News by subject: FDA

Glenmark Pharmaceuticals Limited, a research-led, global integrated   pharmaceutical company announced that its fully owned subsidiary Glenmark Specialty S.A. (Switzerland), received FDA approval on its New Drug Application (NDA) for Ryaltristm, an...

We are advised by RapidRona that journalists and other readers should disregard the news release, FDA Grants Emergency Use Authorization to Premier Medical Laboratory Services for At-home COVID-19 Test, issued 13-Jan-2022 over PR Newswire. SOURCE...

Premier Medical Laboratory Services (PMLS), one of the largest private medical diagnostics laboratories in the US has provided results for millions of COVID-19 tests since the beginning of the pandemic, contributing largely to the national COVID-19...

Today, the U.S. Food and Drug Administration approved Solensia (frunevetmab injection), the first treatment for the control of pain associated with osteoarthritis in cats and the first monoclonal antibody (mAb) new animal drug approved by the FDA for...

Mentor Worldwide LLC, the number one global brand in breast aesthetics, and part of the Johnson & Johnson Medical Devices Companies** today announced that the U.S. Food and Drug Administration (FDA) approved the MENTOR® MemoryGel BOOSTtm Breast...

Wavegate Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its StimuLuxtm optical reflectometry system for closed-loop adaptive modulation of spinal cord stimulation. The FDA's...

Andelyn Biosciences, a pioneering cell and gene therapy CDMO born out of Nationwide Children's Hospital, today announced the U.S. FDA's acceptance of its GMP plasmid DNA drug master file (DMF), which enables the organization to vertically integrate...

Abbott  today announced it has received clearance from the U.S. Food and Drug Administration for the EnSitetm X EP System with EnSite Omnipolar Technology (OT), a new cardiac mapping platform available in the U.S. and across Europe that is designed...

Cellular Biomedicine Group Inc. (CBMG or the "Company"), a biopharmaceutical company developing innovative cellular immunotherapies for the treatment of cancer, today announced that the Food and Drug Administration (FDA) granted C-CAR039, a novel...

Cochlear Limited , the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval of Cochleartm Nucleus® Implants for the treatment of unilateral hearing loss (UHL)/single-sided deafness (SSD).  ...

SNIPR BIOME ApS, a leading CRISPR and microbiome biotechnology company, is pleased to announce that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) Application, for our first development candidate, enabling...

Medtronic plc , a global leader in healthcare technology, today announced it has received approval from Japan's Ministry of Health, Labor and Welfare for the sale and reimbursement of the Micratm AV Transcatheter Pacing System (TPS), and the company...

The approval of QUVIVIQtm ? 25 & 50 mg ? is based on a robust Phase 3 clinical program that demonstrated significant improvement versus placebo on objective measures of sleep onset and sleep maintenance, as well as patient reported total sleep time...

Medtronic plc , a global leader in healthcare technology, today announced the National Medical Products Administration (NMPA) has approved the CoreValvetm Evoluttm PRO TAVR system for the treatment of severe aortic stenosis (AS) for symptomatic...

COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles (CNPs) to treat immune disorders, today announced the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to the Company's...

Amgen today announced that the European Commission (EC) has granted conditional marketing authorization for LUMYKRAS® (sotorasib), a first-in-class KRASG12C inhibitor, for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with...

BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the BD Kiestratm IdentifA system, which is designed to...

Dynacure, a clinical stage biotechnology company focusing on Myotubular and Centronuclear Myopathies (CNM), a group of rare, debilitating, and life-threatening genetic diseases, today announced that the U.S. Food and Drug Administration (FDA) has...

Jubilant Therapeutics Inc, a biopharmaceutical company advancing small molecule precision therapeutics to address unmet medical needs in oncology and autoimmune diseases, today announced U.S. Food and Drug Administration (FDA) clearance of the...

COPAN Diagnostics is proud to announce the FDA clearance of Colibritm, an automated processor that is a complementary part of WASPLab®, COPAN's full laboratory automation system. The COPAN Colibritm System is an in vitro diagnostic device for use in...

Helios Cardio Inc. announces the Food and Drug Administration (FDA) 510(k) clearance for commercial distribution of CardiaMendtm Pericardial and Epicardial Reconstruction Matrix....

Meridian Bioscience, Inc. , a leading global provider of diagnostic testing solutions and life science raw materials, announced today that the Curian® Campy assay has received U.S. Food and Drug Administration (FDA) clearance.  The Curian Campy assay...

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced the U.S. Food and Drug Administration (FDA) has granted approval for an amendment to the company's...

NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the Company received U.S. Food and Drug Administration (FDA) 510(k)...

