Le Lézard

News by subject: FDA

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24 september 2019

08:00
CarboFix has announced today that the U.S. Food and Drug Administration (FDA) has cleared its CarboClear® Carbon Fiber Fenestrated Pedicle Screw System used in the treatment of patients with advanced stage spinal tumors....

07:00
Emmaus Life Sciences, Inc. , a leader in sickle cell disease (SCD) treatment, today released the following summary review of the clinical trials and efficacy findings for Endari®. "In light of our decision to withdraw our marketing authorization...


23 september 2019

08:00
Phoenix Molecular Designs (PhoenixMD), a clinical stage biotechnology company developing precise cancer therapeutics targeting essential kinases, received clearance from the Food and Drug Administration (FDA) for PhoenixMD's Investigational New Drug...

05:45
Exact Sciences Corp. announced today that the U.S. Food and Drug Administration (FDA) approved its noninvasive colorectal cancer screening test, Cologuard, for eligible average-risk individuals ages 45 and older, expanding on its previous indication...


20 september 2019

10:49
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has approved Rybelsus® (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar (glucose).1...

10:42
The U.S. Food and Drug Administration today approved Rybelsus (semaglutide) oral tablets to improve control of blood sugar in adult patients with type 2 diabetes, along with diet and exercise. Rybelsus is the first glucagon-like peptide (GLP-1)...

10:03
Hovione announced details of its planned MARS-2 and MARS-3 (Minocycline Against Rosacea Study) Phase 3 development program for the treatment of moderate to severe inflammatory rosacea. At a recent End-of-Phase 2 meeting with the U.S. Food and Drug...


18 september 2019

16:12
Louisiana Eye and Laser, home to ophthalmologists Dr. Michael Redmond and Dr. Patrick Redmond, performed the first PanOptix Lens replacement surgeries in cataract patients in the central and northern Louisiana regions last week. This advanced...

11:00
Oculo is pleased to announce its FDA registration and HIPAA compliance. The Oculo® system is a web-enabled platform that addresses the global problems of data silos and disconnected clinical communication in healthcare. The cloud-based Oculo...

08:00
OrthoSpin 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 smart, robotic external fixation...

08:00
Sound Pharmaceuticals is pleased to announce that the FDA's Division of Neurology Products has granted its request for Fast Track Designation (FTD) involving SPI-1005 in the treatment of Meniere's Disease (MD). FTD applies to serious conditions where...


17 september 2019

20:29
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved ERLEADA® (apalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer...


16 september 2019

09:00
Sofwave Medical Ltd., an emerging aesthetic device company, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Sofwave system. The Sofwave device is indicated for use as a non-invasive aesthetic...

08:40
Muskoka Grown Limited ("Muskoka Grown" or the "Company") proudly announces that it has received two updates from Health Canada; its sales amendment allowing for the distribution of dried cannabis products to authorized provincial distributors and...

08:00
Seattle Genetics, Inc. and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for the...

08:00
Glenmark Pharmaceuticals (Glenmark), a research-led, integrated global pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the...

07:10
DreaMed Diabetes, developer of personalized diabetes management solutions, announced today that it has received U.S Food and Drug Administration (FDA) clearance as well as CE Mark for DreaMed Advisor Pro, an artificial intelligence (AI)-based insulin...

07:00
Zimmer Biomet Holdings, Inc. , a global leader in musculoskeletal healthcare, has announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the JuggerStitchtm meniscal repair device. The JuggerStitch device is the next...


12 september 2019

16:37
Qfix has received FDA 510(k) clearance for the Encompass 15-Channel Head Coil, a diagnostic imaging device optimized for use with the Encompasstm MR SRS Immobilization Device.  The Encompass 15-Channel Head Coil provides diagnostic quality images...

15:13
Ardelyx, Inc. , a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that the U.S. Food and Drug Administration has approved...

13:44
LaunchPad Medical, Inc. has received approval from the U.S. Food and Drug Administration to initiate a two-site, 20-patient pilot clinical study to examine the safety and efficacy of the company's bone adhesive biomaterial (known as Tetranite®) to...

12:00
3D Systems announced today it received additional 510(k) clearance for its D2Ptm (DICOM-to-PRINT) software allowing clinicians to 3D print diagnostic patient-specific anatomic models. 3D Systems is the only company to offer a solution that combines...

10:16
V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation ? the first...

00:05
Today, Healthy.io, the global leader in turning the smartphone camera into a clinical-grade medical device, announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its smartphone-based ACR test to be used in...


11 september 2019

09:00
With recent regulatory changes to state and national laws, cannabis is undergoing a period of rediscovery and attraction from big pharma, nutraceutical manufacturers, food companies, and retailers. Chronic CBD users represent 7 percent of the...

02:30
Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough...


10 september 2019

17:29
Almirall LLC announced today the FDA approval of the expanded indication for Aczone® 7.5% Gel to include patients aged 9-11. Aczone® 7.5% Gel is a prescription medicine used on the skin (topical) to treat inflammatory and non-inflammatory acne,...


9 september 2019

15:56
Ophthalmological surgeons Tyrie Jenkins, M.D. and Jeffrey Peterson, M.D., Ph.D., of Jenkins Eye Care, now offer cataract patients a trifocal lens that provides a combination of near, intermediate and distance vision. This lens is also an option for...

