Le Lézard

News by subject: IMA

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28 march 2024

06:00
Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands (RVG 130527). This landmark approval marks a significant milestone in our ongoing commitment to...


26 march 2024

11:54
Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment...


25 march 2024

06:58
Innodem Neurosciences, a leading digital health and AI company, announced today that its ETNAtm-MS has been cleared for commercial use by Health Canada.  The Eye Tracking Neurological Assessment for Multiple Sclerosis (ETNAtm-MS) is a software as a...


19 march 2024

21:03
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Singapore Health...

07:00
CSL Vifor today announced that Health Canada has authorized Ferinject (ferric carboxymaltose) for the intravenous (IV) treatment of iron deficiency anemia in adult and pediatric patients one year of age and older when oral iron preparations are not...


18 march 2024

07:00
Inspiratm Technologies OXY B.H.N. Ltd. (the "Company" or "Inspira"), a breakthrough medical technology company, is excited to announce the AMAR submission for approval of the INSPIRAtm ART100, marking a significant milestone in Inspira's venture...


13 march 2024

04:30
Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, is pleased to announce the approval in Brazil of STIMULAN as a calcium...

04:30
Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection management in bone and soft tissue, is pleased to announce the approval in Brazil of STIMULAN as a calcium...


5 march 2024

12:32
X-Nav Technologies, LLC announced that the X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR....

07:17
Rippon Ubhi, Country Lead, Sanofi UK and Ireland, said: "We are extremely disappointed and saddened by the decision by the National Institute for Health and Care Excellence (NICE) not to recommend Xenpozyme (olipudase alfa) as a treatment for acid...

00:32
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major...


4 march 2024

07:00
YolTech Therapeutics, a biotech company developing in vivo gene editing therapies to treat rare genetic diseases, today announced the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has officially  approved the...

03:00
Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial MR-guided focused ultrasound (MRgFUS) has been granted NUB status 1 for the treatment of essential tremor (ET) in Germany. This significant...


1 march 2024

08:50
CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that today the National Medical Products Administration...

01:55
Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced it received IND (Investigational New Drug) approval of its self-developed drug JAB-30300 (P53 Y220C activator) from the FDA of the U.S....


29 february 2024

04:00
Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson...


27 february 2024

07:01
As previously announced, planning is underway with FDA to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection (CDI)As anticipated, an End of Phase 2 Meeting (EOP2) with FDA is now confirmed to occur...


26 february 2024

18:10
Everest Medicines (HKEX 1952.HK) and Kezar Life Sciences, Inc. announced today that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) approved Kezar's investigational new drug (IND) application for...


21 february 2024

19:48
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company")'s partner Pfizer Inc. announced that the European Commission (EC) has granted marketing authorization for VELSIPITY® (etrasimod) in the European Union to treat patients 16 years of age...

03:16
Zylox-Tonbridge (2190.HK), a medical device company specializing in peripheral and neurovascular interventions, proudly announces the recent marketing approvals granted by the Ministry of Health and Prevention in the United Arab Emirates for five of...


12 february 2024

07:05
Merck , known as MSD outside the United States and Canada, announced that Health Canada has granted approval of  KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 therapy, in combination with trastuzumab, fluoropyrimidine- and platinum-containing...


8 february 2024

09:36
CSOFT Health Sciences, leaders in clinical trial translation, are pleased to announce the launch of their co-authored white paper for medical device manufacturers seeking re-certification under the updated EU Medical Device Regulation (EU MDR), in...


5 february 2024

08:00
Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain management, is pleased to announce the approval of the Investigational New Drug...


31 january 2024

19:00
In the news release issued 19-Sep-2023 by Deep Bio over PR Newswire, we are advised by the company that in the initial release, it was inaccurately stated in the headline, first and second paragraphs that Deep Bio obtained marketing authorization...


29 january 2024

12:17
Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) to have MR-guided focused ultrasound (MRgFUS) reimbursed for people...

09:00
Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug...

04:00
Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a rare and debilitating disease. This first-in-class PRS inhibitor has recently received 'Orphan Drug...

03:17
Asieris Pharmaceuticals (Stock Code: 688176.SH), a global biopharmaceutical company specializing in discovering, developing, and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced the...


