Le Lézard

News by subject: IMA

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12 december 2023

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


11 december 2023

12:27
Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for...

11:45
The marketing authorisation (MA) for Eluciremtm (Gadopiclenol) was granted to Guerbet by the European Commission based on the positive opinion of the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) dated 12 October...

07:00
Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its submission to the Center for Drug Evaluation (CDE) of the National Medical Products Administration for the "A Randomized, Open-label,...


5 december 2023

16:01
Novavax, Inc. , a global company advancing protein-based vaccines with its Matrix-Mtm adjuvant, today announced that Health Canada has granted expanded authorization for Nuvaxovidtm XBB.1.5 Vaccine (Recombinant protein, Adjuvanted) (NVX-CoV2601) for...

03:30
Mission Therapeutics ("Mission" or the "Company"), a clinical-stage biotech developing first-in-class therapeutics targeting...


24 november 2023

06:57
23 Nov, 2023, on the second anniversary of the initial approval for olverembatinib, Ascentage Pharma hosted a ceremony in Suzhou, China, marking the launch of olverembatinib in a newly approved indication and the dispatch of the first batch of the...


23 november 2023

23:44
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 China's National Medical Products...

19:38
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...


22 november 2023

22:37
EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to commercialise (150 mg, for intravenous use) had received a marketing authorization from the European Commission...


21 november 2023

14:22
Huma's platform is ready to use, reducing the time and cost for other companies to bring regulated SaMD products to market, democratising digital health innovation across the industryClass C certification expands the patient population and level of...

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 U.S. Food and Drug Administration has approved its Phase II IND...


17 november 2023

10:19
Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent attacks of...


13 november 2023

16:30
Johnson & Johnson MedTech* today announced that the MONARCH Platform and MONARCH Bronchoscope have obtained regulatory approval in China. The platform is the first minimally invasive, robotic-assisted technology approved for peripheral lung...


10 november 2023

08:00
ARUP Laboratories today announced that it has gained the Conformité Européenne (CE) mark for AAV5 DetectCDxtm single-site use under the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR). AAV5 DetectCDxtm is a companion diagnostic...


8 november 2023

07:00
CASI Pharmaceuticals Inc. , a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, is thrilled to announce a major milestone in its partnership with Juventas Cell Therapy Ltd....


7 november 2023

02:50
Executives of many multinational companies have expressed their confidence in the Chinese market and vowed to further expand their businesses in the country, as they explore opportunities at the ongoing China International Import Expo (CIIE) in...


2 november 2023

16:31
Lilly Canada is pleased to announce that Mounjaro®...

09:26
Gedeon Richter Plc. ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland, GmbH ('SMPS') today announce that the European Commission ('EC') has granted approval of a Type II Variation application for RYEQO®...


1 november 2023

07:00
Ultomiris (ravulizumab) has been approved by Health Canada as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder...


31 october 2023

20:30
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,...

18:00
Syqe Medical, a global leader in innovative medical inhalation technology, together with Australian sponsor and distribution partner Novachem, is pleased to announce a significant milestone in its mission to improve the lives of patients worldwide....

16:37
Novavax, Inc. , a global company advancing protein-based vaccines with its Matrix-Mtm adjuvant, today announced the...


30 october 2023

11:00
AIRS Medical...


27 october 2023

01:05
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 the Pharmaceutical Administration...


26 october 2023

04:00
Aidoc today announced a pioneering collaboration with the Pulmonary Embolism Response Team (PERT) at UZ Brussel (UZB), becoming the first European hospital to use AI for cross-departmental care coordination, expediting treatment for suspected...


25 october 2023

07:30
Merck , known as MSD outside the United States and Canada, and Eisai announced today that KEYTRUDA®, an anti-PD-1 therapy, in combination with LENVIMA®, the multiple receptor tyrosine kinase inhibitor discovered by Eisai, is reimbursed under the...


24 october 2023

02:00
TLV assesses the severity of advanced hormone-sensitive prostate cancer as high1.The condition is progressive and carries a risk of developing metastatic castration-resistant prostate cancer (mCRPC), which is associated with a greatly shortened...


