Le Lézard

News by subject: FDA

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13 december 2019

18:14
Amarin Corporation plc today announced that the U.S. Food and Drug Administration (FDA) has approved a new indication and label expansion for VASCEPA® (icosapent ethyl) capsules. After more than a decade of development and testing, VASCEPA is now...

16:37
The U.S. Food and Drug Administration today approved the use of Vascepa (icosapent ethyl) as an adjunctive (secondary) therapy to reduce the risk of cardiovascular events among adults with elevated triglyceride levels (a type of fat in the blood) of...

16:00
The Muscular Dystrophy Association (MDA) today celebrated the decision by the US Food and Drug Administration (FDA) to grant accelerated marketing approval to golodirsen (Vyondys 53) for the treatment of Duchenne muscular dystrophy (DMD) in patients...

14:07
ITF Pharma, a U.S.-based specialty pharmaceutical company and subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved its application to...


12 december 2019

17:44
The U.S. Food and Drug Administration today granted accelerated approval to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53...

12:35
Today, the U.S. Food and Drug Administration authorized marketing of the first test to aid in newborn screening for Duchenne Muscular Dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness. ...

07:00
Provention Bio, Inc. , a clinical stage biopharmaceutical company dedicated to intercepting and preventing immune-mediated diseases, today announced that it completed a Type B multidisciplinary meeting with the U.S. Food and Drug Administration (FDA)...


11 december 2019

16:10
ImpediMed Limited , a medical software technology company that non-invasively measures, monitors and manages fluid status and tissue composition using bioimpedance spectroscopy (BIS), recently announced the issuance of a further 510(k) clearance for...

08:00
Cochlear Limited , the global leader in implantable hearing solutions, announces today the U.S. Food and Drug Administration (FDA) clearance of the new Cochleartm Osia® 2 System. The Osia System is the world's first active osseointegrated...


10 december 2019

16:38
Correvio Pharma Corp. , a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that the U.S. Food and Drug Administration (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) met to review the...

09:17
Global Institute of Stem Cell Therapy and Research (GIOSTAR), the leader in regenerative technologies, is proud to announce that they are in the process of approval from the United States Food and Drug Administration (FDA) to conduct type 2 diabetes...

08:53
OrthoGrid Systems, Inc., a global medtech leader in alignment technology for orthopedic surgery, announces today that its newest application, PhantomMSK Trauma, has received 510(K) clearance from the U.S. Food and Drug Administration (FDA)....

08:30
VistaGen Therapeutics, Inc. , a clinical-stage biopharmaceutical company developing new generation medicines for central nervous system (CNS) diseases and disorders with high unmet need, today announced that the U.S. Food and Drug Administration...

07:05
Correvio Pharma Corp. , a specialty pharmaceutical company focused on commercializing hospital drugs, today announced that NASDAQ and the Toronto Stock Exchange have halted trading of the Company's common stock.  The U.S. Food and Drug...

06:58
Shoulder Innovations, (SI), a leading innovator in the development of shoulder replacement systems, announced today that they have received FDA clearance for their InSet Plustm augmented glenoids for the InSettm Total Shoulder System....


9 december 2019

12:13
LimaCorporate is pleased to announce the FDA 510K approval for Smart SPACE Shoulder 3D Planner & 3D Positioner. Smart SPACE is an innovative digital platform developed by TechMah Medical thanks to collaboration with LimaCorporate, who entered into a...


7 december 2019

07:33
AbbVie , a research-based global biopharmaceutical company, today announced results from an extended follow-up analysis of the Phase 3 E1912 clinical study ? designed and conducted by the ECOG-ACRIN Cancer Research Group (ECOG-ACRIN) and sponsored by...


6 december 2019

14:31
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLAtm (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid...


5 december 2019

15:29
The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. "Approving safe...

06:00
MolecuLight Inc., the world's leader in handheld fluorescence imaging for real-time visualization of fluorescence in wounds, has received FDA 510(k) clearance for its i:X® handheld fluorescence imaging device for use in the detection of wounds...


4 december 2019

06:16
APR Applied Pharma Research sa ("APR"), the Swiss pharma company focused in niche and rare therapeutic areas, announces that the US Food and Drug Administration (the "FDA") has granted Orphan Drug Designation for its investigational drug code-named...


3 december 2019

09:00
Johnson & Johnson Vision*, a global leader in eye health, today announced the Food and Drug Administration (FDA) approval and U.S. launch of TECNIS Toric II 1-Piece Intraocular Lens (IOL). This is the first product approved on the new TECNIS Toric II...

08:00
RightEye LLC, an award-winning health technology company that uses eye-tracking technology to help diagnose and monitor health and vision issues, today announced that the RightEye Vision System has received Breakthrough Device Designation from the...

07:05
LUTRONIC, a leading developer of intelligent energy-based medical devices, will unveil the new LaseMD ULTRAtm this week, during live patient demonstrations at the Cosmetic Surgery Forum in Nashville, Tennessee. "Lutronic's new LaseMD ULTRA is an...


