Le Lézard

News by subject: IMA

1 2 3

21 january 2021

12:49
The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted a marketing authorization, for ELZONRIS (tagraxofusp) as monotherapy for the first-line treatment of...

12:37
Today, Bactiguard-coated Zimmer Biomet orthopaedic trauma implants received European regulatory clearance and CE mark. Preparations for registering the implants in the U.S. market are also ongoing. "I am very pleased that the CE mark has been secured...

11:36
The Menarini Group, a privately held Italian pharmaceutical and diagnostics company, announced today that the European Commission (EC) has granted a marketing authorization, for ELZONRIS (tagraxofusp) as monotherapy for the first-line treatment of...

07:00
Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. ("Bausch Health"), today announced that LUMIFY® (brimonidine tartrate ophthalmic solution 0.025%) redness reliever eye drops have received approval from the Ministry...


19 january 2021

07:00
Esaote North America announces that the MyLabtmX8 Ultrasound System has now been approved in Canada. Previously approved by FDA in...


18 january 2021

08:00
ImmunoFlextm, a life sciences company developing clinically validated, pharmaceutical grade natural health products based on advancements in genomics research, today announced the approval of FLEX 10tm by Health Canada. "At ImmunoFlex, we work with...


15 january 2021

10:29
The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the approval of the Russian Sputnik V vaccine against coronavirus by the Ministry of Health of the Republic of Paraguay....


13 january 2021

08:00
Gracell Biotechnologies Inc. ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, has been granted approval for a pivotal seamless Phase...

07:30
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has approved IMBRUVICA® (ibrutinib) in combination with rituximab for the treatment of patients with previously untreated chronic lymphocytic leukemia...


12 january 2021

16:00
Incyte and MorphoSys AG today announced that Health Canada has accepted the New Drug Submission (NDS) for tafasitamab, an anti-CD19 antibody. The application seeks approval of tafasitamab in combination with lenalidomide, followed by tafasitamab...

14:15
Lundbeck is pleased to announce that VYEPTI® (eptinezumab) has been approved by Health Canada for the preventive treatment of migraine in adults who have at least 4 migraine days per month....

07:00
Bristol Myers Squibb Canada (BMS) announced today that Health Canada has approved ONUREG® (azacitidine tablets) for use as the first and only maintenance therapy for adult patients with acute myeloid leukemia (AML) who achieved complete remission...


6 january 2021

12:13
The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by State Agency for Medicines and Health Technologies (Agencia Estatal De Medicamentos Y...


5 january 2021

08:26
KYE Pharmaceuticals Inc. ("KYE"), a private company headquartered in Mississauga, Ontario focused on bringing medicines that fulfill clinically significant unmet needs to the Canadian market, today announced an important milestone,...


28 december 2020

10:00
Brand Institute, the global leader in pharmaceutical and healthcare related name development, is proud to announce its role in naming Pfizer and BioNTech's COVID-19 vaccine: COMIRNATY® (koe mir' na tee). The name was first announced by Swiss...

08:00
Vertex Pharmaceuticals Incorporated  today announced its New Drug Submission for TRIKAFTA®, Vertex's investigational triple combination medicine, has been accepted for Priority Review by Health Canada for the treatment of cystic fibrosis (CF) in...


23 december 2020

13:07
The Russian Direct Investment Fund (RDIF, Russia's sovereign wealth fund) announces the registration of the Russian Sputnik V vaccine against coronavirus by The National Administration of Drugs, Foods and Medical Devices of Argentina (ANMAT)....

01:25
Halozyme Therapeutics, Inc. today announced that the European Commission has approved Roche's Phesgo®, a fixed-dose combination of Perjeta® (pertuzumab) and Herceptin® (trastuzumab) with Halozyme's ENHANZE® technology, administered by subcutaneous...


22 december 2020

23:30
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, today...


21 december 2020

07:30
Medtronic Canada ULC, a subsidiary of Medtronic plc announced today that it has received a Health Canada licence for Micratm AV, the world's smallest pacemaker with atrioventricular (AV) synchrony. Micra AV is indicated for the treatment of patients...


18 december 2020

17:21
Garching - OncoBeta® GmbH and their subsidiary OncoBeta Therapeutics Pty Ltd. Australia a Medical Device Company specialized in innovative epidermal radioisotope therapies for Non-Melanoma Skin Cancers (NMSCs), announced today that the Rhenium-SCT...


16 december 2020

20:30
Yiling Pharmaceutical discloses on Wednesday that it has received the Approval of Registration approved and issued by the Medicines Control Authority of Zimbabwe, which indicates that the Company's patented product of "Lianhua Qingwen Capsules" meets...


8 december 2020

08:30
Medtronic Canada ULC, a subsidiary of Medtronic plc ? the world's largest medical technology, services, and solutions company ? has received a licence from Health Canada for its MiniMedtm 770G insulin pump system. This is currently the only insulin...

08:00
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid...

03:00
Shanghai Henlius Biotech, Inc. (2696.HK) announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid...


7 december 2020

15:45
Acuva Technologies Inc. ("Acuva"), today announced successful validation of the Acuvatm SOLARIS handheld disinfecting wand against SARS-CoV-2 (COVID-19). The test report confirms that a >99.97% level of disinfection was achieved in 10 seconds....


