News by subject: FDA

Bracco Diagnostics Inc., the...

Guerbet, a global leader in medical imaging with more than 30 years of experience in MRI, and the first to bring a macrocyclic GBCA to the global market, is proud to announce...

- FDA approval of Eluciremtm (NDA 216986) was granted after priority review, a designation assigned to applications for drugs that provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious...

Biocodex, Inc., a pharmaceutical company and manufacturer of DIACOMIT® (stiripentol), announced today that the U.S. Food and Drug Administration (FDA) has approved DIACOMIT for the treatment of seizures associated with Dravet syndrome in patients 6...

Charsire Biotechnology Corp. has successfully developed a revolutionary new drug (BAC) for Alzheimer's disease and vascular dementia using its patented technology of Multi-Glycan Complex and soybeans as raw materials. BAC has completed Phase II...

Immunitas Therapeutics ("Immunitas"), a precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, today announced that the U.S. Food and Drug Administration...

Stryker , one of the world's leading medical technology companies, announced today that its OptaBlate bone tumor ablation system (OptaBlate) received 510(k) clearance from the U.S. Food and Drug Administration. The addition of the OptaBlate...

Medtronic plc , a global leader in healthcare technology, today announced the LINQ IItm Insertable Cardiac Monitor (ICM) system is the first-and-only ICM to receive 510(k) clearance by the U.S. Food and Drug Administration (FDA) for use in pediatric...

Verismo Therapeutics, a clinical-stage biotechnology company and a Penn-spinout behind the novel KIR-CAR platform technology, today announced that is has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug...

Alterity Therapeutics ("Alterity" or "the Company"), a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, today announced the approval of its Investigational New Drug (IND) application by the...

Zimmer Biomet Holdings, Inc. , a global medical technology leader, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the Identitytm Shoulder System for anatomic, reverse and revision shoulder replacement. The Identity...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), today announced that its two Drug Substance (DS) facilities and a Drug Product (DP) facility located in Wuxi city received...

Advanced NanoTherapies, Inc., a privately-held medical device company committed to solving vascular disease's most significant challenges through the creative applications of nanotechnology, today announced the U.S. Food and Drug Administration (FDA)...

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for hematology...

The US FDA has granted an Investigational Device Exemption (IDE) approval for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR). US FDA's IDE approval allows the MagicTouch SCB to be used in a pivotal clinical study to...

The US FDA has granted an Investigational Exemption (IDE) approval Device for MagicTouch Sirolimus Coated Balloon (SCB) indicated for In-Stent Restenosis (ISR)....

Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class...

The Rare Disease Cures Accelerator-Data and Analytics Platform initiative (RDCA-DAP®) hosted an all-day workshop and annual meeting September 13 and 14 in Washington. The in-person and livestream event for rare disease stakeholders featured expert...

Edwards Lifesciences Corporation , today announced the company's PASCAL Precision transcatheter valve repair system for transcatheter edge-to-edge repair (TEER) has received FDA approval for the treatment of patients with degenerative mitral...

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 received 510(k) regulatory clearance from the U.S. Food &...

Critical Path Institute (C-Path) has announced it will serve as the convener of the Critical Path for Rare Neurodegenerative Diseases (CP-RND), a new public-private partnership (PPP) to benefit people across multiple rare neurodegenerative diseases,...

Ark Surgical Ltd., an Israeli medical device company, announced today that it has received US Food and Drug Administration (FDA) clearance for its patented LapBox tissue containment removal system for manual morcellation. Designed to enable...

Potrero Medical announced today that the FDA granted Breakthrough Device Designation for their AKI Predict machine learning algorithm, for the advanced prediction of acute kidney injury (AKI) associated with intra-abdominal hypertension (IAH) in...

Ventris Medical, a privately held orthobiologics and tissue regeneration company, today announced that the United States Food and Drug Administration has granted 510(k) clearance for Synthetic Bone Graft Putty (Amplify®). Amplify® represents a new...

ABK Biomedical, Inc., an innovative medical device company dedicated to the research, development, and commercialization of advanced imageable embolic therapies, announces FDA 510(k) clearance of Easi-Vue embolic microspheres for the treatment of...

Brand Institute is proud to announce its work with Revance Therapeutics in developing the brand name DAXXIFYtm, which was approved by the FDA on September 7, 2022. Brand Institute was also involved in the development of the corresponding...

