Le Lézard

News by subject: FDA

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21 march 2019

14:50
Impulse Dynamics, developer of the implantable Optimizer® Smart System for delivering CCMtm therapy, announced today that it has received approval from the United States Food and Drug Administration for its first-in-class Optimizer Smart System (link...

13:18
The U.S. Food and Drug Administration today approved the Optimizer Smart system for treating patients with chronic, moderate-to-severe heart failure who are not suited for treatment with other heart failure devices such as cardiac resynchronization...

08:33
GenePOC Inc., member of the Debiopharm Group, announces its third test to be cleared by the FDA, the GenePOC Strep A assay, to be used with the revogenetm device. About Group A Streptococcus (GAS) infection GAS is the most common bacterial etiology...

08:00
Beckman Coulter, a global leader in clinical diagnostics, announced today that its DxH 520 hematology analyzer has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), and is now available for sale in the United States....

07:00
Enzyvant, a biopharmaceutical company focused on developing and commercializing transformative therapies for patients with rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease and Fast...


20 march 2019

18:53
Jazz Pharmaceuticals plc today announced that the U.S. Food and Drug Administration (FDA) approved Sunositm (solriamfetol) to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep...


19 march 2019

09:30
We all know the FDA is the arm of the U.S. government that, among other things, controls and oversees the approval process for medical device products and technologies are used in the diagnosis, prevention and treatment of diseases. It is estimated...

08:00
Soliton, Inc., ("Soliton" or the "Company"), a medical device company with a novel and proprietary platform technology licensed from The University of Texas on behalf of the MD Anderson Cancer Center ("MD Anderson"), completed the human trials of...

07:30
Today, Atreon Orthopedics, a ParaGen Technologies subsidiary company that focuses on orthopedic products, announced that the U.S. Food and Drug Administration (FDA) has cleared its proprietary product, the RotiumTM Bioresorbable Wick, which supports...


18 march 2019

16:30
Perrigo Company plc a leading global provider of "Quality, Affordable, Self-Care Productstm" today announced it has received tentative approval from the U.S. Food and Drug Administration for the generic version of Finacea® Foam (azelaic acid) 15%. ...

08:42
Zyppah announces that after six years on the market, it has become the #1 marketed anti-snoring device and has been granted the necessary clearances by the FDA to be made available OTC (over-the-counter). As of January 21, 2019, Zyppah and its...

07:30
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for AVYCAZ® (ceftazidime and avibactam), expanding the label to include pediatric patients 3 months and...

07:00
Via Surgical Ltd, a leading developer of surgical fixation solutions, today announced U.S. Food and Drug Administration 510(k) clearance of the FasTouchtm Absorbable Fixation System. The FasTouchtm enables for the first time an automated lockable...


14 march 2019

16:52
The U.S. Food and Drug Administration today allowed marketing of a new device, ClearMate, intended to be used in an emergency room setting to help treat patients suffering from carbon monoxide poisoning. The device uses a novel method for quickly...

14:12
By age 22, Victor C. had tried everything in his battled against severe depression and was losing hope. Last year he found new hope with intravenous ketamine infusions.  Ketamine lifted his depression. "I felt reborn," he said. "There is no other way...

13:57
BIOTRONIK today announced FDA approval of the Acticor and Rivacor high-voltage cardiac rhythm management (CRM) device families for treatment of patients with cardiac arrhythmias. The six new tachycardia solutions include Rivacor VR-T, Rivacor DR-T,...

13:52
Abbott today announced it received approval from the U.S. Food and Drug Administration (FDA) for a new, expanded indication to its leading MitraCliptm device used to repair a leaky mitral valve without open-heart surgery. Supported by the results of...

10:59
The U.S. Food and Drug Administration today approved a new indication for a heart valve repair device that is intended to reduce moderate-to-severe or severe mitral regurgitation, a leakage of blood backward through the mitral valve into the heart's...

10:20
Pharmaceutics International, Inc. (Pii), a Contract Development and Manufacturing Organization (CDMO) today announced that the U.S. Food and Drug Administration (FDA) has issued their Establishment Inspection Reports (EIRs) for both FEI registration...

07:00
Organic food processors and food handlers in need of a surface sanitizer without quaternary ammonium (quat) now have an effective product for cleaning and sanitizing food contact and non-food contact surfaces in their facilities. Originally released...

06:59
BD (Becton, Dickinson and Company) , a leading global medical technology company, today announced the U.S. Food and Drug Administration has granted premarket approval for the Venovotm venous stent, the first stent indicated to treat iliofemoral...


12 march 2019

15:59
Hematogenix®- a global leader in the field of integrated pathology services for drug development and immuno-oncology testing, today announced the launch of the companion diagnostic test for the drug TECENTRIQ®. On March 8, 2019, the U.S. Food and...

15:34
Today, the U.S. Food and Drug Administration approved a new generic of Diovan (valsartan). Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. The FDA prioritized the review of this drug...

11:36
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is...


11 march 2019

15:44
Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation that underlies atopic dermatitis In a Phase 3 trial, Dupixent significantly reduced the extent and severity of disease and itching, and helped...

