News by subject: FDA

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...

Brand Institute is proud to announce its work with Mayne Pharma in developing the brand name HALOETTE®. HALOETTE® (etonogestrel and...

Serpex Medical announced today U.S. FDA 510(k) clearance of its Recon Steerable Sheath ? a steerable endobronchial tool that offers articulation at the distal tip to enable physicians to access difficult-to-reach areas of the lung anatomy. Serpex...

Vapor Cartridge Technology LLC, based in Stillwater Minnesota, has invented and patented a groundbreaking technology that portends the power to truly change the entire medical cannabis industry. Vapor Cartridge Technology LLC has invented and...

B.More Inc., a 501(c)(3) non-profit, clinical-stage biopharmaceutical company focused on the development of psychedelic medicines for substance abuse disorders, today announced that the U.S. Food and Drug Administration has approved its IND...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved IMBRUVICA® (ibrutinib) for the treatment of pediatric patients one year and older with chronic graft-versus-host...

The U.S. Food and Drug Administration approved the use of IMBRUVICA for the treatment of pediatric patients one year and older with cGVHD after failure of one or more lines of systemic therapyThis is the first approved treatment option for children...

NanoDx, Inc., a developer of breakthrough point-of-care diagnostic solutions and SkyWater Technology , the trusted technology realization partner, today announced the first commercially ready nano biosensor to yield a protein response. The unique...

Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for a generic version of Brovana® (Arformoterol Tartrate inhalation solution, EQ 0.015 mg...

The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLRtm, MedAlliance's novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US...

Ageless Biotech, Inc. Sheridan, WY a biotech company created to bring Stem Cell-based Therapeutics to market, is more than excited to have Simon MEd Imaging one of the major players in healthcare and the exciting Biotech research field helping ABT...

The first US patient has been enrolled in the FDA SELUTION4BTK (Below-the-Knee) clinical trial evaluating SELUTION SLRtm, MedAlliance's novel sirolimus-eluting balloon. This milestone follows Investigational Device Exemption (IDE) approval in the US...

Abbott's new Proclaimtm Plus spinal cord stimulation (SCS) system offers the next generation of stimulation therapy, giving physicians the ability to treat multi-site and evolving painThe system builds on the company's proprietary therapy, BurstDRtm...

KOAG LLC, a Minneapolis-based medical device firm engaged in the design of innovative, topical vascular closure systems, announced today it received FDA clearance for its Vascette® HP device. Vascette® is a unique, topical closure pad incorporating a...

Calyptus Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration ("FDA") granted approval to an Abbreviated New Drug Application (ANDA) for an AP-rated generic version of Cetrotide® (Cetrorelix Acetate for Injection, 0.25 mg/vial)...

Verismo Therapeutics, a Penn-spinout and the company behind the novel KIR-CAR platform technology for CAR T-cell therapy, today announced that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration...

Neurelis, Inc., is pleased to announce it has been named one of the Best Places to Work in SoCal 2022 by Best Companies Group (BCG), a BridgeTower Media Company. This distinction is based on responses from a detailed and comprehensive survey of its...

Zavation Medical Products ("Zavation" or the "Company"), an innovative designer and manufacturer of high-quality spinal implants, instruments, MIS procedural kits, and biologics headquartered in Flowood, MS, announced the FDA 510K Clearance of...

On April 27, 2022, GyroStim became the first FDA-cleared device for treating balance disorders to receive FDA designation as a...

Xenocor, a Utah-based medical device company, today announced newly issued U.S. patent protection for the Saberscope system from the United States Patent and Trademark Office (USPTO). The Saberscope system is the world's first true HD, fog free,...

Today, the U.S. Food and Drug Administration approved Zynteglo (betibeglogene autotemcel), the first cell-based gene therapy for the treatment of adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions....

Akorn Operating Company LLC, a specialty pharmaceutical company, announces that it received FDA approval for a generic version of Cetrorelix Acetate for Injection, 0.25 mg (Cetrorelix). This is the first approved AP-Rated bioequivalent version of...

Improvita, Inc., a Madison-based company affiliated with Innovenn, Inc., that focuses on human factors testing, ethnographic field research, user interface testing, and user experience testing for medical devices, software as a medical device, and...

Visibly, the developer of the world's first at-home digital vision testing platform, is excited to announce that, as of August 12, 2022, it has received 510(k) Clearance from the United States Food and Drug Administration for its Visibly Digital...

Bridge Biotherapeutics (KQ288330), a South Korean clinical-stage biotechnology company developing novel drugs for cancer, fibrosis and inflammation, announced it has received notice from the U.S. Food and Drug Administration (FDA) that it may proceed...

NovelMed Therapeutics is a clinical-stage biopharmaceutical company focused on the development of targeted therapies for complement-mediated rare diseases. The Company announced today that the U.S. Food and Drug Administration (FDA) cleared the...

BrainStorm Cell Therapeutics Inc. , a leading developer of adult stem cell therapeutics for neurodegenerative diseases, today announced financial results for...

Privo Technologies, Inc. ("Privo") announced today that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to Privo's PRV platform delivery of cisplatin for the treatment of carcinoma in situ (CIS) of the anterior 2/3...

We have received approval from the United States Food and Drug Administration (FDA) to import 150 metric tons (approx. 331,000 pounds) of infant formula base powder from Reckitt's nutrition facility in Delicias, Mexico. Once it is blended and...

Roche (SIX: RO, ROG; OTCQX: RHHBY)...

Halo Collective Inc. ("Halo" or the "Company") (NEO: HALO) (Germany: A9KN) today announced that its Budega Hollywood Dispensary, the Company's first superstore,  passed its Los Angeles Department of Cannabis Regulation (the "DCR") inspection and is...

It is a cloud-based Artificial Intelligence algorithm that classifies ECG signals. Without excessive human involvement, DeepRhytmAI is able to recognize a wide range of arrhythmia disorders for a more quick and accurate patient diagnosis. DeepRhytmAI...

SELUTION SLRtm, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral...

SELUTION SLRtm, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral...

SELUTION SLRtm, MedAlliance's novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral...

Avenda Health, an AI healthcare company creating the future of prostate cancer care, today announced its FocalPoint ablation system powered by iQuest, a patient management AI software, has received investigational device...

Immunis Inc., a private biotechnology company developing a novel treatment for age and disease-related immune decline, today announced that the U.S. Food and Drug Administration has approved it's Investigational New Drug application for a Phase 1/2a...

NeuroOne Medical Technologies Corporation ("NeuroOne" or the "Company"), a medical technology company focused on improving surgical care options and outcomes for patients suffering from neurological disorders, today announced that the Company...

Relmada Therapeutics, Inc. , a late-stage biotechnology company addressing diseases of the central nervous system (CNS), today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to REL-1017, the Company's...

CereVasc, Inc., a privately held, clinical-stage, medical device company developing novel, minimally invasive treatments for neurological diseases, announced today that the U.S. Food and Drug Administration (FDA) has approved an investigational...

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol® water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration...

SciBase Holding AB ("SciBase") [STO:SCIB], a leading developer of augmented intelligence-based solutions for skin disorders, announced today that the FDA (US Food and Drug Administration) held a meeting with the Medical Devices Advisory Committee on...

Bot Image, an Omaha-based MRI medical device company has developed an AI-driven medical device CAD software to significantly improve the accuracy and speed of prostate cancer detection (CADe) and diagnosis (CADx). The tool, called ProstatIDtm,...