Le Lézard

News by subject: FDA

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Today

10:59
In a historic decision, the U.S. Food & Drug Administration authorized Swedish Match U.S. Division's amended Modified Risk Tobacco Product applications (MRTPAs) for eight varieties of General Snus, making it the first tobacco product to secure the...

09:10
Novo Nordisk today announced that the U.S. Food and Drug Administration (FDA) has expanded the label for Fiasp® (insulin aspart injection) 100 u/mL to include use in insulin infusion pumps for the improvement of glycemic control in adults with type 1...

08:36
BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for multiple cancer indications, today announces that the U.S. Food and Drug Administration (FDA) has approved Fast Track...

08:30
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...


21 october 2019

14:50
The U.S. Food and Drug Administration today approved Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy available to treat patients with the most common cystic fibrosis mutation. Trikafta is approved for patients 12...

08:00
Sophiris Bio Inc.  (the "Company" or "Sophiris"), a biopharmaceutical company studying topsalysin (PRX302), a first-in-class, pore-forming protein, in late-stage clinical trials for the treatment of patients with urological diseases, today announced...

07:58
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration's (FDA) approval of STELARA® (ustekinumab) for the treatment of adult patients with moderately to severely active ulcerative colitis. The...

06:00
United Therapeutics Corporation today announced that the U.S. Food and Drug Administration (FDA) has approved a supplement to the New Drug Application for Orenitram® (treprostinil) Extended-Release Tablets reflecting data from the FREEDOM-EV study...


18 october 2019

16:27
Foamix Pharmaceuticals Ltd.  ("Foamix" or the "Company"), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved its novel AMZEEQTM (minocycline) topical foam, 4%. AMZEEQ, formerly known as...

09:00
Amgen today announced that the U.S. Food and Drug Administration (FDA) approved Amgen's Supplemental Biologics License Application (sBLA) for Nplate® (romiplostim) to include new data in its U.S. prescribing information showing sustained platelet...

08:01
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that ORTHOtm Sera, a suite of extended antigen phenotyping, has been cleared by the U.S. Food and Drug Administration for use on the ORTHO VISION® Analyzer....


17 october 2019

08:00
CarboFix has announced today that the U.S. Food and Drug Administration (FDA) has cleared its CarboClear® Carbon Fiber Vertebral Body Replacement (VBR) System to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. The...


16 october 2019

08:00
Fidmi Medical Ltd. a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T) , announced today that it received 510K regulatory clearance from the United States Food and Drug Administration (FDA) for its low-profile enteral feeding...


15 october 2019

17:10
Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, today announced FDA's approval to initiate Denovo's Phase 2b clinical study of DB102 in patients with newly-diagnosed glioblastoma (GBM) in combination...

08:12
Subtle Medical, a healthcare technology company focused on improving the quality, efficiency, and accessibility of medical imaging, announced today 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market SubtleMRTM. SubtleMR is an...


14 october 2019

08:30
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved XARELTO® (rivaroxaban) for the prevention of venous thromboembolism (VTE), or blood clots, in hospitalized acutely...

03:11
OssDsign AB (publ) ("OssDsign" or the "Company") today announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance (K190523) to market OssDsign Cranial PSI Accessories in the US. The cleared products are a set of 3D-printed,...


11 october 2019

15:48
Eli Lilly and Company announced today that the U.S. Food and Drug Administration (FDA) has approved REYVOWtm (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of...

14:28
The U.S. Food and Drug Administration today approved Reyvow (lasmiditan) tablets for the acute (active but short-term) treatment of migraine with or without aura (a sensory phenomenon or visual disturbance) in adults. Reyvow is not indicated for the...


10 october 2019

09:00
UK-based medical devices company, Sky Medical Technology Ltd, has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its gekotm device for stimulation of the calf muscles to prevent venous thrombosis in non-surgical patients at...


9 october 2019

22:51
THINK Surgical, Inc. is pleased to announce it 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) in the United States. TSolution One®...

09:59
Beckman Coulter, a global leader in clinical diagnostics, announced today that the DxA 5000 total laboratory automation solution has received FDA 510(k) clearance and is now available for sale in the United States. Launched in Europe earlier this...


8 october 2019

13:00
The U.S. Food and Drug Administration today approved Scenesse (afamelanotide) to increase pain-free light exposure in adult patients with a history of phototoxic reactions (damage to skin) from erythropoietic protoporphyria....

08:00
Sekisui Diagnostics announces the Acucy Influenza A&B Test has received 510(k) clearance as a Class II assay from the US Food and Drug Administration (FDA), as well as, CLIA Waiver (Clinical Laboratory Improvement Amendments) for use on the Acucy...

07:15
Novartis today announced that the U.S. Food and Drug Administration (FDA) approved BEOVU® (brolucizumab-dbll) injection, also known as RTH258, for the treatment of wet age-related macular degeneration (AMD)1. BEOVU is the first FDA-approved anti-VEGF...