13:38
The federal Food & Drug Administration and the cosmetics industry must do a better job protecting consumers from harmful chemicals in cosmetic products ? including cancer-causing asbestos found in talc-based makeup and body powders, outgoing FDA...

09:30
Sonavex, Inc., a privately held medical device company focused on empowered patient care, announced today that on March 8, 2019 it received 510(k) clearance from the U.S. Food and Drug Administration for its EchoSure device to deliver definitive...

07:30
Allergan plc today announced that the U.S. Food and Drug Administration (FDA) has accepted the company's New Drug Application (NDA) for ubrogepant for the acute treatment of migraine in adults. The NDA filing is based on the successful completion of...


7 march 2019

20:00
ZEISS Medical Technology Segment of ZEISS announced that it has received 510(k) clearance from the FDA for the CIRRUS HD-OCT platform, expanding the capabilities of its Anterior Segment Premier Module to include Epithelial Thickness Mapping (ETM)....

14:00
Maxx Orthopedics, Inc. a subsidiary of Maxx Medical, Pvt. Ltd., a rapidly expanding global orthopedics device company, today announced that it has received US FDA clearance for its Freedom® Ultra-Congruent liner, the latest addition to its Freedom...

12:19
The FDA (The Food and Drug Administration) has issued a final order to classify Natural Cycles as a Class II device. The FDA is a federal agency in the United States (US) that is responsible for protecting and promoting public health. In August 2018,...


6 march 2019

08:33
Water Street Healthcare Partners, a strategic investor focused exclusively on the health care industry, announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration...

08:30
Instrumentation Laboratory (IL) today announced the 510(k) clearance of their latest innovation, the GEM Premier ChemSTAT in vitro diagnostic (IVD) analyzer with Intelligent Quality Management  (iQM®) by the US Food and Drug Administration (FDA).  A...

06:00
The Brain & Behavior Research Foundation (BBRF) applauds the FDA for its approval of Esketamine nasal spray as a new medication for treatment of resistant depression.  Dr. Jeffrey Borenstein, a Manhattan psychiatrist and...


5 march 2019

22:12
"New FDA approved depression treatment, esketamine, is the biggest advancement in depression treatment in thirty years" ? says Houston based Psychiatrist, Dr. Sandhya Prashad. This approval allows ketamine treatments to be more widely available and...

20:17
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the U.S. Food and Drug Administration (FDA) has approved SPRAVATOtm (esketamine) CIII nasal spray for use in conjunction with an oral antidepressant in adults with...

19:26
The U.S. Food and Drug Administration today approved Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, for the treatment of depression in adults who have tried other antidepressant medicines but have not benefited from...

14:56
NKMax America, a biotechnology company harnessing the power of the body's immune system through the development of Natural Killer (NK) cell therapies, announced today that the U.S. Food and Drug Administration (FDA) has accepted the Investigational...


4 march 2019

13:30
Breckenridge Pharmaceutical, Inc. announced that the U.S. Food and Drug Administration has granted final approval for its Abbreviated New Drug Application for Imatinib Mesylate Tablets, generic for Gleevec® Tablets by Novartis.  Breckenridge's...

10:38
FDA's approval of ketamine to address depression classified as 'treatment resistant' is a double-edged sword. "Ketamine is currently used as an anesthetic, but it is also an abusable, addictive street drug," commented Indra Cidambi, M.D., Addiction...


28 february 2019

11:47
Halozyme Therapeutics, Inc. , a biotechnology company developing novel oncology and drug-delivery therapies, today announced that Genentech, a member of the Roche Group, has received approval from the U.S. Food and Drug Administration (FDA) for...


27 february 2019

20:33
WuXi Biologics ("WuXi Bio") (Stock code: 2269.HK), a leading global open-access biologics technology platform company offering end-to-end solutions for biologics discovery, development and manufacturing, congratulates its strategic partner...

16:17
The U.S. Food and Drug Administration (FDA) has approved the expanded use of Soliqua® 100/33 (insulin glargine and lixisenatide injection) 100 Units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2...

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 Exemestane Tablets, 25mg, generic for Aromasin® Tablets by Pfizer.  Breckenridge's...

08:39
For many companies in the fledgling stem cell regenerative medicine industry, an FDA recall of the primary product it distributes may be the death knell for the business as other firms step in to fill the void left in the rapidly growing market....

08:33
eNeura, Inc., a privately held medical technology company, announced today that it has obtained a new 510(k) clearance from the U.S. Food and Drug Administration (FDA). This new marketing clearance expands the product indication of acute and...

08:03
IBSA Pharma Inc. announced that its Tirosint-SOL (levothyroxine sodium) oral solution is now available in the US market for the treatment of hypothyroidism and pituitary thyrotropin suppression. Tirosint-SOL is the first...

07:30
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque...


26 february 2019

16:05
Heron Therapeutics, Inc. , a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the U.S. Food and...

10:00
OrthoGrid Systems, Inc., a leading innovator in intraoperative surgical imaging, workflow efficiency and decision-making support in orthopedic surgery, today announced that the US Food & Drug Administration has granted a 510(k) clearance for the...

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