News by subject: 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...

Servier, a leader in oncology committed to bringing the promise of tomorrow to the patients we serve, today announced that the U.S. Food...

Elevation Oncology, Inc. , a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast...

Kendamil is in advanced discussions with the FDA to become the first international manufacturer to export significant quantities of non-medicated infant formula to the USA under Joe Biden's 'Operation Fly Formula' to address the ongoing formula...

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inHEART, a privately-held medical device company delivering the world's most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance for its inHEART MODELS software suite that enables 3D visualization and...

Blue Lake Biotechnology, Inc., a clinical-stage biopharmaceutical company developing vaccines using a proprietary transformational parainfluenza virus 5 (PIV5)-based vector, today announced that the U.S. Food and Drug Administration (FDA) has granted...

Dupixent is the first and only medicine indicated to treat eosinophilic esophagitis in the United States; approval granted more than two months ahead of FDA's Priority Review action date Dupixent 300 mg weekly significantly improved signs and...

Today, the U.S. Food and Drug Administration approved Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in adults and pediatric patients 12 years and older weighing at least 40 kilograms (which is about 88 pounds). Today's action marks the...

Today the U.S. Food and Drug Administration (FDA) granted the Flexible Vinyl Alliance's (FVA) petition to abandon the use of 25 ortho-phthalate substances. These substances are no longer used in the manufacture of food packaging and other...

BONESUPPORT tm, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company has received market authorization from the US Food and Drug Administration (FDA), for the company's antibiotic eluting product...

Cytovation ASA, a clinical stage immune-oncology company focused on the development of CyPep-1, its first-in-class targeted tumor membrane immunotherapy, announces that its investigational new drug (IND) application for CyPep-1 has been accepted by...