Biohaven Pharmaceutical Holding Company Ltd. and Pfizer Inc. , today announced that the parties have completed the collaboration transaction between the two companies. The transaction agreements, including Pfizer's commercialization of rimegepant...

URO-1 Inc., www.uro1medical.com, an innovator of medical devices for urology and urogynecology, today announced achievement of multiple milestones toward commercializing its breakthrough products for prostate biopsy and other procedures....

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved new expanded magnetic resonance imaging (MRI) compatibility for its Proclaimtm XR Spinal Cord Stimulation (SCS) System with Octrodetm leads. The new labeling lifts...

AbbVie announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation (BTD) to investigational telisotuzumab vedotin (Teliso-V) for the treatment of patients with advanced/metastatic epidermal growth factor...

Werfen today announced the 510(k) clearance of the GEM Hemochron 100 whole blood hemostasis system by the US Food and Drug Administration (FDA). Leveraging leading Hemochron technology, the GEM Hemochron 100 system, delivers fast, actionable...

SpliSense, a biopharmaceutical company developing transformative mRNA-altering therapies for cystic fibrosis (CF) and other pulmonary diseases, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)...

Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic...

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the use of a single booster dose to include use in individuals 12 through 15 years of age. Shorten the time...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume, today...

On December 23, Regor Therapeutics, a clinical-stage biotech company, announced authorization from the US Food and Drug Administration (FDA) to proceed with Regor's Phase 1 clinical development plans for RGT-419B. RGT-419B is a new generation...

Envista Holdings Corporation ("Envista") today announced that the U.S. Food and Drug Administration (FDA) has cleared the Nobel Biocare N1tm implant system. Boasting a biologically driven design of components and forward-thinking treatment...

BrainStorm Cell Therapeutics Inc. , a leading developer of cellular therapies for neurodegenerative diseases, today announced plans for a dosing extension of NurOwn® for participants who completed the Expanded Access Protocol (EAP). The U.S. Food and...

BioArctic AB's (publ)  partner Eisai announced today that lecanemab, an investigational anti-amyloid beta (A?) protofibril antibody for the treatment of early Alzheimer's disease (AD), was granted Fast Track designation by the U.S. Food and Drug...

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") and Biogen Inc.  announced today that lecanemab, an investigational anti-amyloid beta (A?) protofibril antibody for the treatment of early Alzheimer's disease (AD), was granted Fast...

Sedana Medical AB (publ) (SEDANA: FN Stockholm) today announces that the company has received Investigational New Drug (IND) clearance from the US Food and Drug Administration (FDA) to initiate phase III pivotal clinical trials with its Sedaconda...

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Merck's molnupiravir for the treatment of mild-to-moderate coronavirus disease (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing,...

Today, the U.S. Food and Drug Administration authorized the marketing of 22nd Century Group Inc.'s "VLN King" and "VLN Menthol King" combusted, filtered cigarettes as modified risk tobacco products (MRTPs), which help reduce exposure to, and...

Lion TCR Pte Ltd today announced that it has received Fast Track Designation from United States Food and Drug Administration (U.S. FDA) for LioCyx-M004, autologous T-cells transfected with mRNA encoding Hepatitis B surface antigen (HBsAg) specific...

Novartis, a leader in rheumatology and immuno-dermatology, today announced the US Food and Drug Administration (FDA) has approved Cosentyx® (secukinumab) for the treatment of active enthesitis-related arthritis (ERA) in patients four years and older,...

Novartis today announced the US Food and Drug Administration (FDA) approval of Leqvio® (inclisiran), the first and only small interfering RNA (siRNA) therapy to lower low-density lipoprotein cholesterol (also known as bad cholesterol or LDL-C) with...

Tryp Therapeutics ("Tryp" or the "Company"), a pharmaceutical company focused on developing psilocybin-based compounds for diseases with unmet medical needs, announced today that it has received confirmation from the U.S. Food and Drug...

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer's Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment of mild-to-moderate coronavirus disease (COVID-19)...

Novadoz Pharmaceuticals is excited to announce that their corporate group entity, MSN Pharmaceuticals, has cleared USFDA audit with zero observations for their new, state-of-the-art, 200,000 sq. ft. manufacturing facility in Piscataway, NJ.  This new...

Ortho Regenerative Technologies Inc. ("Ortho" or the "Company"), a clinical stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, today reported its financial results and highlights for the...

Today, the U.S. Food and Drug Administration conditionally approved Canalevia-CA1 (crofelemer delayed-release tablets) for the treatment of chemotherapy-induced diarrhea in dogs. This is the first treatment to be approved for this condition....

Hydrozid®, a leading cryosurgery device in Europe, is now FDA cleared and available to qualified providers in the U.S. Designed for primary care physicians, pediatricians, dermatologists, podiatrists, and other medical specialties, Hydrozid is a...