Le Lézard

News by subject: IMA

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11 april 2022

19:42
Telix Pharmaceuticals Limited  today announces its ProstACT TARGET Phase II clinical trial of the Company's prostate cancer antibody therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients experiencing a first recurrence of prostate-specific...

10:03
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of HANSIZHUANG (serplulimab), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with chemotherapy for the...

07:45
Merck, , known as MSD outside Canada and the United States, announced today that Health Canada has approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age for the prevention of infection caused by the Human...

04:05
The board of directors of Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group",Stock code:2179.HK) is pleased to announce that, on April 9, 2022, the Company has received the European Union (EU) Qualified...


7 april 2022

00:59
Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is...


6 april 2022

23:20
Bened Biomedical announced recent approval of the company's probiotic L. plantarum PS128 in Thailand and Canada. Authorities in each country also endorsed health claims that may be made about the strain. Local distributors will launch PS128 products...

08:35
CNS Pharmaceuticals, Inc. ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has received approval...

07:00
Seegene Inc. (KQ 096530), South Korea's leading molecular diagnostics (MDx) company, today announced that its Allplextm RV Master Assay has received approval from Australia's Therapeutic Goods...

00:40
Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases announced...


5 april 2022

08:49
PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is proud to announce that their PDO device continues to comply with The Medical Device Single Audit Program ?...


4 april 2022

07:00
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving RYBREVANT® (amivantamab), a fully-human, bispecific antibody, for the treatment of adult...


1 april 2022

01:44
Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 2021 annual results. Highlights: Anniko®...


31 march 2022

06:00
Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced submission of its request to expand the conditional marketing authorization (CMA) of...

00:20
JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the...


29 march 2022

15:17
Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently...


28 march 2022

09:00
Seqirus, a global leader in influenza prevention, announced today that it has received Health Canada approval of FLUCELVAX® QUAD (Influenza Vaccine), its cell-based quadrivalent influenza vaccine for an expanded age indication for children as young...


25 march 2022

15:20
Today sanofi-aventis Canada Inc. (Sanofi) announced the approval of Libtayo® (cemiplimab) for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic...

10:15
Blueprint Medicines...

09:02
Shanghai Henlius Biotech, Inc. (2696.HK) announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of...

08:00
Vertex Pharmaceuticals (Canada) Incorporated today announced that Health Canada has granted Marketing Authorization for the expanded use of PrKALYDECO® (ivacaftor) in patients from 4 months to 18 years of age and weighing at least 5 kg with the...


24 march 2022

09:00
Abbott today announced that the Japanese Ministry of Health,...


23 march 2022

07:00
Innova Medical Group, Inc., a global health screening and diagnostic innovator and a world leader in the manufacture and distribution of...


22 march 2022

16:02
First authorization of Novavax' COVID-19 vaccine in adolescent population receivedCovovaxtm (SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine) is the first protein-based COVID-19 vaccine authorized for adolescents ?12...

09:18
CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convideciatm) has been approved by the Ministry of Health Malaysia...

08:00
TripSitter Clinic Ltd. ("TripSitter" or the...


21 march 2022

22:34
Broncus(02216HK) today is pleased to announce that InterVapor® (including InterVapor Generator and InterVapor Catheter, the "InterVapor®"), the Company's thermal vapor treatment system, has been granted approval by the National Medical Products...


18 march 2022

03:18
Calliditas Therapeutics AB ("Calliditas") today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022. Everest received Breakthrough Therapy Designation (BTD) from the China...


17 march 2022

12:14
AbbVie , a research-based global biopharmaceutical company, announced Health Canada has approved SKYRIZI® (risankizumab), for the treatment of adult patients with...

09:32
On March 17, 2022, China National Drug Administration Drug Review Center (CDE) approved first Universal Chemeric Antigen Receptor T (UCAR-T) cell drug (Acceptance No. : CXSL2101509). CTA101 is independently developed by Nanjing Bioheng Biotech Co.,...

