Le Lézard

News by subject: IMA

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19 june 2023

08:55
Sirnaomics Ltd. (the "Company"; stock code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, today announced the advancement of STP705 for the...


15 june 2023

07:30
Thorne HealthTech, Inc. ("Thorne") , a leader in delivering innovative solutions for a personalized approach to health and wellness, announced today that its NanoDrop device has received a CE (Conformite Europeenne) Mark certification and has...


13 june 2023

21:00
Gencurix, a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations...


9 june 2023

00:12
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities...


8 june 2023

22:30
On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities...


7 june 2023

23:02
BioArctic AB's (publ) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBItm), an investigational anti-amyloid beta (A?) protofibril[1] antibody, for the...


5 june 2023

08:00
IFF today announced its HOWARU® probiotic strain Lacticaseibacillus rhamnosus HN001® has won the NIS Golden Açaí Awards' Applied Ingredients category. The award, presented at a ceremony in São Paulo, is given in recognition of IFF's HOWARU® HN001®...


2 june 2023

08:00
Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and...

03:51
TWi Biotechnology (TWiB), a clinical stage biopharmaceutical company specializing in development of repositioned drugs for unmet medical needs, is currently seeking participants for a Phase 1 clinical trial of a topical gel called tofacitinib for the...

03:00
Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and...


1 june 2023

23:43
Akeso Inc. (9926. HK, "Akeso") announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1)...


31 may 2023

14:11
Emmaus Life Sciences, Inc. , a leader in sickle cell disease treatment, announced today that it has received a Medicine Registration Certificate (DRN-10164/23) from the Bahrain National Health Regulatory Authority (NHRA) granting marketing...


30 may 2023

07:00
Cepheid announced today that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients...

07:00
SK bioscience, a global innovative vaccine and biotech company committed to...


29 may 2023

21:00
...


23 may 2023

16:13
INOVIO , a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Commission (EC) has granted orphan...


22 may 2023

08:49
Following the exclusive licensing agreement with Urovant Sciences GmbH, Pierre Fabre announced today the start of the EU marketing authorization application procedure (centralized procedure) for Vibegron, a novel, potent, and selective human ?3...


16 may 2023

07:30
Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Patent Office has...


11 may 2023

06:00
"Today we are pleased to announce that Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe...

03:00
Nippon Express Italia S.p.A. (hereinafter "NX Italia"), a group company of NIPPON EXPRESS HOLDINGS, INC., has acquired IATA CEIV Pharma certification*, a quality certificate for pharmaceutical transport established by the International Air Transport...

02:00
Nippon Express Italia S.p.A. (hereinafter "NX Italia"), a group company of NIPPON EXPRESS HOLDINGS, INC., has acquired IATA CEIV Pharma certification*, a quality certificate for pharmaceutical transport established by the International Air Transport...


9 may 2023

20:00
Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major...


8 may 2023

04:50
Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the China...


5 may 2023

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, announced that AB011 in combination with atezolizumab monoclonal...

06:46
Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the...


4 may 2023

09:01
sanofi-aventis Canada Inc. (Sanofi Canada) is pleased to announce that Health Canada has issued a Notice of Compliance for DUPIXENT® (dupilumab injection) for the treatment of patients aged 12 years and older, weighing at least 40 kg, with...


3 may 2023

06:58
Bausch Health Companies Inc. is pleased to announce the availability across Canada of its new prescription treatment RYALTRIS® (olopatadine hydrochloride and mometasone furoate nasal spray). RYALTRIS has been approved by Health Canada for the...


27 april 2023

09:00
PHYTO-GENIOUS, a leading innovator in healthy aging solutions, has announced the launch of its revolutionary line of high-purity Nicotinamide Mononucleotide (NMN) products. By obtaining Natural Product Number (NPN) Licenses from Health Canada and...


26 april 2023

09:00
On the heel of the regulatory meeting with Health Canada on March 31st 2023, CELL Technologies Inc. announces the submission of the clinical data of its stem cell program in pain for Health Canada approval. CELL is aiming to become the first...

08:00
INOVIO , a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Committee for Orphan Medicinal...


23 april 2023

22:00
Pie Medical Imaging, a global leader in cardiac imaging, announced it has received NINSHO Medical Device Certification for CAAS Qardia, their innovative echocardiography software platform....


20 april 2023

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, announced that CT041, an autologous CAR T-cell product candidate against...


18 april 2023

09:17
Syantra announced today that it has obtained CE marking for the Syantra DXTM Breast Cancer test. Syantra DXTM Breast Cancer is a minimally invasive blood test for the detection of an active breast cancer signature - in the earliest stages when it is...

07:30
HuidaGene Therapeutics (????; HuidaGene), a clinical-stage biotechnology company developing CRISPR-based programmable genomic medicine, announces that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has...


17 april 2023

02:00
?  Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn's disease ?  Third gastroenterology indication...


4 april 2023

08:53
BioPhotas, Inc., the manufacturer of the award-winning Celluma SERIES of light therapy devices, announced today that the Company received certification to European Council Medical Device Regulation 2017/745 for low level light therapy devices. Over...


3 april 2023

07:00
Alexion, AstraZeneca Rare Disease, today announced that Health Canada has granted a Notice of Compliance (NOC) for KOSELUGO (selumetinib) for the treatment of pediatric patients aged two years and above, with neurofibromatosis type 1 (NF1) who have...

01:44
Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that the Denosumab solution for injection (trade name: MAILISHU, project code: 9MW0311), which is developed by its wholly-owned subsidiary...


29 march 2023

20:00
ImmVira announced that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ("NMPA") for Phase I clinical trial in China on March 29, 2023. Previously, MVR-C5252 also...

08:51
In cooperation with Oak Crest Institute of Science based in California, the H3D Foundation is pleased to announce the award of $721,209 USD in funding from the United States Agency for International Development (USAID) through MATRIX, a USAID project...


28 march 2023

08:00
This approval allows the use of the IceSense3 disposable cryoprobes in combination with the Company's IceSense3 console, which was previously approved by the NMPAProducts to be distributed in China through agreement with Shanghai Medtronic Zhikang...

07:05
WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner Amicus Therapeutics ("Amicus") on receiving European Commission's approval for...

07:00
Prelude Corporation (PreludeDxtm), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT)...

03:36
OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP"). According to the terms of the...


23 march 2023

11:28
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide),...


22 march 2023

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, announced its 2022 Annual Results. Business Highlights Zevor-cel (CT053)...


21 march 2023

08:45
Neogen Corporation announced today that the U.S. Environmental Protection Agency (EPA) has approved additional virucide claims to its Neogen® Viroxide Supertm disinfectant. These label claims specify that Neogen Viroxide Super kills viruses* on hard...


20 march 2023

09:00
Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest...


17 march 2023

09:00
According the latest data released at the Clinical Trials Implied Approval section on the website of China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences (hereinafter referred to as...

03:13
According the latest data released at the Clinical Trials Implied Approval section on the website of China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences (hereinafter referred to as...

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