Le Lézard

News by subject: FDA

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25 october 2021

07:00
Alkermes plc  today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to nemvaleukin alfa (nemvaleukin), the company's novel, investigational, engineered interleukin-2 (IL-2) variant immunotherapy, in...

06:45
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), and Clearside Biomedical, Inc. ("Clearside"), a biopharmaceutical company revolutionizing the...


21 october 2021

16:06
Naviswiss, a Swiss-based medical technology company receives clearance from the FDA to market Naviplan in the United States. Naviplan is a digital pre-operative planning application enabling orthopedic surgeons to perform navigated CT-based total hip...

14:42
Padagis today announced the FDA approval and launch of an AB-rated generic version of Doxil® (Doxorubicin Liposome Injection) through its partnership with Ayana Pharma Ltd. Doxil® Liposome Injection is an anthracycline topoisomerase inhibitor...

10:33
Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, announced that the clinical trial of PD-L1/TGF-? dual-targeting antibody (GT90008)...

08:30
Castle Creek Biosciences, Inc., a clinical-stage cell and gene therapy company focused on developing and commercializing disease-modifying therapies for patients suffering from rare diseases for which there is a lack of available treatment options,...


20 october 2021

17:29
Dupixent is the only biologic medicine to improve lung function in children aged 6 to 11 years in a randomized Phase 3 trial, supporting potential as a best-in-class option Only biologic medicine approved for children with oral...

09:00
Cognetivity Neurosciences Ltd. (the "Company" or "Cognetivity") today announced that it has received notification from the US Food and Drug Administration (FDA) that its 510(k) submission for the CognICA Integrated Cognitive Assessment (ICA) has...


19 october 2021

09:05
 ? A potential cure for HIV, developed by pioneering research scientist Dr. Serhat Gumrukçu, Director of the Seraph Research Institute (SRI), and his team have successfully completed the Pre-Investigational New Drug (IND) process for the U.S. Food...


18 october 2021

10:41
The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases. Cyltezo (adalimumab-adbm), originally approved in August 2017, is both biosimilar to, and interchangeable with (may be...

08:00
Thermo Fisher Scientific, the world leader in serving science, today announced that it received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to run COVID-19 tests from saliva samples collected with the Spectrum...

07:00
Alkermes plc  today announced that LYBALVI® (olanzapine and samidorphan) is now available by prescription in the United States (U.S.) for the treatment of adults with schizophrenia, and for the treatment of adults with bipolar I disorder, as a...

06:00
Oyster Point Pharma, Inc. , today announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYAtm (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the...


15 october 2021

19:21
Boehringer Ingelheim today announced the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) for Cyltezo® (adalimumab-adbm) as the first Interchangeable biosimilar with Humira® (adalimumab). The FDA...

16:11
Johnson & Johnson (the Company) today announced the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted 19-0 to recommend Emergency Use Authorization (EUA) for a booster...

10:56
Seqirus, a global leader in influenza prevention, and a business of CSL Limited , today announced that the U.S. Food and Drug Administration (FDA) has approved FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the company's cell-based quadrivalent...


14 october 2021

07:21
Regeneron Pharmaceuticals, Inc.  today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for REGEN-COV® (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized...


13 october 2021

06:45
The U.S. Food and Drug Administration (FDA) has approved Eli Lilly and Company's Verzenio® (abemaciclib), in combination with endocrine therapy (tamoxifen or an aromatase inhibitor), for the adjuvant treatment of adult patients with hormone...


12 october 2021

16:38
CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the full approval of its Investigational...

15:44
Averix Bio is proud to announce that it has successfully completed an independent audit for 21 CFR Part 210 and Part 211 cGMP compliance of API phytocannabinoid CBD isolate in the U.S. as well as for ICH Q7 standards....

09:06
Cochlear Limited , the global leader in implantable hearing solutions, obtained U.S. Food and Drug Administration (FDA) approval and clearance in the last month for its Cochleartm Remote Assist solution in the Nucleus® and Baha® Systems. The FDA...

09:02
Today, Withings, pioneers of the connected health revolution, is pleased to announce ScanWatch, its globally acclaimed and most medically advanced wearable, has received FDA clearance....

08:52
7 Daze LLC, a leading premium e-liquid manufacturer, revealed today that it has filed an appeal in the U.S. Court of Appeals for the Ninth Circuit against the U.S. Food and Drug Administration (FDA) in response to FDA's issuance of a marketing denial...


8 october 2021

18:20
Today, the U.S. Food and Drug Administration approved Rethymic for the treatment of pediatric patients with congenital athymia, a rare immune disorder. Rethymic is the first thymus tissue product approved in the U.S. "Today's action marks the first...

15:02
Brii Biosciences Limited ("Brii Bio" or the "Company", stock code: 2137.HK) a multi-national company developing innovative therapies for diseases with significant unmet medical needs and large public health burdens, today announced the filing of an...

