News by subject: FDA

Today, the U.S. Food and Drug Administration approved Jesduvroq tablets (daprodustat) as the first oral treatment for anemia (decreased number of red blood cells) caused by chronic kidney disease for adults who have been receiving dialysis for at...

The Mays Cancer Center, home to UT Health San Antonio MD Anderson Cancer...

Beactica Therapeutics AB, the Swedish precision oncology company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to BEA-17 for the treatment of glioblastoma (GBM). BEA-17 is a first-in-class small...

Dymicron today announced that it is launching an offering of securities through the use of an offering statement that has been qualified by the Securities and Exchange Commission....

Rise Therapeutics, a biopharmaceutical company engaged in developing novel oral synthetic biology medicines, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with...

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that...

Deka Biosciences ("Deka"), a biotech company focused on developing novel cytokine therapies to treat cancer and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has completed its review of the investigational...

The Menarini Group ("Menarini"), a leading Italian pharmaceutical and diagnostics company, announced today that...

HuidaGene Therapeutics (HuidaGene), a clinical-stage biotechnology company developing CRISPR-based programmable genomic medicine, announces that the US. Food and Drug...

Loxo@Lilly, the oncology unit of Eli Lilly and Company , today announced that the U.S....

The Cigar Association of America (CAA) today released an economic impact fact sheet about the Food and Drug Administration's (FDA) proposal to ban flavored cigars, showing the devastating effect it would have on the industry's sales and employment,...

DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing cell-based regenerative therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced the U.S. Food and Drug...

Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaimtm XR spinal cord stimulation (SCS) system to treat painful diabetic...

ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the prevention, diagnosis and treatment of allergies, announced that...

Fabre-Kramer Pharmaceuticals, a leading developer of novel small molecule medications to address unmet needs in the treatment of psychiatric and neurological disorders, announced today it received on January 20, 2023 acknowledgement and acceptance of...

AEYE Health, a leading AI company for retinal-based diagnostics, is pleased to announce the recent publication of its paper describing the development of a deep learning algorithm which can accurately predict the future development of diabetic...

tenacio, whose mission is to improve clinical outcomes for cardiovascular patients and to reduce healthcare costs, announced its OptiCor patient management platform is now commercially available in the...

icotec ag, the leading medical device manufacturer of Carbon/PEEK spinal implants, announces the U.S. Food and Drug Administration (FDA) 510(k) clearance to market the VADER® Pedicle System inclusive of Ø 4.5 mm pedicle screws and extended long...

BioVentrix®, Inc., a privately held medical device company focused on the development of less invasive therapies to directly treat the dilated left ventricle and reverse the left ventricular remodeling process of progressive heart failure, today...

Cadrenal Therapeutics , a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track...

Drugmaker Eli Lilly & Co announced today that the FDA has issued a complete response letter, meaning it has not granted accelerated approval for amyloid-clearing antibody donanemab. The FDA decision was due to the limited number of patients who...

The U.S. Food and Drug Administration (FDA) has accepted a supplemental...

Duality Biologics ("DualityBio"), a clinical-stage biotech company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers and autoimmune diseases, announced that the U.S. Food and Drug Administration...

Eli Lilly and Company today announced the U.S. Food and Drug Administration...

Mirati Therapeutics, Inc. , announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential first-in-class oral KRASG12D selective inhibitor for clinical evaluation....

Varian, a Siemens Healthineers company, announced today that the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) for the pivotal RADIATE-VTTM clinical trial. The RADIATE-VT trial will be the first...

Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, today announced that the U.S. Food and Drug...

USMG is now in 24-hour production, selling and shipping daily cartons of both its patient examination gloves and its 6-mil industrial general purpose nitrile gloves across these United States.US Medical...

Cyrano Therapeutics, a biopharmaceutical company developing medicines for patients with hyposmia (smell loss), announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CYR-064,...

Orthogen AG, a leader in molecular medicine, announces U.S. Food and Drug Administration (FDA) approval of an Investigational Device Exemption (IDE) for the company's proprietary technology, Orthogen® Device (OD). This approval allows the company to...

Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, today announced that the U.S. Patent and Trademark Office (USPTO) has granted a patent (Patent No. US 11,555,070)...

Abbott today announced that the U.S. Food and Drug Administration (FDA) has approved the company's...

Luye Pharma Group (Luye Pharma), an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications, today announced that the U.S. Food and Drug Administration (FDA) has approved Rykindo® (risperidone)...

Unicoeye, an online retailer of colored contact lenses, is entering the new year with the ambitious goal of accelerating its online expansion. The company is committed to achieving growth in 2023 and is taking the necessary steps to ensure this goal...

TJP Labs Inc. ("TJP Labs") is proud to announce the acceptance of its Premarket Tobacco Product Application (PMTA) submission by the U.S. Food and Drug Administration for its brand, L!X nicotine pouches. ...

The U.S. Food and Drug Administration (FDA) has approved a label update for Rybelsus® (semaglutide)...

Medcura, Inc., a medical device company dedicated to transformatively improving the management of surgical bleeding, announces that the U.S. Food and Drug Administration (FDA) has granted the coveted Breakthrough Device Designation for its LifeGeltm...

MTD Group ?a global leader in medical devices? today announced the FDA clearance obtained by its affiliate Pikdare S.p.A. for DropSafeTM SicuraTM passive safety needle for the intramuscular and subcutaneous injection of vaccines and other drugs....

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 coronary de novo lesions. This comes less than...

Medivir AB announced today that its partner Infex Therapeutics, a leading anti-infectives specialist, has been granted Qualified Infectious Disease Product (QIDP) designation for MET-X by the U.S. Food and Drug Administration (FDA). MET-X is the...

FDA's Fast Track designation for oral orismilast underscores the urgent need for new treatment options to fulfil the unmet medical need for people affected by moderate to severe hidradenitis suppurativa (HS)HS is a chronic, progressive, inflammatory,...

The U.S. Food and Drug Administration (FDA) has provided clearance for use of the ACL TightRope® II implant as the first-ever device for reconstructing torn knee ligaments in children and adolescents. The technology is based on a related device...

Theranica, a prescribed digital therapeutics company developing advanced neuromodulation devices for migraine and other pain conditions, today announced a strategic license and supply agreement with Dr. Reddy's Laboratories Ltd., a global...

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 coronary de novo lesions. This comes less than...

Innovative Sterilization Technologies (IST)/ONE TRAY® in Dayton, Ohio has announced that a Warning Letter issued in March 2019 by the U.S. Food and Drug Administration (FDA) has been closed. The FDA, as part of the warning letter review and...

Our company has now completed the certification process for our ISO 13485 #013671 and MDSAP #0136710, these certificates will allow Cellmyx to expand our distribution efforts worldwide. Cellmyx, one of the authorities on autologous adipose grafting...

Treadwell Therapeutics, a clinical-stage biotechnology company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-402257, a best in class inhibitor of Threonine Tyrosine Kinase (TTK, also known...

Arthrex, a global leader in minimally invasive surgical technology, announced today its ACL TightRope implant has received clearance from the U.S. Food and Drug Administration (FDA) for pediatric indications. The TightRope implant is used in the...

Lydus Medical is pleased to announce that the Vessealtm has received FDA clearance 510(k). The Vessealtm is a microvascular anastomosis suture deployment system, for standardized omni-vessel anastomoses, enabling simple, fast, safe, and effective...

Following a petition from Kellogg Company, the U.S. Food and Drug Administration (FDA) recently announced increases to the fortification levels of Vitamin D allowed within the cereal category and now allows fortification of Vitamin D in grain-based...