2 december 2019

10:00
Breckenridge Pharmaceutical, Inc. announced today that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Rivastigmine Transdermal System in 4.6mg/24 hours, 9.5mg/24 hours and 13.3mg/24 hours...

08:00
Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., one of the world's leading companies in the diagnostic imaging business, announced today that its contrast agent LUMASON is the first ultrasound enhancing agent (UEA) to obtain...

08:00
Cumberland Pharmaceuticals Inc. , a specialty pharmaceutical company, today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for RediTrextm, its new line of methotrexate products....


1 december 2019

19:00
Innovent Biologics, Inc. ("Innovent" or "the Company") (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, autoimmune, metabolic and other major diseases, today...


26 november 2019

07:30
Evofem Biosciences, Inc. , a clinical-stage biopharmaceutical company, today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Amphora®, a Multipurpose Vaginal pH Regulator (MVP-Rtm),...


25 november 2019

18:00
The U.S. Food and Drug Administration today approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media). The Tubes Under...

16:03
Kindred Biosciences, Inc. , a biopharmaceutical company focused on saving and improving the lives of pets, today announced that the U.S. Food and Drug Administration's Center for Veterinary Medicine has approved Zimetatm (dipyrone injection) for the...

15:29
Today, the U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. "Today's...


21 november 2019

18:10
SK Biopharmaceuticals, Co., Ltd., an innovative global pharmaceutical company focused on developing and bringing treatments to market for central nervous system (CNS) disorders, and its U.S. subsidiary SK Life Science, Inc. announced today that the...

17:14
The U.S. Food and Drug Administration today approved XCOPRI (cenobamate tablets) to treat partial-onset seizures in adults. "XCOPRI is a new option to treat adults with partial-onset seizures, which is an often...

15:31
IRRAS, a global healthcare company with a comprehensive portfolio of innovative products for neurocritical care, announced today that the US FDA has cleared a new 510(K) for IRRAflow. The application provided the FDA with supporting data...

10:48
Today, as part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration (TGA) and Health Canada, the U.S. Food and Drug Administration granted supplemental approval to Calquence (acalabrutinib) for the treatment of...

10:13
MCRA, LLC (www.mcra.com) is pleased to announce that its client THINK Surgical, Inc. has obtained clearance from the U.S. Food and Drug Administration (FDA) to market the TSolution One® Total Knee Application for use in total knee arthroplasty (TKA)...

08:33
NuVasive, Inc. , the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the Company received U.S. Food and Drug Administration (FDA) 510(k)...

08:01
60 Degrees Pharmaceuticals (60P) has initiated distribution of Arakodatm (tafenoquine) into the US healthcare marketplace. This significant milestone complements the regulatory approval of Arakodatm by the United States Food and Drug Administration...


20 november 2019

13:21
Today, the U.S. Food and Drug Administration granted approval to Givlaari (givosiran) for the treatment of adult patients with acute hepatic porphyria, a genetic disorder resulting in the buildup of toxic porphyrin molecules which are formed during...

08:00
Q BioMed Inc. ,  announces FDA approval of its contract manufacturer IsoTherapeutics Group LLC (ITG). ITG is now cleared to manufacture the Company's FDA approved non-opioid cancer bone pain drug Strontium-89 Chloride USP. The long-awaited approval...


18 november 2019

16:59
Accord Healthcare Limited ("Accord") and ADIENNE Pharma & Biotech S.A. ("ADIENNE") have entered into an exclusive licencing and distribution agreement for the commercialisation of TEPADINA® (thiotepa) 15mg and 100mg lyophilized powder for injections....

11:46
Novartis has announced that the U.S. Food and Drug Administration approved its new drug to treat sickle cell disease. The therapy, known as Adakveo, is based on discoveries made by Oklahoma Medical Research Foundation physician-scientist Rodger...

10:34
Cerapedics, a private ortho-biologics company, today announced the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and...

08:30
CooperVision announced today it has received U.S. Food and Drug Administration (FDA) approval of its innovative MiSight® 1 day contact lens1. The cornerstone of a comprehensive myopia management approach to be offered by CooperVision, this daily...

08:00
Levo Therapeutics, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for LV-101 (intranasal carbetocin) for the treatment of Prader-Willi syndrome (PWS). Levo is currently enrolling participants...

06:50
Protalix BioTherapeutics, Inc.  , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and its...


15 november 2019

18:58
Biological products play an increasingly central role in modern medicine, offering treatments for many serious illnesses. Commonly referred to as biologics, these medicines are generally made from natural or living sources, like animal and plant...

17:29
The U.S. Food and Drug Administration today approved the first contact lens indicated to slow the progression of myopia (nearsightedness) in children between the ages of 8 and 12 years old at the initiation of treatment. The MiSight contact lens is a...

16:32
Novartis announced today that the US Food and Drug Administration (FDA) approved Adakveo® (crizanlizumab-tmca), previously known as SEG101, to reduce the frequency of vaso-occlusive crises (VOCs), or pain crises, in adult and pediatric patients aged...

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