13:44
The ANSI National Accreditation Board (ANAB), a wholly-owned subsidiary of the American National Standards Institute, has accredited Global Standards S.C. (GSSC) in accordance with the international standard, ISO/IEC 17065, Conformity...

08:36
Leading biomedical test-instrument manufacturer Netech announced today the launch of its new state-of-the-art defibrillator/pacemaker analyzer?the Delta 3300. Recently approved by the FDA 510(k), the Delta 3300 is a precision instrument for testing...

08:00
Boehringer Ingelheim today announced that the U.S. Food and Drug Administration (FDA) approved Ofev® (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated...

07:30
Allergan plc , a leading global pharmaceutical company with a heritage of more than 70 years in eye care, and Molecular Partners (SIX: MOLN), a clinical-stage biotechnology company developing a new class of drugs known as DARPin® platform, today...


6 september 2019

15:25
The U.S. Food and Drug Administration today approved Ofev (nintedanib) capsules to slow the rate of decline in pulmonary function in adults with interstitial lung disease associated with systemic sclerosis or scleroderma, called SSc-ILD. It is the...

06:36
WONTECH, a leading Korean medical device company, announced that its Holmium laser device, Holinwon Prima, received U.S. Food and Drug Administration approval. Holinwon Prima, approved by the FDA, is the first Holmium laser medical device developed...


5 september 2019

16:59
Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approvals for their generic versions of Decitabine and Fosaprepitant for injection.  Decitabine was approved on August 29th,...

11:09
Nichi-Iko Pharmaceutical Co., Ltd. ("Nichi-Iko") and Sagent Pharmaceuticals, Inc., a Nichi-Iko Group Company ("Sagent"), a leader of specialty pharmaceutical products with an emphasis on the injectable market, today announced that their Canadian...

10:15
VeraSci, a leading provider of innovative scientific and biotechnology services, announced today that they have received an FDA grant to conduct further research on the VRFCAT, their proprietary functional capacity assessment. The VRFCAT has recently...

09:18
Arthrosurface®, Inc., a global leader in joint preservation technology, recently received 501K clearance from the FDA for its BOSStm Toe Fixation System. This new product is intended to improve stabilization in a first metatarsal that presents with a...


4 september 2019

09:39
Cantargia AB today announced that a request for a pre-IND meeting with the US FDA has been submitted. The purpose of the meeting is to discuss the current documentation on the antibody CAN04 and a proposed new phase I clinical combination study with...

09:30
Prescient Metabiomics, a privately held company and a subsidiary of Prescient Medicine Holdings, Inc., announced that the U.S. Food and Drug Administration (FDA) has granted the company's submission for Breakthrough Device designation to its...

07:30
Endo International plc  today announced that Novitium Pharma, LLC, a partner of Endo's subsidiary Endo Ventures Limited, received approval from the U.S. Food and Drug Administration for a room temperature stable, AB-rated, generic equivalent of...


3 september 2019

07:30
Allergan plc announced today it received U.S. Food and Drug Administration (FDA) approval for the use of Juvéderm VOLUMA® XC, a hyaluronic acid gel dermal filler, with a TSK STERiGLIDEtm cannula for cheek augmentation to correct age-related volume...

01:20
Calliditas Therapeutics AB (publ) ("Calliditas") today announced that it has obtained written feedback from the US Food and Drug Administration (FDA) that will have a significant impact on the ongoing pivotal Phase 3 study, NefIgArd, with Calliditas'...


30 august 2019

22:54
CARsgen Therapeutics Inc., a clinical-stage biopharmaceutical company today announced the United States Food and Drug Administration (FDA) has granted orphan drug designation to its investigational CAR-T cell therapy fully human anti-BCMA (B Cell...

12:48
Jeffrey D. Horn, MD, owner of Vision For Life in Nashville, is set to be the first to surgically implant the new FDA approved PanOptix Trifocal Intraocular Lens on Wednesday, Sept. 4, and you are invited to the procedure and interview the surgeon and...


29 august 2019

16:39
The FDA received Concept Medical Inc. (CMI) request to designate MagicTouch AVF as a Breakthrough Device in July 2019. The proposed...


28 august 2019

13:42
4WEB Medical, an orthopedic device company focused on developing innovative implants utilizing its proprietary Truss Implant Technologytm, announced today that the company has received 510(k) clearance from the U.S. Food and Drug Administration...

07:59
Bone Solutions Inc., announces a private label licensing agreement with Onkos Surgical covering OsteoCrete® technology ? the first FDA (510k) cleared magnesium-based bone void filler in the orthopedic marketplace, designed to assist with bone repair...

06:52
Lannett Company, Inc. today announced that it has entered into an agreement with Sinotherapeutics Inc., a China-based specialty pharmaceutical company, to be the exclusive U.S. distributor of Posaconazole Delayed-Release Tablets 100mg. ...


27 august 2019

17:02
The U.S. Food and Drug Administration today approved Nourianz (istradefylline) tablets as an add-on treatment to levodopa/carbidopa in adult patients with Parkinson's disease (PD) experiencing "off" episodes. An "off" episode is a time when a...

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