7 october 2019

08:35
ProTom International Holding Corporation ("ProTom"), a market-leading proton therapy technology manufacturer, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its Radiance 330 proton therapy...

08:31
Aethlon Medical, Inc. , a therapeutic medical device and technology company focused on unmet needs in global health, announced today that the FDA has approved its Investigational Device Exemption (IDE) application to initiate an Early Feasibility...


4 october 2019

14:30
Galderma, a global leader focused on meeting the world's increasing skin health needs, announced today that the U.S. Food and Drug Administration (FDA) approved AKLIEF® (trifarotene) Cream, 0.005% for the topical treatment of acne. AKLIEF Cream is...


3 october 2019

14:56
The U.S. Food and Drug Administration today approved Descovy (emtricitabine 200 mg and tenofovir alafenamide 25 mg) in at-risk adults and adolescents weighing at least 35kg for HIV-1 pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1...

11:00
America's Blood Centers (ABC) encourages the Food and Drug Administration (FDA) to continue to assess the impact of the Final Guidance issued on Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance...

07:00
Biofourmis, a fast-growing global leader in digital therapeutics, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its machine-learning and artificial intelligence (AI)-powered Biovitalstm Analytics Engine as a...


2 october 2019

08:12
Laser Associated Sciences (LAS), a medical device company based in Irvine, California, announced that its blood flow monitoring system, FlowMet-R, received its 510(k) clearance from the Food and Drug Administration (FDA). This clearance allows LAS to...

07:00
Cepheid today announced that it has received clearance from the U.S. Food and Drug Administration for Xpert BCR-ABL Ultra for monitoring disease burden in patients with Chronic Myeloid Leukemia (CML). Xpert BCR-ABL Ultra, an in vitro diagnostic test,...


1 october 2019

09:05
Luminex Corporation announced that the company has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the ARIES® MRSA Assay. The assay is an integrated, real-time, polymerase chain reaction (PCR) based, qualitative, in...

08:30
SSQ Insurance now offers coverage of pharmacogenetic tests as a new option in group insurance. These tests help analyze how a person's DNA will react to a prescription drug, making it easier for attending physicians to identify the most appropriate...

08:30
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 it has resubmitted...

07:46
Bay Labs, a growing medical technology company applying deep learning technology to emulate the expertise of highly-trained medical experts, announced today that it has achieved a number of significant milestones, including renaming the company to...


30 september 2019

13:30
Lyophilization Services of New England (LSNE), a privately held contract and development manufacturing organization, announces approval of an Abbreviated New Drug Application (ANDA) from the US Food and Drug Administration (FDA), for a sterile...

09:47
"The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that their drug INVOKANA® (Canagliflozin) has been approved by the U.S. Food and Drug Administration (FDA) to reduce the risk of end-stage kidney disease (ESKD) and...

08:30
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a new indication for INVOKANA® (canagliflozin) to reduce the risk of end-stage kidney disease (ESKD), worsening of...


27 september 2019

14:04
The U.S. Food and Drug Administration today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) in children 2 years of age and older in combination with glucocorticoids (steroid...


26 september 2019

20:00
AbbVie , a research-based global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted approval of MAVYRET® (glecaprevir/pibrentasvir) to shorten the once-daily treatment duration from 12 to 8 weeks...

15:14
The U.S. Food and Drug Administration today expanded the approval of Mavyret (glecaprevir and pibrentasvir) tablets for an eight-week duration for the treatment of adults and children ages 12 years and older or weighing at least 99 pounds who have...

14:10
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for newly diagnosed patients...

08:00
Abbott today announced the U.S. Food and Drug Administration (FDA) has approved the company's Proclaim XRtm recharge-free neurostimulation system for people living with chronic pain. The Proclaim XR platform offers a low dose of Abbott's proprietary...


25 september 2019

08:00
Abbott today announced that its ARCHITECT STAT High Sensitivity Troponin-I blood test has received clearance from the U.S. Food and Drug Administration (FDA). As one of the most researched troponin diagnostic tests, doctors in the U.S. can now...


24 september 2019

15:19
The U.S. Food and Drug Administration announced today the approval of Jynneos Smallpox and Monkeypox Vaccine, Live, Non-Replicating, for the prevention of smallpox and monkeypox disease in adults 18 years of age and older determined to be at high...

10:23
Solio (https://www.soliotherapy.com/) announced the launch of its signature pain-relief device, Alfa Plus, into the American marketplace after recently securing FDA clearance. Solio Alfa Plus is the first pain management device ever cleared by the...

10:15
Aurora Concussion Therapy Systems, Inc. (Aurora - CTS), a Minnesota-based privately held company developing a non-invasive medical device to treat concussions and other brain trauma, today announced that the United States Food and Drug Administration...

10:00
Tarsius Pharma today announced the acceptance of its Investigational New Drug (IND) application for TRS01 by the U.S. Food and Drug Administration (FDA). The company is developing TRS, a breakthrough, bio-inspired platform technology for the...

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