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 Health Canada has...


14 march 2022

04:22
The Ministry of Health, Labour and Welfare (MHLW) has granted regulatory approval of Guardant360® CDx, a liquid biopsy test for tumor mutation profiling, also known as comprehensive genomic profiling (CGP), in patients with advanced solid cancers....

02:25
Asieris Pharmaceuticals (688176.SH), a global innovative biopharma company specializing in discovering and developing innovative drugs for the treatment of genitourinary tumors and other major diseases, announced that the Hainan Provincial Medical...


10 march 2022

08:01
Servier, a global pharmaceutical company, today announced that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for TIBSOVO® (ivosidenib tablets) for two indications as a first line treatment, in...


9 march 2022

05:55
-  XPOVIO®, in combination with bortezomib and dexamethasone (XBd), gives patients with relapsed and/or refractory multiple myeloma, a new treatment option. -  XPOVIO®, in combination with dexamethasone (Xd), gives patients with triple class...


7 march 2022

22:49
Akeso, Inc. (9926.HK) ("Akeso"), a biopharmaceutical company dedicated to the development of innovative antibody drugs, today announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved...


2 march 2022

04:27
RedCloud Bio (the "Company"), an innovative biotech company integrating structural pharmacology and computational approaches to advance small molecule drug development, announced today that the US Food and Drug Administration (FDA) has accepted the...


1 march 2022

19:35
Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for cancer and other...


28 february 2022

02:00
Diadem Srl today announced CE IVD certification for its AlzoSure® Predict prognostic blood test for the early prediction of Alzheimer's disease (AD). The CE IVD (European Conformity In-Vitro Diagnostic Medical Devices) certification allows Diadem to...


27 february 2022

04:31
Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx® plant cell-based protein expression system, and...


25 february 2022

10:00
Brand Institute is proud to announce its successful partnership with Global Blood Therapeutics (GBT) in naming their EMA-approved therapy, OXBRYTA, indicated for the treatment of hemolytic anemia due to sickle cell disease (SCD) in adult and...


23 february 2022

08:32
Technology has become a lucrative part of the healthcare industry as providers increasingly realize the role it can play in helping them provide better care. For the architects and developers involved in creating these new, high-tech healthcare...


19 february 2022

05:37
CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convideciatm) has been approved by the Joint Prevention and Control...


17 february 2022

12:32
BIMZELX® (bimekizumab injection) is the first treatment for adults with moderate to severe plaque psoriasis that is designed to inhibit both IL-17A and IL-17F inhibitor to be approved by Health Canada. Approval is supported by three Phase III trials,...

11:35
Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has granted authorization for Nuvaxovidtm COVID-19 Vaccine (Recombinant...

11:30
Today, Health Canada authorized Novavax's Nuvaxovid COVID-19 vaccine for the prevention of COVID-19 in adults 18 years of age and older. This is the fifth COVID-19 vaccine authorized in Canada. After a thorough, independent review of the evidence,...


15 february 2022

09:00
TytoCare, the global health care industry's first all-in-one modular device and examination platform for AI-powered, on-demand, remote medical exams, announced today that it received CE Mark approval for its AI-backed Tyto Lung Sounds Analyzer. The...

08:00
Volpara Health is proud to announce that it has been granted a patent on a new method for the detection and quantification of breast arterial calcifications (BACs), by the US Patent and Trademark Office (patent number 11,246550). The method described...

02:05
AffaMed Therapeutics ("AffaMed"), a global clinical stage biotechnology company dedicated to developing and commercializing transformative pharmaceutical, digital and surgical products, today announced that the United States Food and Drug...


14 february 2022

16:02
Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Singapore Health Sciences Authority (HSA) has issued interim authorization for...

09:01
Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its submission to Swissmedic, the Swiss Agency for Therapeutic Products, for conditional...

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