2 december 2020

05:25
Regent Pacific Group Limited ("Regent Pacific" or the "Company" and together with its subsidiaries, the "Group"; stock code: 0575.HK), a specialist healthcare, wellness and life sciences investment group is pleased to announce that Wanbang...

03:00
European based company Selfdiagnostics (GER, EST) plans to submit request for authorisation of its molecular diagnostic test for home and for point of care use ? to detect the coronavirus SARS-CoV-2. Selfdiagnostics rapid PCR is first multifunctional...


1 december 2020

09:07
Diabeloop announced today that it has obtained CE marking for its innovative and adjustable technological solution: DBL-hu.DBL-hu improves glycemic control and satisfaction for people living with a form of diabetes that is very complex to...

07:00
Gilead Sciences Canada, Inc. (Gilead Canada) today announced that Health Canada has granted a Notice of Compliance (NOC) for DESCOVY® (emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets) for Pre-Exposure Prophylaxis (PrEP) to reduce the...


23 november 2020

09:00
Rapid Medical, a company focused on the development of next-generation neurovascular devices, has announced CE Mark approval for the expanded indication of Comaneci to treat cerebral vasospasm. Comaneci is the first adjustable remodeling mesh device...

04:00
Rapid Medical, a company focused on the development of next-generation neurovascular devices, has announced CE Mark approval for the expanded indication of Comaneci to treat cerebral vasospasm. Comaneci is the first adjustable remodeling mesh device...


20 november 2020

16:23
Health Canada today granted authorization under the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 for the use of bamlanivimab (LY-CoV555) as a treatment for adults and pediatric patients 12...


16 november 2020

07:30
Aruvant, a clinical-stage biopharmaceutical company focused on developing and commercializing transformative gene therapies for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted orphan designation...


10 november 2020

08:00
AbbVie , a global, research and development-based biopharmaceutical company announced today that Health Canada has approved a label change for MAVIRET®...


4 november 2020

13:00
Precision Biomonitoring announced today it has received Health Canada approval for its ready-to-use thermostable SARS-CoV-2 TRIPLELOCKtm Test Strips for use across Canada. The TRIPLELOCKtm Test Strips are a rapid, point-of-need diagnostic...


3 november 2020

18:01
The Valens Company Inc. (the "Company" or "The Valens Company"), a global leader in the end-to-end development and manufacturing of innovative, cannabinoid-based products, today announced that the Victoria State Government in Australia has granted...


2 november 2020

08:00
Global biotherapeutics leader CSL Behring announced today that its investigational, plasma-derived hemopexin therapy (CSL889) received orphan drug designation from both the European Commission and the U.S. Food and Drug Administration (FDA) Office of...

05:00
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its new VITROS® SARS-CoV-2...


29 october 2020

15:11
Medtronic Canada ULC, a subsidiary of Medtronic plc ? the world's largest medical technology, services, and solutions companies ? announced today that it has received a Health Canada licence for the Percepttm PC Deep Brain Stimulation (DBS) system...


28 october 2020

09:00
Medasense Biometrics Ltd. announced today that its NOL® pain response monitoring device (PMD-200tm) has been approved for marketing in Brazil by ANVISA, the Brazilian health regulatory agency. Medasense's NOL technology enables clinicians to optimize...

07:35
Insmed Incorporated , a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced that the European Commission (EC) has granted marketing...


27 october 2020

13:09
The Russian Direct Investment Fund, (RDIF, Russia's sovereign wealth fund), has submitted applications to the World Health Organization (WHO) for accelerated registration (Emergency Use Listing, EUL) and prequalification of the world's first...


26 october 2020

19:32
Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, today announced that its new VITROS® SARS-CoV-2 Antigen test, designed to detect active SARS-CoV-2 infection, achieved CE Mark for distribution throughout the EU. The company also...

09:00
Incyte today announced that Health Canada has accepted its New Drug Submission (NDS) for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor, as a treatment for adults with previously treated, unresectable, locally advanced...

07:30
Kantaro Biosciences, LLC (Kantaro), a joint venture between the Mount Sinai Health System and RenalytixAI (LSE:RENX / NASDAQ: RNLX), and...

07:00
CollPlant a regenerative and aesthetic medicine company, today announced that it has received a substantial first order totaling hundreds of thousands of U.S. dollars for its Vergenixtm Flowable Gel (FG) product in Ukraine from CollPlant's new...


21 october 2020

01:00
Pharming Group N.V. (Euronext Amsterdam: PHARM) today announced that the European Commission has granted orphan drug designation for leniolisib for the treatment of activated phosphoinositide 3-kinase delta syndrome (APDS),...


19 october 2020

15:15
Isla Pharmaceuticals, a US-based company focused on rational repurposing of molecules for the treatment or prevention of viruses is pleased to announce that a key patent relating to the Company's lead program, Isla101 has been granted by the...

07:00
COVID-19 has fundamentally changed the world, but it has also undeniably led to an acceleration of driving new progressive technology. For instance, Cloud computing, AI and Automation is making existing processes ? in response to more strained global...

1 2 3