CurveBeam AI, Ltd announced its medical diagnostic software, OssViewtm, has received US Food and Drug Administration (FDA) Breakthrough Device Designation. OssView calculates a Structural Fragility Score (SFS), which determines bone microstructural...

Chiesi Global Rare Diseases, a business unit of Chiesi Farmaceutici S.p.A., an international research-focused healthcare Group (Chiesi Group), announced today that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License...

By the time you test positive for COVID-19, the SARS-CoV-2 virus has already taken up residence in your respiratory system. With each breath, you expel invisible viral particles into the air?a process known as viral shedding. Existing drugs aimed at...

The MedTech company NeoDynamics has today received approval for its innovative pulse biopsy system NeoNavia® from the US Food and Drug Administration, FDA. The US breast biopsy market is estimated to reach $830 million by 2025. "The FDA approval for...

Ceribell, Inc. announced today that it has received Breakthrough Device Designation for its delirium indication from the United States Food and Drug Administration (FDA). A first-of-its-kind technology, the Ceribell® system utilizes machine learning...

Sciton Inc., a leading manufacturer of medical and aesthetic lasers and light sources, proudly announces the 510K FDA tool clearance received on July 16 for their diVa handpiece. The FDA's tool clearance will allow Sciton to continue to provide...

Integral Molecular, the leader in antibody discovery against membrane proteins, has been accepted into the U.S. Food & Drug Administration (FDA)'s ISTAND pilot program. This program supports Innovative Science and Technology Approaches for New Drugs...

Serpex Medical announced today U.S. FDA 510(k) clearance of its Compass Steerable Needles ? steerable biopsy needles that enable precise access to lung nodules in the intrapulmonary region. Serpex Medical seeks to leverage the power of steerable...

Cipla Limited (BSE: 500087) (NSE: CIPLA EQ) ("Cipla") announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the United States Food and Drug...

QOL Medical, LLC, a ground-breaking, rare disease pharmaceutical company, announced today that the United States (U.S.) Food & Drug Administration (FDA) approved Sucraid® single-use containers for patients more than 33 lb (15 kg) with Congenital...

Moleculin Biotech, Inc., ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, today announced that the U.S. Food and Drug Administration...

Eiger BioPharmaceuticals, Inc. , a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, today provided an update on the status of its planned request...

Boston Scientific Corporation has received U.S. Food and Drug Administration (FDA) approval to expand the instructions for use labeling for the current-generation WATCHMAN FLXtm Left Atrial Appendage Closure (LAAC) Device to include a 45-day dual...

Azurity Pharmaceuticals, a pharmaceutical company focused on developing innovative dose-forms and formulations of products to serve the needs of overlooked patients, announced today that the U.S. Food and Drug Administration (FDA) has approved...

Boehringer Ingelheim announced today the U.S. Food and Drug Administration has approved SPEVIGO, the first approved treatment option for generalized pustular psoriasis (GPP) flares in adults. SPEVIGO is a...

LASEROPTEK Co., Ltd., a developer, and manufacturer of world-class laser devices for aesthetic and medical dermatology applications, is pleased to announce its HELIOS IV-785 laser system recently received...

Aston Sci. Inc., a clinical stage biopharmaceutical company specializing in clinical development of therapeutic cancer...

Revelle Aesthetics, Inc. (Revelle) ? a VC-backed Silicon Valley MedTech company ? achieves an extended FDA clearance for its precision cellulite release device, Avélitm. Marking another key milestone for the Company, Avéli is now indicated for...

eCential Robotics, a French growth MedTech company that designs and produces a system unifying 2D/3D imaging, surgical navigation and robotics, today announced FDA 510(k) clearance of its 3D imaging, navigation and robotics guidance system, securing...

Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Xenpozyme is...

United BioPharma (UBP) announced today that the U.S. Food and Drug Administration (FDA) has approved a phase 2 clinical trial IND submitted by the U.S. National Institute of Allergy and Infectious Diseases (NIAID) of NIH. The purpose of this study is...

Rafa Laboratories LTD. ("Rafa") is pleased to announce the U.S. Food and Drug Administration has approved its "first in market" 10 mg midazolam autoinjector for the treatment of status epilepticus in adults....

Southern California cord blood regenerative therapeutics company StemCyte is pleased to announce it has received approval from the U.S. Food and Drug Administration (FDA) for their Phase II clinical trial for Post-COVID Syndrome (or PCS) using...