08:19
Alpha Tau Medical, the developer of the innovative alpha-radiation cancer therapy Alpha DaRTtm, is pleased to announce that it has received Breakthrough Device Designation for Alpha DaRT from the U.S. Food and Drug Administration (FDA) for the...

08:04
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to...


7 october 2021

09:42
Today, U.S. Senators Cory Booker, D-N.J., Rand Paul, R-Ky., Ben Ray Lujan, D-N.M., Mike Braun, R-Ind., and John Kennedy, R-La., introduced the FDA Modernization Act of 2021 to modernize drug development and to authorize the FDA to accept...

08:01
Venclose Inc., a privately-held Silicon Valley medical device company focused on innovative treatment procedures for venous reflux disease today announced FDA 510(k) clearance for Venclose Maventm, a novel radiofrequency ablation (RFA) catheter for...

07:55
Recursion , a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, machine learning and engineering, today announced that the U.S. Food and Drug Administration (FDA) has...


6 october 2021

07:00
RedHill Biopharma Ltd. ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced that Medi-Cal - California's Medicaid Health Care program covering two million patients - has added Talicia® (omeprazole magnesium,...


5 october 2021

10:00
Colospan  which develops novel solutions for colorectal surgery, announced today the appointment of Gregory D. Casciaro to its board of directors. "We are excited to welcome Greg to the Board of Directors. With four decades of medical device...

09:30
iotaMotion Inc., a leader in developing advanced surgical systems for cochlear implant surgery, announced FDA granted its' De Novo classification request to market the iotaSOFTtm insertion system. iotaSOFT is the world's first and only...

03:00
Amber Implants, an innovative medical technology company developing next generation spinal implants for spinal injuries, today announces its VCFix® spinal system, which aims to improve the treatment of vertebral fractures, has been granted the...


4 october 2021

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 submission of a...


30 september 2021

12:58
Today, the U.S. Food and Drug Administration cleared the first new major technological improvement for Computed Tomography (CT) imaging in nearly a decade. "Computed tomography is an important medical imaging tool that can aid in diagnosing disease,...

08:38
Immix Biopharma, Inc. ("ImmixBio"), a biotechnology company pioneering Tissue Specific Therapeutics (TSTx)TM for oncology and inflammation, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to...


29 september 2021

13:44
ViewRay, Inc. today announced that the company has received acceptance from the FDA on their recent submission for new MRIdian features focused on enhancing on-table adaptive workflow efficiency and expanding clinical utility. ViewRay will be...

11:22
Breckenridge Pharmaceutical, Inc. announces today that the U.S. Food and Drug Administration has granted approval of its Abbreviated New Drug Application for Teriflunomide Tablets (generic for Aubagio®). This product was developed in collaboration...

09:00
BIOTRONIK announced today it received U.S. Food and Drug Administration (FDA) approval of its Orsiro® Mission bioabsorbable polymer drug-eluting stent system (BP-DES). The company also announced the first U.S. implant and full commercial launch of...

07:00
Pharmazz, Inc., a biopharmaceutical company focused on developing and commercializing novel therapeutics to treat patients in critical care, is pleased to announce that its Phase III clinical study of the drug candidate, centhaquine, has been...

07:00
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 that the U.S. Food and Drug Administration (FDA) has...


28 september 2021

18:42
AbbVie today announced that the U.S. Food and Drug Administration (FDA) approved QULIPTAtm (atogepant) for the preventive treatment of episodic migraine in adults.1 QULIPTA is the first and only oral calcitonin gene-related peptide (CGRP) receptor...

17:45
Eli Lilly and Company today announced that the U.S. Food and Drug Administration (FDA) has granted approval of a new indication for ERBITUX® (cetuximab injection) in combination with BRAFTOVI® (encorafenib), marketed by Pfizer, Inc., for the...

09:00
Nonagen Bioscience Corp, pioneers in the development of liquid biopsy tests for the detection of human cancers, today announced Oncuriatm, their non-invasive bladder cancer test capable of predicting response to therapy, has been granted U.S. Food...

08:34
Selux Diagnostics, Inc., which is leading a new era in personalized diagnostics to combat superbug infections and fight antibiotic resistance, today announced that its Next Generation 'Phenotyping' (NGP) platform has received Breakthrough Device...

07:00
European Union regulatory submission planned by end of 2021 Regeneron Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has accepted for priority review the supplemental Biologics License Application (sBLA) for...


27 september 2021

23:01
BioArctic AB's (publ) partner Eisai today announced that they have initiated a rolling submission to the U.S. Food and Drug Administration (FDA) of a Biologics License Application (BLA) for lecanemab (BAN2401), an investigational anti-amyloid beta...

09:00
Immunoforge (Co-CEOs Sung-min Ahn, Kiho Chang), a company specializing in developing new drugs for rare musculoskeletal diseases, has reported that their new drug candidate PF1801 has received Orphan Drug Designation (ODD) from the U.S. FDA for the...


24 september 2021

20:09
Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Repatha® (evolocumab) as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10...

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