23 october 2023

09:00
WAT Medical Enterprise Ltd. has extended its support to two prominent institutions: the Canadian Red Cross and Peach Arch Hospital, through monetary donations....

01:30
Nanoform Finland Plc. (Nanoform), an innovative nanoparticle medicine-enabling company today announced that it has granted AstraZeneca Plc a global online STARMAP® license. STARMAP® is a digital AI version of the CESS® technology that enables...


19 october 2023

07:30
Sumitomo Pharma Canada, Inc. and Pfizer Canada today announced that Health Canada has granted a Notice of Compliance (NOC) for MYFEMBREE (Relugolix, estradiol and norethindrone acetate tablets) for the management of moderate to severe pain associated...

05:45
Skyline Therapeutics, an innovation-driven gene therapy company committed to developing unique and novel solutions for rare and severe diseases, today announced that the China National Medical Products Administration (NMPA) has approved its...


18 october 2023

08:32
RTI International, a nonprofit research institute and leading international development organization, joins the Lao People's Democratic Republic (Lao PDR), World Health Organization, and the U.S. Agency for International Development (USAID) in...

08:00
Novavax, Inc. , a global company advancing protein-based vaccines with its Matrix-Mtm adjuvant, today announced that Singapore's Health Sciences Authority (HSA) has granted full approval for Novavax's prototype COVID-19 vaccine Nuvaxovidtm...


17 october 2023

07:00
AbbVie , today announced that EPKINLYtm (epcoritamab injection/epcoritamab for injection) has received Health Canada authorization with conditions. It is the first and only subcutaneous (SC) T-cell engaging bispecific antibody for the treatment of...


16 october 2023

08:00
Dalan Animal Health, Inc. ("Dalan"), the pioneering biotech company specializing in insect health, today announced it has received market authorization from the Canadian Center for Veterinary Biologics (CCVB) under the Canadian Food Inspection Agency...


13 october 2023

10:00
Geneseeq Technology Inc. announced on Thursday that Geneseeq's Non-Small Cell Lung Cancer Tumor Mutational Burden Test Kit (Reversible terminator sequencing method) (NSCLC TMB Kit) has gained approval from the Chinese National Medical Products...


12 october 2023

20:22
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China National Medical...


11 october 2023

05:20
Kintor Pharmaceutical Limited ("Kintor Pharma", HKEX: 9939), a clinical-stage biotechnology company developing innovative small molecule and biological therapeutics, today announced that its Hedgehog/SMO inhibitor GT1708F had obtained conditional...


3 october 2023

15:50
Novavax, Inc. , a global company advancing protein-based vaccines with its novel...

04:23
Calliditas Therapeutics AB (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the...

04:20
Calliditas Therapeutics AB (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the...


28 september 2023

14:34
The updated vaccine (XBB.1.5 variant-adapted monovalent COVID-19 vaccine) is now authorized in Canada for individuals 6 months of age and olderThe updated vaccine is administered as a single dose for individuals 5 years of age and older, regardless...


27 september 2023

08:30
Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments is excited to announce that a physician has been authorized to receive APEX-90 macrodose psilocybin drug product...


25 september 2023

01:46
BioArctic AB's (publ) partner Eisai announced today that "LEQEMBI® Intravenous Infusion" (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to...


21 september 2023

17:41
Jazz Pharmaceuticals plc today announced that the European Commission (EC) has granted marketing authorization for Enrylaze® (JZP458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic...


19 september 2023

16:49
Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVisiontm AI-powered lung navigation and real-time imaging platform has been granted certification as a Class IIa medical device under the...


18 september 2023

08:05
CELL Technologies Inc. is pleased to announce the award of a No Objection Letter (NOL) from Health Canada to launch the first ever pivotal stem cell program in pain and Osteoarthritis in the world....

06:00
Field Medical, Inc. (Field Medical), an emerging leader in cardiac catheter ablation, announced today that it has closed its oversubscribed seed round with investments totaling $14M.  The convertible note funding was led by private investors who...


15 september 2023

10:44
Gedeon Richter Plc. ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland GmbH ('SMPS') today announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency...

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