News by subject: FDA

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ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, received 510(k) clearance from the United States Food and Drug Administration (FDA) to commercialize its...

TransMedics Group, Inc. ("TransMedics") , a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart, and liver failure, today announced that the U.S. Food and Drug Administration (FDA) has...

NOCIRA®'s hand-held device that uses gentle, controlled puffs of air in the ears for treating migraine attacks is now designated by the FDA as a "Breakthrough Device." NOCIRA is the first company to announce FDA's Breakthrough Device designation for...

Treadwell Therapeutics, a clinical-stage biotechnology company developing novel medicines for unmet needs in cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to CFI-400945, a first in class...

Debiotech, a leading Swiss innovation company in the field of medical devices, announced today that the VersitmPD Cycler System, developed in close collaboration with its licensee Fresenius Medical Care, has received 510(k) clearance from the U.S....

Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV...

BIOTRONIK, Inc. announced today it has received U.S. Food and Drug Administration (FDA) approval of Renamic Neo, the company's state-of-the-art programmer for implanted cardiac rhythm management devices such as ICDs, pacemakers, and implantable...

X-Nav Technologies, LLC, a leading creator of image-guided and robot-assisted surgical products, announced that is has received clearance from the U.S. Food and Drug Administration to expand the use of its X-Guide® Dynamic Surgical Navigation system...

Today, the U.S. Food and Drug Administration expanded the approval of the COVID-19 treatment Veklury (remdesivir) to include pediatric patients 28 days of age and older weighing at least 3 kilograms (about 7 pounds) with positive results of direct...

CoNextions® Inc. (www.conextionsmed.com), an innovator in tendon repair, is pleased to announce that CoNextions TR® Tendon Repair System has received FDA 510(k) Clearance.  Expected to launch in May 2022, the novel system addresses traumatic tendon...

Priothera Ltd, 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 provided clearance to...

Ardelyx, Inc. , a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the Office of New Drugs (OND), Center for...

Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV...

Direct Biologics, a regenerative biotechnology company with a groundbreaking extracellular vesicle (EV) platform technology, announced today that the FDA has approved the company to proceed with its Phase 3 clinical trial using its investigational EV...

Nutrileads has...

Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted final approval of its Abbreviated New Drug Application for Miglustat Capsules (generic for Zavesca®), 100mg strength.  The product will be will...

NRx Pharmaceuticals, Inc. ("NRx Pharmaceuticals"), a...

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 US Food and Drug Administration (FDA)...

CMS I-neb® is an investigational treatment being developed as a potential first-in-class inhaled therapy for adult patients with NCFB colonized with P. aeruginosa; NCFB is a chronic, progressive, and irreversible respiratory diseaseBreakthrough...

Smallest, Lightest, and Quietest Peritoneal Dialysis Cycler Aims to Accelerate Adoption of Home Therapy WALTHAM, Mass., April 21,...

Today, ZEISS Medical Technology announced the U.S. Food and Drug Administration (FDA) has cleared the QUATERA® 700*, a revolution in phaco technology. It includes the ZEISS patented QUATTRO Pump® which delivers an exceptional level of chamber...

MicroGEM US Inc., a Virginia-based molecular biology company, has been granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, which provides polymerase chain reaction...

SMART Medical Systems Ltd., a developer and manufacturer of innovative endoscopy products, today announced an additional FDA clearance for its G-EYE® Colonoscope, based on Olympus' 510(k) cleared PCF colonoscope series. With this additional FDA...

BENDIT Technologies, a company focused on the development of a steerable microcatheter platform, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the neuro,...

Brand Institute is proud to announce its successful partnership with Amneal Pharmaceuticals in developing the brand name ALYMSYS®, under which the biosimilar approved by the Food and Drug Administration (FDA) on April 13, 2022 will be marketed. This...

BENDIT Technologies, a company focused on the development of a steerable microcatheter platform, announced today that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Bendit21 microcatheter for treatment in the neuro,...

On April 15th, SonoScape today announced that the U.S. Food and Drug Administration (FDA) has approved its flagship video endoscopy system HD-550 for gastrointestinal diagnosis, setting up a major milestone on SonoScape's Endoscopic product roadmap....

