News by subject: FDA

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....

Catchword is thrilled to announce that Allergan VUITYtm, the first and only eye drop to treat presbyopia (age-related blurry near vision), has been approved by the FDA and is now available by prescription. Catchword created the name for the...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved two pediatric indications for XARELTO® (rivaroxaban): the treatment of venous thromboembolism (VTE, or blood...

Today, the U.S. Food and Drug Administration approved Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing at least 35 kilograms (77 pounds) for pre-exposure prophylaxis (PrEP) to reduce...

OrganOx, a world leader in normothermic machine perfusion (NMP), today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its metra system. The OrganOx metra is a fully automated NMP device for the...

Edwards Lifesciences today announced it received approval from the U.S. Food and Drug Administration (FDA) for the use of the Edwards SAPIEN 3 transcatheter valve with the Alterra adaptive prestent (SAPIEN 3 with Alterra) for patients with severe...

Poseida Therapeutics, Inc. , a clinical-stage biopharmaceutical company utilizing proprietary genetic engineering platform technologies to create cell and gene therapeutics with the capacity to cure, today announced that the U.S. Food and Drug...

Nextremity Solutions, Inc., a strategic commercialization organization with a focus on the extremity musculoskeletal space, located in "The Orthopedic Capital of the World," Warsaw, Ind., announced it has received 510(k) clearance by the Food & Drug...

Second Genome, a biotechnology company that leverages its proprietary platform sg-4sight to discover and develop precision therapies and biomarkers from public and proprietary microbiome data, today announced that the U.S. Patent and Trademark Office...

OrganOx, a world leader in normothermic machine perfusion (NMP), today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its metra system. The OrganOx metra is a fully automated NMP device for the...

The U.S. Food and Drug Administration today approved Vyvgart (efgartigimod) for the treatment of generalized myasthenia gravis (gMG) in adults who test positive for the anti-acetylcholine receptor (AChR) antibody. Myasthenia gravis is a chronic...

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Amgen and AstraZeneca's Tezspiretm (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe...

Medical devices company, Sky Medical Technology Ltd, has today announced U.S. Food and Drug Administration (FDA) 510(k) clearance to market the gekotm device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous...

Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced FDA clearance for a novel medical algorithm that analyzes ECG data from Implantable Loop Recorders (ILRs). The newly 510(k) cleared ILR ECG...

Curebase, a company committed to democratizing access to clinical studies, is pleased to have served as the technology partner for metaMe Health's Regulora®, the first FDA-authorized treatment of any kind specifically for abdominal pain associated...

Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved Injectafer for pediatric patients (who are 1 year of age or older) with iron deficiency...

Neuvivo, Inc., a company developing clinical-stage treatments for ALS and other neurodegenerative diseases, announced that it has submitted to the FDA a request for a Type C meeting to solicit feedback on the proposed development pathway for its lead...

Calliditas Therapeutics AB ("Calliditas") today announced that the US Food and Drug Administration (FDA) has approved TARPEYO (budesonide) delayed release capsules to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at...

The COVID-19 Research Database, a pro bono initiative led by numerous leading healthcare organizations, including Change Healthcare, Datavant, the Health Care Cost Institute (HCCI), Healthjump, Medidata (a Dassault Systèmes company), Mirador...

Today, the U.S. Food and Drug Administration approved Orencia (abatacept) for the prophylaxis (prevention) of acute graft versus host disease (aGVHD), a condition that occurs when donor bone marrow or stem cells attack the graft recipient, in...

Sapience Therapeutics, Inc., a biotechnology company focused on the discovery and development of peptide therapeutics to address difficult-to-treat cancers, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track...

Life Science Biosensor Diagnostics Pty Ltd (LSBD), a life sciences and medical technology company and subsidiary of The iQ Group Global, announced it has filed an application with the U.S Food and Drug Administration (FDA) for Breakthrough Devices...

Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) and granted Priority Review for spesolimab for the treatment of generalized pustular psoriasis (GPP) flares. ...

NTC Srl, R&D driven pharmaceutical company with headquarters in Italy, and I-MED Pharma Inc., a Canadian company specializing in dry eye diagnosis and management, announced today that I-DEFENSE®, a long-lasting, lubricating ointment containing 0.4%...

