News by subject: FDA

Sirnaomics Ltd. ("Sirnaomics", stock code: 2257.HK), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, announced the peer-reviewed publication of Phase IIa clinical study results of its lead therapeutic candidate,...

VisAR, an augmented reality surgical navigation system from healthcare technology leader Novaradtm, receives FDA 510(k) approval for precision guided intraoperative spine surgery. VisAR transforms a patient's imaging data into a 3-dimensional...

Ricoh USA, Inc. today announced RICOH 3D for Healthcare has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its craniomaxillofacial (CMF) and orthopedic patient-specific anatomic modeling....

Sysmex America, Inc., a leading diagnostic solutions company offering hematology, urinalysis, information systems and flow cytometry testing technology for optimal clinical laboratory performance, has received FDA clearance for the addition of...

Kintara Therapeutics, Inc. ("Kintara" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, today announced that the United States Food and Drug Administration (FDA) has granted Fast Track...

Phanes Therapeutics, Inc. (Phanes), an emerging leader in innovative discovery research and clinical development in oncology announced today that it has received clearance from the US Food and Drug Administration to commence Phase I studies with...

Cellenkos, Inc., a privately held, clinical stage biotech company that focuses on developing transformative T regulatory cell therapies for rare inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its...

Eli Lilly and Company and Incyte announced today that the U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib), a once-daily pill, as a first-in-disease systemic treatment for adults with severe alopecia areata (AA),...

Today, the U.S. Food and Drug Administration approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each...

Nammi Therapeutics, Inc. (Nammi), an LA-based immunotherapy company, announced today that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its lead program, QXL138AM, for the treatment of multiple myeloma....

Rune Labs, a precision neurology company, today announced its StrivePD software ecosystem for Parkinson's disease has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA)...

Pharmascience International, a division of Pharmascience Inc. is proud to launch Bortezomib for Injection 3.5 mg per vial (Lyo) in the United States as of May 2, 2022, with our local partner....

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...

Lipogems is pleased to announce the unconditional approval by the U.S. Food and Drug Administration (FDA) to conduct an Investigational Device Exemption (IDE) study for treatment of knee osteoarthritis (OA) compared to corticosteroids for a period of...

Scopio Labs, a medtech company that develops AI-powered diagnostic platforms for earlier and more accurate detection of cancers, infections, and other diseases, announced today that its ground-breaking X100HT device with Peripheral Blood Smear (PBS)...

Qpatch is a state-of-the-art wearable device for measuring individual ECG signal to obtain accurate cardiac arrhythmia diagnosis across many days. It allows ECG monitoring sessions, lasting up to 15 days, for a single patient....

ResVita Bio, a cellular therapies startup, announces that the FDA has granted Rare Pediatric Disease Designation to RVB-001 to treat Netherton Syndrome, a chronic and life-threatening genetic skin disease. "The physical and emotional challenges of...

Alpha Tau Medical Ltd. , ("Alpha Tau" or the "Company"), the developer of the innovative alpha-radiation cancer therapy Alpha DaRTtm, announced today that the U.S. Food and Drug Administration (FDA) has conditionally approved the Company's...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious...

Children treated with Dupixent and topical corticosteroids (TCS) achieved clearer skin, experienced significantly improved overall disease severity and significantly reduced itch compared to TCS alone at week 16 in a Phase 3 trial Long-term safety...

Prapela, Inc. has submitted its unique bassinet pad for FDA clearance as a complementary treatment for newborns suffering from opioid withdrawal. Approval would make Prapela's product the...

Okami Medical Inc., a medical device company focused on developing innovative solutions that address key unmet clinical needs in peripheral vascular intervention, today announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the LOBO-7...

Microbion Corporation of Bozeman, MT, today announced that it has received non-dilutive funding through its strategic partnership with CUBRC, Inc., a Buffalo-based, independent not-for-profit research company, of up to $2.1 million from the US Navy...

iNtRON Biotechnology ("iNtRON" or "Company") announced today that the company has successfully completed the GLP toxicology studies of BAL200. The company has completed the general GLP toxicology and safety pharmacology studies with final test...

Valencia Technologies Corporation, a privately held company, today announced that it has completed the world's first commercial implantation of eCoin® in Sarasota, FL. The surgery was performed by Dr. Kristie Greene, a leader in the female pelvic...

Clarity Pharmaceuticals...

Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved RIABNItm (rituximab-arrx), a biosimilar to Rituxan®, in combination with methotrexate for adults with moderate to severely active rheumatoid arthritis (RA) who have...

Genesis Innovation Group's cultivate(MD) Capital Funds LP, funds that are focused on investments into early-stage healthcare companies with innovative technologies, announced today that one of their portfolio companies, Norfolk, VA based Embody, Inc....

Galderma announced today the availability of EPSOLAY (benzoyl peroxide) Cream, 5% in the U.S. following approval by the U.S. Food and Drug Administration (FDA) on April 22, 2022. EPSOLAY Cream is the first and only microencapsulated benzoyl peroxide...

Net Health, a provider of specialty electronic healthcare record (EHR) and predictive analytics software, announced today that Tissue Analytics, the company's AI-powered wound imaging and analysis software, has been granted Breakthrough Device Status...

Peace Out Skincare, a cult-favorite and leader in innovative skincare treatments, today announced the brand is now "Clean at Sephora" thanks to its creation of the first-ever clean, FDA approved over-the-counter hydrocolloid acne patch....

Insightec, a global healthcare company dedicated to using focused ultrasound to transform patient care, today announced the appointment of Dr. Omar Ishrak to the Insightec Board of Directors. Ishrak, widely recognized as a global visionary and...

Saneso Inc., a leading US developer of next gen endoscope systems announces today the US Food and Drug Administration (FDA) has granted 510(k) clearance of its novel integrated 360° field of view colonoscope.   "We are...

Codagenix Inc., a clinical-stage synthetic biology company with a rational virus design platform for viral vaccines and immuno-oncology therapeutics, today announced that the U.S. Food and Drug...

Efanesoctocog alfa is the first factor VIII therapy to be awarded Breakthrough Therapy designation by the FDA Designation is based on XTEND-1 phase 3 study data demonstrating a clinically meaningful prevention of bleeds and superiority in prevention...

P H & S Products, LLC has been awarded by the FDA a 510(k) medical device Class I listing for a two-tone single-use only, examination grade glove for protection against fentanyl, heroin, and gastric acid per the ASTM D6978-05 standard. Using these...

Mezzion Pharma Co., Ltd. (Mezzion Pharma) met with the FDA Division of Cardiology and Nephrology (DCN) on Friday, May 27th to discuss with the FDA the path forward for the regulatory approval of udenafil for the treatment of single ventricle heart...

Embody, Inc., a privately-held medical device company focused on soft tissue healing, announced today that it has received 510(k) clearances from the Food and Drug Administration (FDA) for its TAPESTRY RC System for the treatment of rotator cuff...

Abbott  today announced the U.S. Food and Drug Administration (FDA)...

Avillion LLP, a drug development company focused on the co-development and financing of pharmaceutical...

Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for...

Priothera, a late-clinical stage biotechnology company pioneering the development of its S1P receptor modulator compound, mocravimod, today announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) for...

Dupixent would be the first and only medicine specifically indicated to treat prurigo nodularis in the U.S., if approved Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has accepted for...

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted "breakthrough...

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted "breakthrough...

The SELUTION SLR (Sustained Limus Release) is a novel sirolimus-eluting balloon that provides a controlled sustained drug release, similar to a drug-eluting stent (DES). SELUTION SLR was also the first DEB (Drug Eluting Balloon) granted "breakthrough...

Brand Institute is proud to announce working with Mitsubishi Tanabe in developing the brand name Radicava ORS®, approved by the Food and Drug Administration (FDA) on May 12, 2022.  FDA approved Radicava ORS (edaravone) oral suspension for the...

ManaMed (ManaMed.com) is proud to announce the U.S. Food and Drug Administration (FDA) approval for the ManaSporttm ultrasound therapy Class II device. The ManaSport device, is a new ultrasound therapy device that provides pain relief and treatment...

Perrigo Company plc , a leading provider of Consumer Self-Care Products, today announced that it has received final approval from the U.S. Food and Drug Administration for Omeprazole Magnesium Delayed-Release Mini Capsules, 20 mg over-the-counter ....

In the news release, Blue Lake Biotechnology Announces FDA Fast Track Designation for BLB-201 Intranasal RSV Vaccine, issued 24-May-2022 by Blue Lake Biotechnology, Inc. over PR Newswire, the dateline city should read "ATHENS, Ga." rather than...