25 january 2024

16:05
PTC Therapeutics, Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion following the re-examination procedure for the conditional marketing authorization...


24 january 2024

14:35
Otsuka Pharmaceutical Canada Inc. (Otsuka) and Lundbeck Canada Inc. (Lundbeck) announce that Health Canada has issued a Notice of Compliance for REXULTI® (brexpiprazole) for use in the symptomatic management of agitation associated with Alzheimer's...


23 january 2024

07:55
Anixa Biosciences, Inc. ("Anixa" or the "Company") , a clinical-stage biotechnology company focused on the treatment and prevention of cancer, today announced that its collaborator, Cleveland Clinic, has received a "Decision to Grant" notice from the...


22 january 2024

22:53
GC Biopharma Corp. (006280.KS) announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to its intracerebroventricular (ICV) Enzyme Replacement Therapy (ERT) candidate, GC1130A, designed for Sanfilippo Syndrome...

09:00
NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd, announced today that the European Commission (EC) has granted orphan drug designation to NS-229, which is being developed for the treatment of the rare disease eosinophilic...

08:41
Single Pass, a leading provider of innovative medical devices, is pleased to announce an exclusive distribution agreement with Mermaid Medical Group, a renowned global medical technology company. This partnership will bring Single Pass's cutting-edge...


18 january 2024

08:30
Halozyme Therapeutics, Inc. ("Halozyme") today announced that argenx received approval from Japan's Ministry of Health, Labour and Welfare (MHLW) for VYVDURA® (efgartigimod alfa and hyaluronidase-qvfc) injection co-formulated with Halozyme's...


11 january 2024

03:00
AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE certification for its AI-powered MRI enhancement solution 'SwiftMRtm'. This certification allows AIRS...


10 january 2024

04:00
Pulsenmore , the global leader in self-scan ultrasound technology for home use, proudly announces the approval of its pioneering prenatal care solution by the Brazilian Health Regulatory Agency (ANVISA), marking a significant milestone in the...

01:52
Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for autoimmune diseases and pain, has announced today that China National Medical Products Administration (NMPA)...


9 january 2024

02:00
AbbVie today...


8 january 2024

06:45
Medtronic plc , a global leader in healthcare technology, today announced CE (Conformité Européenne) Mark approval for the MiniMedtm 780G system with Simplera Synctm, a disposable, all-in-one continuous glucose monitor (CGM) requiring no fingersticks...


4 january 2024

08:40
JW Therapeutics (HKEx: 2126), an independent and innovative biotechnology company focusing on developing, manufacturing and commercializing cell immunotherapy products, announced that the National Medical Products Administration (NMPA) of China...


3 january 2024

08:33
Rehabtronics Inc announces it has successfully upgraded its ISO13485:2016 quality certification to include the internationally-recognized Medical Device Single Audit Program (MDSAP) standard. The additional certification confirms the company's...


26 december 2023

23:51
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that its New Drug Application (NDA) for...

07:00
Senhwa Biosciences, Inc. (TPEx: 6492), a drug development company focusing on first-in-class therapeutics for oncology, rare diseases, and infectious diseases, announced today that Taiwan Food and Drug Administration has approved its Phase II IND...

04:26
Jemincare, a leading pharmaceutical company from China, announced that its wholly owned subsidiary company, Shanghai Jemincare Pharmaceutical Co., Ltd., recently received 6 approvals of clinical trials for its innovative drugs in the field of cancer,...


21 december 2023

09:30
Northwest Biotherapeutics ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and...

09:00
NS Pharma, Inc. (NS Pharma), a subsidiary of Nippon Shinyaku Co., Ltd., announced that, on December 13, 2023, the European Commission (EC) has granted orphan drug designation for NS-089/NCNP-02, which is being developed for the treatment of Duchenne...


13 december 2023

20:47
Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer,...

09:00
Inovedis GmbH, a medical technology start-up dedicated to offering innovative solutions that contribute both to optimized patient care as well as minimizing the complexity of surgical interventions, today announced that the first two patients were...


12 december 2023

08:05
Blueprint Medicines Corporation? today announced the European Commission has approved AYVAKYT® (avapritinib) for...

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