On April 15th, SonoScape today announced that the U.S. Food and Drug Administration (FDA) has approved its flagship video endoscopy system HD-550 for gastrointestinal diagnosis, setting up a major milestone on SonoScape's Endoscopic product roadmap....

Valneva's inactivated COVID-19 vaccine, VLA2001, including Albumedix´ Recombinant Human Albumin (rHA) as an essential component, received regulatory approval from MHRA on April 14th. This marks an expansion of the companies' existing collaboration...

Approval demonstrates the potential of Zilosultm to address an unmet medical need in OA which effects more than 72 million people in the US, EU5, and Canada KEY HIGHLIGHTS FDA Fast Track Designation for Pentosan Polysulfate Sodium (Zilosultm/PPS)...

Today, Alio Inc., announced it received FDA 510(k) clearance for its remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. Collected physiological data includes skin...

Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative...

Apotex Corp. announced today its release of Paclitaxel protein-bound particles for injection (albumin-bound), a generic version of Abraxane® in the United States. Paclitaxel protein-bound particles for injectable suspension is indicated for the...

Direct Biologics, an innovative biotechnology company with a groundbreaking extracellular vesicle (EV) platform drug technology, announced that the U.S. Food and Drug Administration (FDA) has awarded their EV drug product ExoFlo with a Regenerative...

The Food and Drug Administration (FDA) has given public access to its draft guidance entitled "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency"1....

MediLink Therapeutics announced that YL201, the first compound based on MediLink's proprietary antibody-drug conjugate (ADC) technology platform, has been cleared on its Investigational New Drug (IND) application by the U.S. Food and Drug...

Transit Scientific announced the FDA clearance of its XO Cross® Support Catheter Platform to include coronary use. The platform is indicated to guide and support a guidewire during access of the peripheral or coronary...

Aeglea BioTherapeutics, Inc. , a clinical-stage biotechnology company developing a new...

Keymed Biosciences (2162.HK) announced that its new drug candidate CMG901 (the "Claudin 18.2 antibody drug conjugates") for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma has been granted the Orphan-drug Designation by...

NeuroSense Therapeutics Ltd. ("NeuroSense"), a company developing treatments for severe neurodegenerative diseases, today announced that it has enrolled and dosed the first healthy volunteer in its pharmacokinetic (PK) study (NCT05232461) of its...

Israeli startup Sanolla, which provides AI-powered primary care diagnostic solutions, announced that the FDA has granted 510(k) clearance for the clinical use of...

Proof Diagnostics, Inc., an innovative healthcare technology company delivering innovative solutions in molecular diagnostics, today announced the submission of its Emergency Use Authorization (EUA) request for review to the U.S. Food and Drug...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the United States Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG (serplulimab) for the treatment of small cell lung cancer (SCLC). This is the first...

Clayton Pharmaceuticals, a thought leader and pioneer in developing innovative pathways to establish bioequivalence for complex generic drug products, announces that they have received FDA approval for Sucralfate Oral Suspension with Competitive...

Avet Pharmaceuticals Inc. announced today the U.S. launch of its Propofol Injectable Emulsion, USP 10 mg/mL, in 20, 50 and 100 ml Single Patient-Use Vials, an AB rated generic equivalent of DIPRIVAN® (propofol) Injectable Emulsion USP, following its...

Aidoc, the leading provider of healthcare AI solutions, announced today that it received its 9th FDA 510(k) clearance for triage and notification of brain aneurysm. This announcement further strengthens Aidoc's position as the leading provider of the...

Peregrine Ventures, a leading investment firm dedicated to supporting life changing healthcare opportunities, today realized the USD 500 million exit from CartiHeal (USD 350 million down payment plus an additional USD 150 million milestone). This...

Escala Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) , announced today that it received regulatory clearance from the United States Food and Drug Administration (FDA) for its first pelvic organ prolapse...

BiOneCure Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the IND for BIO-106, an antibody-drug conjugate (ADC) designed to target TROP-2 to treat a broad range of advanced solid tumors....