News by subject: FDA

Alkermes plc  today announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States (U.S.) for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a...

Oyster Point Pharma, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYAtm (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the...

Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA...

Johnson & Johnson (the Company) today announced the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster...

Seqirus, a global leader in influenza prevention, and a business of CSL Limited , today announced that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company's cell-based quadrivalent...

Regeneron Pharmaceuticals, Inc.  today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized...

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the full approval of its Investigational...

Averix Bio is proud to announce that it has successfully completed an independent audit for 21 CFR Part 210 and Part 211 cGMP compliance of API phytocannabinoid CBD isolate in the U.S. as well as for ICH Q7 standards....

Cochlear Limited , the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval and clearance in the last month for its Cochleartm Remote Assist solution in the Nucleus® and Baha® Systems. The FDA...

Today, Withings, pioneers of the connected health revolution, is pleased to announce ScanWatch, its globally acclaimed and most medically advanced wearable, has received FDA clearance....

7 Daze LLC, a leading premium e-liquid manufacturer, revealed today that it has filed an appeal in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Food and Drug Administration (FDA) in response to FDA's issuance of a marketing denial...

Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. "Today's action marks the first...

Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the filing of an...

Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRTtm, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the...

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to...

Today, U.S. Senators Cory Booker, D-N.J., Rand Paul, R-Ky., Ben Ray Lujan, D-N.M., Mike Braun, R-Ind., and John Kennedy, R-La., introduced the FDA Modernization Act of 2021 to modernize drug development and to authorize the FDA to accept...

Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maventm, a novel radiofrequency ablation (RFA) catheter for...

Recursion , a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, machine learning and engineering, today announced that the U.S. Food and Drug Administration (FDA) has...

RedHill Biopharma Ltd. ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia® (omeprazole magnesium,...

Colospan  which develops novel solutions for colorectal surgery, announced today the appointment of Gregory D. Casciaro to its board of directors. "We are excited to welcome Greg to the Board of Directors. With four decades of medical device...

iotaMotion Inc., a leader in developing advanced surgical systems for cochlear implant surgery, announced FDA granted its' De Novo classification request to market the iotaSOFTtm insertion system. iotaSOFT is the world's first and only...

Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today announces its VCFix® spinal system, which aims to improve the treatment of vertebral fractures, has been granted the...

Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced submission of a...

Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. "Computed tomography is an important medical imaging tool that can aid in diagnosing disease,...

Immix Biopharma, Inc. ("ImmixBio"), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to...

ViewRay, Inc. today announced that the company has received acceptance from the FDA on their recent submission for new MRIdian features focused on enhancing on-table adaptive workflow efficiency and expanding clinical utility. ViewRay will be...

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®). This product was developed in collaboration...

BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first U.S. implant and full commercial launch of...

Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, is pleased to announce that its Phase III clinical study of the drug candidate, centhaquine, has been...

TransMedics Group, Inc. ("TransMedics") , a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has...

AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved QULIPTAtm (atogepant) for the preventive treatment of episodic migraine in adults.1 QULIPTA is the first and only oral calcitonin gene-related peptide (CGRP) receptor...

Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new indication for ERBITUX® (cetuximab injection) in combination with BRAFTOVI® (encorafenib), marketed by Pfizer, Inc., for the...

Nonagen Bioscience Corp, pioneers in the development of liquid biopsy tests for the detection of human cancers, today announced Oncuriatm, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food...

Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance, today announced that its Next Generation 'Phenotyping' (NGP) platform has received Breakthrough Device...

European Union regulatory submission planned by end of 2021 Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for...

BioArctic AB's (publ) partner Eisai today announced that they have initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), an investigational anti-amyloid beta...

Immunoforge (Co-CEOs Sung-min Ahn, Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 has received Orphan Drug Designation (ODD) from the U.S. FDA for the...

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Repatha® (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10...

Nutricia North America ("Nutricia") today announced that the U.S. Food and Drug Administration (FDA) has completed its review of its infant nutrition product, Fortinitm. The new infant formula supports catch-up growth in infants with, or at risk of,...

MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received FDA 510(k) clearance for the detection of wounds containing clinically...

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that its novel MDM2-p53 inhibitor alrizomadlin (APG-115) has been...

Cantargia AB today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation in the US to nadunolimab (CAN04) for the treatment of pancreatic cancer. This provides access to various incentives in the continued...

Endo International plc announced today that one of its operating companies, Par Pharmaceutical, Inc. (Par), has begun shipping the generic version of Pfizer's Chantix® (varenicline), 0.5 mg and 1 mg tablets, following final approval from the U.S....

United Imaging, a global leader in advanced medical imaging and radiotherapy equipment, announced FDA clearance for the uCT ATLAS, the latest in the company's Computed Tomography (CT) portfolio of scanners and the 25th FDA clearance for the company...

Kleiner Device Labs today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) market clearance for its KGtm2 Surgetm flow-thru interbody system.  The system maximizes total bone graft delivery volume, better distributes...

CARISMA Therapeutics Inc., a clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced today that that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to...

Moberg Pharma AB (OMX: MOB) today announces that it has received approval of the pediatric plan for MOB-015 from EMA's paediatric committee (PDCO). This approval enables the company to pursue a full marketing authorization application providing up to...

Mayne Pharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved LEXETTE® (halobetasol propionate) foam, 0.05% for use in adolescents. LEXETTE, a super potent topical corticosteroid, is now approved for the treatment...

The U.S. Food and Drug Administration today approved Byooviz (ranibizumab-nuna) as the first biosimilar to Lucentis (ranibizumab injection) for the treatment of several eye diseases and conditions, including neovascular (wet) age-related macular...