Le Lézard

News by subject: FDA

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21 september 2020

19:16
Humble Juice Co., a leading e-liquid manufacturer with a humble beginning, announced today the receipt of its Premarket Tobacco Product Application (PMTA) acceptance letter from the U.S. Food and Drug Administration. Humble submitted its application...

11:45
What: National protest on October 7, 2020 Where: Outside state capitols/DEA/Medical Board/select locations To locate rally: Rallies Chart To join FB page: https://DontPunishPainRally.com/Facebook While attempting to rein in the abuse and misuse of...

09:15
ENGLEWOOD, Colo., Sept. 21, 2020 /PRNewswire/ ? Ampio Pharmaceuticals, Inc. (the "Company") announces the receipt of an Investigational New Drug ("IND") from the U.S. Food and Drug Administration ("FDA"), allowing the Company to proceed with...

08:16
Liminal BioSciences Inc. ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, announced today that the U.S. Food and Drug Administration ("FDA") acknowledged receipt of the resubmission, by its US subsidiary,...


19 september 2020

07:14
Yiling Pharmaceutical Co., Ltd. announced on Friday that it had received the approvals of the Abbreviated New Drug Applications (ANDA) about Lisinopril Tablets and Acyclovir Capsules, from United States Food and Drug Administration (hereinafter...


18 september 2020

09:15
ACE Medical Co. has been granted 510(k) clearance from the FDA in order to sell and market their surgical equipment for the use in the spine. According to the FDA, "a 510(k) is a premarket submission made to FDA to demonstrate that the device to be...


17 september 2020

16:05
MorphoSys AG and I-Mab  today jointly announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug application (IND) for MorphoSys' investigational human anti-C5aR1 antibody MOR210/TJ210 for the treatment of...


16 september 2020

09:40
AVM Biotechnology has received FDA permission to proceed with clinical trials to evaluate its proprietary drug AVM0703 in the treatment of Acute Respiratory Distress Syndrome (ARDS) mediated by COVID-19 or Influenza patients. This is AVM's second...

09:00
Accelerate Diagnostics, Inc. today announced that the Company has received U.S. Food and Drug Administration (FDA) clearance for a new suite of product enhancements to the Accelerate Pheno® system, which improve performance and expand the system's...


15 september 2020

08:15
Highlights: Integration of Dual Energy CT (DECT) images in the Eclipse planning process reduces range uncertainty and helps clinicians' spare healthy tissue. Graphics Processing Unit (GPU) accelerates the speed of Monte Carlo proton dose calculation...

08:00
Ardelyx, Inc. , a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New...


14 september 2020

09:00
B-Temia Inc. (the "Company") announces that it received 510(k) clearance from the US regulator for the commercialization of its powered human mobility device KeeogoTM Dermoskeleton System in the United States of America. This clearance opens the...

08:44
Neurocrine Biosciences, Inc. today announced that 50 mg capsules of ONGENTYS® (opicapone), the first and only FDA-approved once-daily catechol-O-methyltransferase (COMT) inhibitor, are now available by prescription in the United States. ONGENTYS was...

07:57
Canada-based biotechnology front-runner LuminUltra announced today that it has submitted its GeneCount® COVID-19 RT-qPCR Assay Kit (COVID-19 Assay) to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and to Health...


11 september 2020

14:15
Gan & Lee Pharmaceuticals Co., Ltd. (hereinafter referred to as Gan & Lee, stock code: 603087.SH), a global biopharmaceutical company, today announced that the U.S Food and Drug Administration (FDA) has granted Orphan Drug Designation for GLR2007,...

10:34
Streck Cell-Free DNA BCT received U.S. Food and Drug Administration De Novo clearance for In Vitro Diagnostic use when paired with the Guardant360 CDx liquid biopsy assay. Cell-Free DNA BCT is the first and only circulating nucleic acid first blood...


10 september 2020

08:02
Halozyme Therapeutics, Inc. today announced that its collaborator Janssen Biotech, Inc. (Janssen) has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval of DARZALEX FASPROtm...


9 september 2020

10:00
ExsoMed Corporation, a privately held U.S.-based medical device company providing orthopaedic surgeons with innovative solutions in hand surgery, received 510(k) clearance from the United States Food and Drug Administration for its Four Corner Fusion...

09:16
After successful clinical trials, Ideal Image, America's #1 MedSpa, proudly announces all 150+ locations will offer the FDA-approved service CoolTonetm by Coolsculpting® which leverages Magnetic Muscle Stimulation (MMS technology) to strengthen the...

07:00
Peptilogics, a biotechnology platform company leveraging computational design to discover novel peptide therapeutics, today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for PLG0206, the company's...


8 september 2020

09:00
Athena Bioscience, LLC, a specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved QDOLOtm (tramadol hydrochloride) Oral Solution 5mg/1mL C-IV, an opioid agonist indicated in adults for the...

07:55
The U.S. Food and Drug Administration (FDA) has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify RET fusion-positive, metastatic non-small cell lung cancer (NSCLC) patients...

06:00
Liminal BioSciences Inc. ("Liminal BioSciences" or the "Company"), a clinical-stage biopharmaceutical company, today announced that the...


4 september 2020

19:00
Blueprint Medicines Corporation , a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, today announced that the U.S. Food and Drug Administration (FDA) has approved GAVRETOtm (pralsetinib) for...

15:29
Project ALS, a non-profit 501(c)3 organization that funds research toward the first meaningful treatments for amyotrophic lateral sclerosis (ALS), announced today that the Food and Drug Administration (FDA) has granted orphan drug designation to...

