomal storage disorders, such as Late Infantile Neuronal Ceroid Lipofuscinosis (LINCL) and other forms of NCL, announced that the Company has submitted an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA) for the treatment of patients with LINCL.
ASTELLAS: FDA Grants Accelerated Approval to Astellas’ and Seattle Genetics’ PADCEV™ (enfortumab vedotin-ejfv) for People with Locally Advanced or Metastatic Urothelial Cancer, the Most Common Type of Bladder Cancer
First-in-Class Antibody-Drug Conjugate Directed Against Nectin-4, a Protein Highly Expressed in Urothelial Tumors
GILEAD: Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment
Gilead Sciences, Inc. (NASDAQ: GILD) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for filgotinib, an investigational, oral, selective JAK1 inhibitor for the treatment of adults who are living with moderate-to-severe rheumatoid arthritis (RA). A priority review voucher was submitted with the NDA, shortening the anticipated time for review.
EPIZYME: Submits New Drug Application to the U.S. FDA for Tazemetostat for the Treatment of Patients with Follicular Lymphoma
Submission Marks On-time Execution of Second NDA Submission for Tazemetostat in 2019
PFIZER: U.S. FDA Accepts and Grants Priority Review to sNDA for BRAFTOVI® (encorafenib) in Combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) for the Treatment of BRAFV600E-Mutant Metastatic Colorectal Cancer After Prior Therapy
Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review to the Company’s supplemental New Drug Application (sNDA) for BRAFTOVI® (encorafenib) in combination with ERBITUX® (cetuximab) (BRAFTOVI Doublet) based on results from the Phase 3 BEACON CRC trial, which evaluated the efficacy and safety of BRAFTOVI in combination with ERBITUX with or without MEKTOVI® (binimetinib) in patients with advanced BRAFV600E-mutant metastatic colorectal cancer (mCRC), following one or two lines of therapy.
3DBIO THERAPEUTICS: Receives FDA Rare Pediatric Disease Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
INNOVENT BIOLOGISTICS: Announces FDA Acceptance of NDA for Pemigatinib in Patients with Previously Treated, Locally Advanced or Metastatic Cholangiocarcinoma with FGFR2 Fusions or Rearrangements
Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, announced that the new drug application ("NDA") submitted by Incyte to the U.S. Food and Drug Administration ("FDA") for pemigatinib in previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements has been accepted for Priority Review by FDA.
SFA THERAPEUTICS, INC.: Receives an FDA Orphan Drug Designation (ODD) for SFA001 in the Treatment of Hepatocellular Carcinoma (HCC)
SFA Therapeutics, Inc. announced today that FDA has granted an official Orphan Drug Designation (ODD) to SFA001, the company's novel human-microbiome-based treatment for human hepatocellular carcinoma (HCC).
U.S. FDA: Statement from Acting FDA Commissioner Ned Sharpless, M.D., and Center for Drug Evaluation and Research Director Janet Woodcock, M.D., on the agency's efforts to protect patients from potentially harmful drugs sold as homeopathic products
The U.S. Food and Drug Administration (FDA) recognizes that consumers may use various types of unapproved drugs, such as homeopathic drug products, to treat or relieve different diseases and conditions.
U.S. FDA: FDA's Center for Devices and Radiological Health, on the agency's continued efforts to protect women's health and enhance safety information available to patients considering breast implants
FDA recommends including a boxed warning and other elements in breast implant labeling
U.S. FDA: FDA, FTC warn company marketing unapproved cannabidiol products with unsubstantiated claims to treat teething and ear pain in infants, autism, ADHD, Parkinson’s and Alzheimer’s disease
FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD
ENLIGHTENVUE: enlightenVue's Single Use Micro-Endoscope complies with new FDA recommendations to increase patient safety
The innovative micro-endoscope with multiple working channels is single use, eliminating the risk of transmitting infections among patients.