News by subject: FDA

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial hypertension (PAH,...

NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, announced today that it received its latest U.S. Food and Drug Administration 510(k)...

BioArctic AB's (publ) partner Eisai held several presentations at the Alzheimer's Association International Conference (AAIC) in Denver, Colorado July 26 to 30, 2021. The presentations included the latest data for the investigational anti-amyloid...

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 U.S. Food and Drug Administration (FDA) 510(k) clearance...

Ardelyx, Inc. , a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that it has received...

Next Frontier Brands, an international consumer packaged goods company with a focus on beverage and wellness products, along with its subsidiary TreeHouse Biosciencestm, today announced that TreeHouse Biosciencestm has launched a "THC Remediation...

The U.S. Food and Drug Administration (FDA) has cleared for clinical lab use a gene sequencing test designed by molecular pathologists at NYU Langone Health and its Laura and Isaac Perlmutter Cancer Center to guide treatment decisions for patients...

Dignitana, world leader in scalp cooling innovation, has signed with leading distributor B&Co Group to drive growth in the Benelux region. Based in Ghent, B&Co now becomes the exclusive provider of The DigniCap Scalp Cooling System in Belgium, The...

Allergan, an AbbVie company, today announced that the U.S. Food and Drug Administration (FDA) has approved a label expansion of BOTOX® to include eight new muscles for the treatment of upper limb spasticity in adults. The new muscles for treatment...

Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced today its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device designation from the U.S. Food and Drug...

VICO Therapeutics, a Leiden Bio Science Park, the Netherlands, based biotech company focusing on the development of RNA modulating therapies for rare neurological disorders, today announced that the Office of Orphan Products Development (OOPD) of the...

Viatris Inc. and Biocon Biologics Ltd. (a subsidiary of Biocon Ltd.) today announced that the U.S. Food and Drug Administration (FDA) has approved Semglee® (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the...

Transcenta Holding Limited ("Transcenta"), a clinical stage global biotherapeutics company with fully-integrated capabilities in discovery, development and manufacturing of antibody-based therapeutics, announces that the U.S. Food and Drug...

Fusion Pharmaceuticals Inc. , a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's...

Oncopeptides AB (publ) , a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announces that the US Food and Drug Administration, FDA, has issued a safety alert to patients and health...

MezLight LLC is excited to announce the launch of their revolutionary surgical lighting system to provide surgeons with a bright, sterile, and reusable solution for focused light....

Petros Pharmaceuticals, Inc. ("Petros," or "the Company"), a leading provider of therapeutics for men's health, today announces it has been granted a meeting with the U.S. Food and Drug Administration (FDA) to discuss expansions and modifications to...

Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, announced today that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug...

Cytrellis announces that the U.S. Food and Drug Administration has cleared their first proprietary product, the ellacor system with Micro-Coring technology, for the treatment of moderate to severe wrinkles in the mid to lower face. This...

LifeSignals Inc., today announced it has received FDA Class II 510 (k) approval for the LifeSignals LX1550 Multiparameter Remote Monitoring Platform. This follows recent CE marking and is further validation of LifeSignals' drive to create innovative...

Evren Technologies, Inc. announced today that its non-invasive Phoenix® earbud device received Breakthrough Device Designation from the U.S. Food and Drug Administration for the treatment of Post-traumatic Stress Disorder (PTSD)....

GlaxoSmithKline plc today announced that the US Food and Drug Administration (FDA) has approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of shingles (herpes zoster) in adults aged 18 years and older who are or who will be...

Inhibikase Therapeutics, Inc. ("Inhibikase" or "Company"), a clinical-stage pharmaceutical company developing therapeutics to modify the course of Parkinson's disease and related disorders, today announced that, after a review of safety,...

·         ONCOFID®-P is an innovative conjugation of the anticancer drug paclitaxel (taxol) with hyaluronic acid (HA). ·         Thanks to the HA component, ONCOFID®-P specifically binds cancer cells expressing CD44, the HA receptor, significantly...

SQI Diagnostics Inc. (the "Company" or "SQI") , a precision medicine company that discovers, develops and commercializes innovative rapid diagnostic testing for healthcare professionals, patients and consumers worldwide, announces that FDA will not...

AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in pediatric patients from birth. DALVANCE is the first...

USA News Group  -  Two of the world's most prominent billionaires, George Soros and Bill Gates, recently made headlines backing a consortium to buy UK Covid-19 test maker Mologic for $41 million ahead of a new initiative of a global rollout for rapid...

AnchorDx, a world-leading developer of cancer screening and early detection solutions, on July 13, 2021, was awarded a Breakthrough Device Designation ("BTD")[1] by the US Food and Drug Administration (FDA) for UriFind (or "the Test"), an early...

Viracta Therapeutics, Inc. , a precision oncology company targeting virus-associated malignancies, today announced that the U.S. Food and Drug Administration (FDA) has cleared Viracta's Investigational New Drug (IND) application to proceed into a...

Organicell Regenerative Medicine, Inc. , a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug...

AbbVie announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA®) in combination with azacitidine for the potential treatment of adult patients with previously...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") announced that the U.S. Food and Drug Administration (FDA) has approved its supplemental New Drug Application (sNDA) for PROGRAF® (tacrolimus) for the prevention...

First Light Diagnostics is developing and commercializing breakthrough automated diagnostic products for rapidly detecting infections and determining optimal treatment. The company announced today that the US Food and Drug Administration (FDA) has...

KeifeRx, LLC, an emerging clinical-stage biotechnology company specializing in the discovery and development of new treatment options for neurodegenerative diseases, announced today that the company received an acceptance of its Investigational New...

 Creative Medical Technology Holdings Inc. announced today the launching of its second Regenerative Immunology product, MyeloCelztm. ...

Ortho Regenerative Technologies Inc. ("Ortho" or the "Company"), a clinical stage orthobiologics company focused on the development of...

RedHill Biopharma Ltd. ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that OptumRx, part of the UnitedHealth Group - a leader in healthcare coverage, partnered with more than 1.3 million healthcare professionals...

Intravacc, a world leader in translational research and development of vaccines for...

Nevro Corp. , a global medical device company that is providing innovative, evidence-based solutions for the treatment of chronic pain, today announced receipt of FDA approval of its Senza® System for the treatment of chronic pain associated with...

Today, the U.S. Food and Drug Administration fully approved Tanovea (rabacfosadine injection) to treat lymphoma in dogs. Lymphoma, also called lymphosarcoma, is a type of cancer that can affect many species, including dogs. Tanovea is the first...

The American Association of Kidney Patients, the largest kidney patient consumer and caregiver organization in the nation, today issued the following statement regarding the recent approval by the U.S. Food and Drug Administration of a new drug...

The American Association of Kidney Patients, the largest kidney patient consumer and caregiver organization in the nation, today issued the following statement regarding the recent approval by the U.S. Food and Drug Administration of a new drug...

Direct Biologics, a market-leading innovator and cGMP manufacturer of regenerative biologic products, announced today that the U.S Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application to conduct a Phase I/II...

Tidal Medical Technologies today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for emergency use of the InSee incentive spirometer accessory for quantitatively tracking patient usage of Vyaire...

Ryvu Therapeutics (WSE: RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the U.S. Food and Drug Administration, FDA, has lifted a...

CoapTech, Inc, a medical device company focused on delivering transformative solutions for minimally-invasive surgery, announced today it has received CE Mark certification, as well as an approved CPT Procedure Code for its PUMA-G System, the world's...

Kintor Pharmaceutical Limited (HKEX:9939), a clinical-stage biotechnology company developing innovative small-molecule and biological therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has cleared an Investigational New...

East End Medical, a private medical device company committed to improving catheter-based cardiac procedures, today announced it received U.S. Food and Drug Administration (FDA) clearance for the company's SafeCrosstm Transseptal Radiofrequency (RF)...

Micron Biomedical, Inc. ("Micron" or the "Company"), a leader in dissolving, microneedle-based vaccine and drug delivery, today announced that it has initiated a Phase 1/2 clinical trial of its microneedle-based measles-rubella ("MR") vaccine. The...

Stryker announced today the FDA clearance of the first balloon implant for arthroscopic treatment of massive irreparable rotator cuff tears (MIRCTs)*. InSpace provides a new option for surgeons in their shoulder continuum of care that allows them to...