ViewRay, Inc. today announced that the company received FDA 510(k) clearance for its next generation of MRI-guided radiation therapy features, focused on enhancing on-table adaptive workflow and expanding clinical utility. MRIdian A3i includes a...

AbbVie today announced that the U.S. Food and Drug Administration (FDA) has approved RINVOQ® (upadacitinib; 15 mg, once daily) for the treatment of adults with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to...

OncoHealth, the leading digital health company focused on the physical, mental and financial complexities of cancer care, has released its quarterly report on the FDA's newly approved oncology drug indications. Highlights include new approvals in the...

Klox Technologies Inc. (Klox, or the Company), the leading provider of Fluorescent Light Energy (FLE)-based Systems for treating diseases and conditions affecting the skin and soft tissues, announces that the United States Food and Drug...

HealthTrackRx, the leading polymerase chain reaction (PCR) testing lab, today confirmed that it has retained Emergency Use Authorization (EUA) from the U.S. Food & Drug Administration (FDA) to perform the Molecular Laboratory Developed (LDT) COVID-19...

Bonumose, Inc. announces the achievement of regulatory and food application milestones in the United States and Canada for the low-glycemic, rare sugar tagatose, as the company progresses on time and on schedule for the opening of its first...

Ortho Regenerative Technologies Inc.  ("Ortho" or the "Company"), a clinical-stage orthobiologics company focused on the development of novel soft tissue repair regenerative technologies, announced today that the clinical hold on its U.S....

Brand Institute is proud to announce its successful partnership with Allergan, Inc., an AbbVie company, in naming VUITYtm, the first and only treatment approved by the U.S. Food & Drug Administration (FDA) to treat age-related blurry near vision...

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 clearance of the...

PharmaMar (MSE: PHM) and partner Jazz Pharmaceuticals plc today announced the initiation of a confirmatory Phase III clinical trial, LAGOON, evaluating Zepzelca® (lurbinectedin) for the treatment of patients with relapsed Small Cell Lung Cancer...

Galderma announced today the new label for SCULPTRA® (injectable poly-L-lactic acid (PLLA)), the first and only FDA-approved PLLA facial injectable treatment that helps stimulate the skin's own collagen production, to smooth facial wrinkles, such as...

Urotronic, Inc., a Minnesota based medical device company, today announced that the U.S. Food and Drug Administration (FDA) has...

Nuvation Bio Inc. , a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...

OpSens Inc. ("OpSens" or the "Company")  , a medical device cardiology-focused company delivering innovative solutions based on its proprietary optical technology, today announced that it has filed a 510(k) submission with the U.S. Food & Drug...

Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant , a publicly listed company that is majority-owned by Sumitovant, achieved significant...

Today, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine, authorizing the use of a single booster dose for administration to individuals 16 and 17 years of age at least six...

The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify non-small cell lung cancer (NSCLC) patients whose tumors carry epidermal...

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 that the U.S. Food and...

Tech company Cooler Heads today announced it has received FDA clearance to sell its revolutionary scalp cooling device to help cancer patients undergoing chemotherapy save their hair.  All the more impressive is that Cooler Heads achieved this...

SRI Biosciences has been awarded a $14.7 million contract sponsored by the Defense Threat Reduction Agency (DTRA) through the Medical, Chemical, Biological, Radiological, and Nuclear Defense Consortium (MCDC) to continue development of a...

Nuvation Bio Inc. , a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...

Saol Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has approved Saol's LYVISPAHtm (baclofen) oral granules....

Linus Biotechnology Inc., a leader in precision exposome sequencing, today announced that the U.S. Food and Drug Administration Center for Devices and Radiological Health has granted the Company's StrandDxtm-ASD diagnostic aid the designation as a...

Apotex Corp. has received approval and was granted a Competitive Generic Therapy (CGT) designation for its generic version of Atropine Sulfate Ophthalmic Solution USP, 1% by the U.S. Food and Drug Administration (FDA). As the first approved...

AMRA Medical, a ground-breaking digital health company and global leader in body composition analysis, announced today that the AMRA® MAsS Scan has received a 510(k) clearance from the FDA. This expands AMRA's reach with the MAsS Scan as it was...

Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), is pleased to announce that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for the company's...