10:58
Reynolds American Inc. ("Reynolds") announces today its final submission of a group of Premarket Tobacco Product Applications ("PMTAs") to the U.S. Food and Drug Administration ("FDA") through R.J. Reynolds Vapor Company ("RJRV"), seeking orders...


3 september 2020

17:12
The U.S. Food and Drug Administration (FDA) today approved two additional doses of Eli Lilly and Company's  Trulicity® (dulaglutide). The approval expands the label of once-weekly Trulicity to include 3.0 mg and 4.5 mg doses based on data from...

15:01
DetectaChem, the global leader in innovative portable threat detection technologies used daily by U.S. Homeland Security, Department of Defense and first responder agencies around the world, today announces their MobileDetect Bio (MD-Bio) BCC19...

11:46
Alphamab Oncology (stock code: 9966 HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to KN046, a recombinant humanized PD-L1/CTLA-4 bispecific antibody developed by Jiangsu Alphamab...

05:01
Seqster, the award-winning SaaS-based healthcare technology company enabling patient-centric interoperability, today announced that it reached a significant milestone with the receipt of its FDA 21 CFR PART 11 Compliance letter. This regulatory...


2 september 2020

16:15
Slayback Pharma, LLC announced today that it has received final approval for Icatibant Injection 30 mg/3 ml (10 mg/ml) in a Prefilled Syringe - a generic equivalent of Firazyr....


1 september 2020

09:37
Medtronic plc , the global leader in medical technology, today announced it has received U.S. Food and Drug Administration (FDA) approval of its MiniMedtm 770G hybrid closed loop system. This newest insulin pump system offers the company's most...


31 august 2020

09:45
Sound Pharmaceuticals, Inc. (SPI) is pleased to announce that the FDA has allowed two Phase 2 studies to begin testing ebselen (SPI-1005) in COVID-19 patients. SPI is developing SPI-1005, a novel anti-inflammatory drug which was recently shown to...

08:45
Innocoll Holdings Limited, a specialty pharmaceutical company and portfolio business of Gurnet Point Capital, announced today that the US Food and Drug Administration (FDA) has approved Xaracoll®  for acute postsurgical pain relief for up to 24 hours...


29 august 2020

06:34
Oncopeptides AB (publ)  today announces that the US Food and Drug Administration, FDA, has granted priority review for Oncopeptides' New Drug Application seeking approval of melflufen (INN melphalan flufenamide), in combination with dexamethasone for...


27 august 2020

08:12
B. Braun Medical Inc. (B. Braun), a leader in infusion therapy and pain management, announced today that it has received 510(k) clearance from the US Food and Drug Administration for the SpaceStation MRI to allow Space® infusion pumps to continuously...

07:00
Laurent Pharmaceuticals Inc., a Montreal-based biopharmaceutical company, today announced that it has received approval from the Food and Drug Administration (FDA) to start enrolling U.S. patients in RESOLUTION, a multicentric Phase 2 randomized...

01:15
Cassiopea SpA (SIX: SKIN) today announced that the United States Food and Drug Administration (FDA) approved Winlevi® (clascoterone cream 1%) for the treatment of acne in patients 12 years and older. Notwithstanding acne being the most prevalent skin...


26 august 2020

10:30
Alcami, a US-based contract development and manufacturing organization (CDMO), announced today that it is providing commercial manufacturing services for Trevena's newly approved OLINVYK. OLINVYK (oliceridine) injection is an opioid approved in...

08:42
Jointechlabs ? a leader in point-of-care regenerative medicine therapies ? today announced that the U.S. Food and Drug Administration (FDA) cleared the company's MiniTCtm for point-of-care fat tissue processing designed to obtain microfat (or fat...

07:00
Chemomab Ltd., a clinical-stage biotech company focusing on discovery and development of innovative therapeutics for fibrosis-related diseases, today announces that the European Commission (EC) has granted Orphan Drug Designation (ODD) to its lead...


25 august 2020

11:55
Royal Philips , a global leader in health technology, and B. Braun Medical Inc., a global market leader1 in regional anesthesia and pain management, today announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Onvision®, a...

11:21
Recordati Rare Diseases Inc., today announced the U.S. Food and Drug Administration (FDA) has approved CYSTADROPS® (cysteamine ophthalmic solution) 0.37%. CYSTADROPS is a new, viscous eye drop solution that depletes corneal cystine crystal deposits...

09:00
EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to the new drug application (NDA) for...

08:45
AbbVie today announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for RINVOQtm (upadacitinib; 15 mg, once daily), a selective and reversible JAK inhibitor, for the treatment of adult...

08:39
CNS Pharmaceuticals, Inc. ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the brain and central nervous system, today provided an update on the Company's...

07:00
REGENXBIO Inc. , a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy based on its proprietary NAV® Technology Platform, today announced the clearance of the Investigational New Drug...

04:00
Two innovative bio-pharma companies specialized in plasma-derived therapeutics - Kedrion Biopharma of Italy and Kamada Ltd. of Israel - are continuing their work on the development, manufacturing and clinical distribution of a plasma-derived...


24 august 2020

12:21
On August 20, 2020, VAPORESSO received the acceptance letter for the first round of its PMTA applications from the FDA - only three days after submission. According to its U.S. scientific CRO agent, the application received positive comments from FDA...

09:00
Stryker announced today the launch of the Surpass Evolve Flow Diverter following approval by the U.S. Food and Drug Administration. It is the first 64-wire cobalt chromium flow diverter in the U.S. designed to re-direct blood flow and promote...

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