Le Lézard

News by subject: IMA

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30 june 2022

13:40
Asciminib final draft recommended by the National Institute for Health and Care Excellence (NICE) for use for treatment of adult patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase (CP), previously...


29 june 2022

07:00
Seegene Inc. (KQ096530), South Korea's leading molecular diagnostics (MDx) company, has obtained EU approval for its Allplextm SARS-CoV-2/FluA/FluB/RSV Assay that is compatible with the company's fully automated 'AIOS' (All-in-One System). This is...


28 june 2022

11:25
Today, Bristol Myers Squibb Canada (BMS) announced Health Canada has issued a Notice of Compliance with Conditions (NOC/c) for OPDIVO®, as a monotherapy for the adjuvant treatment of adult patients with urothelial carcinoma (UC) who are at high risk...

08:39
Healthtech leader Eon is pleased to welcome Eric D. Newman, MD, as Chief Innovation Officer. Dr. Newman spent 35 years with the Geisinger Health System in a variety of capacities, recently retiring as the Director of Quality and Innovation for their...


27 june 2022

02:33
Jiangsu Recbio Technology Co., Ltd. is pleased to announce that, the Group has recently received the clinical trial approval (the"Clinical Trial Approval") for its R520A, a mRNA COVID-19 vaccine ("R520A"), from the Food and Drug Administration of the...


24 june 2022

07:15
BioMarin Pharmaceutical Inc. announced today that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive...


13 june 2022

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 oncology, autoimmune, metabolic, ophthalmology and other major...

11:09
Asep Medical Holdings Inc. ("Asep Inc." or the "Company")   is pleased to announce that the Company has received an official allowance of its patent claims that serve as the foundation underlying their first-generation sepsis diagnostic technology,...


9 june 2022

22:57
Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products to address critical unmet needs in Asia Pacific markets, announced today...

08:33
LumiraDx Limited , a next-generation point of care diagnostics company, today announced that it has achieved CE Mark for...

08:00
IceCure Medical Ltd. ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System, that destroys tumors by freezing as an alternative to surgical tumor removal ("ProSense"), today announced that...


8 june 2022

08:10
-- ASC42 has completed Phase I trials in the U.S. and China. This approval from U.S. FDA enables Gannex to complete a critical drug-drug interaction (DDI) study to support upcoming Phase III trials in China, the U.S. and European Union -- Gannex...

06:03
LumiraDx Limited today announced that it has achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. These high-sensitivity and high-throughput tests...

05:00
Procleix Plasmodium Assay is a nucleic acid test (NAT) that detects the presence of Plasmodium, a protozoan parasite that causes malaria worldwide and creates a significant risk for both blood safety and availabilityScreening blood donors with the...


6 june 2022

23:27
? Discovered in-house by the internal R&D Team at Antengene, ATG-018 is an orally-bioavailable, small molecule ataxia telangiectasia and Rad3-associated (ATR) kinase inhibitor that targets the DNA damage response (DDR) pathway.? This Phase I study...

00:23
The National Medical Products Administration approved sugemalimab for the treatment of patients with unresectable stage III non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based...


1 june 2022

14:05
Takeda UK Ltd. is pleased to announce that NICE has recommended the use of Revestive® ? (teduglutide) once daily subcutaneous injection as an option for people living with Short Bowel Syndrome (SBS) aged 1 year and above, within their final appraisal...

07:49
Burning Rock Biotech Limited announced that it has received CE marking for its OverCtm Multi-Cancer Detection Blood Test manufactured in both the US and China facilities (Identification Number: DE/CA20/01-IVD-Luxuslebenswelt-523/22,...


31 may 2022

13:36
Foresee Pharmaceuticals (6576.TWO), ("Foresee") announced today that the European Commission (EC) has approved the Marketing Authorization Application (MAA) for CAMCEVI® 42 mg prolonged-release suspension for injection, for the treatment of...

08:00
VolitionRx Limited ("Volition"), a multi-national epigenetics company, has announced that its Nu.Q® NETs test has been CE marked for the detection and evaluation of NETosis, enabling clinical use in more than 27 countries across Europe. NETosis is a...


27 may 2022

04:50
Ahead of World Digestive Health 2022, Italian pharmaceutical group Alfasigma is proud to announce the launch of its new...


25 may 2022

08:30
SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (ConformitéEuropéenne) Mark approval for SeekInClarityTM Cancer Treatment Response Monitoring Kit and is now ready to launch this test in...

04:41
- Pfizer will provide all its current and future patent-protected medicines and vaccines available in the U.S. or EU on a not-for-profit basis to 45 lower-income countries. - Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to...


24 may 2022

06:59
Bausch + Lomb Corporation ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, today announced that Health Canada has approved LUMIFY® (brimonidine tartrate ophthalmic solution 0.025% w/v),...


20 may 2022

07:45
Braxia Scientific Corp....

05:15
LumiraDx Limited , a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization...


19 may 2022

10:52
CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that the World Health Organization ("WHO") has granted Emergency Use Listing ("EUL") for Convideciatm, CanSinoBIO's Recombinant Novel Coronavirus Vaccine (Adenovirus...


16 may 2022

09:00
UL, a global safety science leader, today announced that Walgreens, an integrated healthcare pharmacy and retail leader, has earned a UL Verified Mark. This year, the UL Verified Mark will begin appearing on Walgreens brand vitamins and...

07:30
With this approval, Benuvia has begun focusing on four primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine (5-MeO DMT), Dimethyltryptamine (DMT), and 3,4-Methylenedioxymethamphetamine, or MDMABenuvia will manufacture...

02:25
Faron Pharmaceuticals Ltd. ("Faron" or "Company") Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies Phase 1 dose escalation study...


15 may 2022

22:47
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...


13 may 2022

14:45
Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), announced today that Health Canada has accepted the filing of a Supplement to a New Drug Submission (SNDS) for an investigational oral...


12 may 2022

10:43
Yiling Pharmaceutical disclosed Wednesday that it had received the medicine approval document for Lianhua Qingwen Capsules from the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria. The Product Category is Herbal and...


7 may 2022

11:08
Recently, The SARS-CoV-2 Antigen Nasal Test Kit(self-test) independently developed by Assure Tech (Hangzhou) Co., Ltd . (hereinafter referred to as " Assure Tech ") has obtained the EU CE certification. The product can be sold across EU countries and...


2 may 2022

08:40
Vitti Labs, an AATB Accredited Tissue Bank focused on life Science Research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) to move...


28 april 2022

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...


27 april 2022

15:25
Seeking to bolster its development of a biocompatible graft that promises to reshape the future of cardiac bypass surgery, Medical 21, a medtech device company, today announced it has filed a Form 1-A preliminary offering circular...


21 april 2022

07:50
icometrix, the worldwide leader in digital health technology solutions for neurological conditions, announced the recent release of a Medtech Innovation Briefing (MIB) [MIB291] from the internationally renowned NICE for the CE markers and FDA cleared...


20 april 2022

15:12
Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved Tavneos® (avacopan), an orally administered selective complement 5a receptor...


19 april 2022

07:15
Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that its partner, Takeda,  received manufacturing and marketing approval from the...


14 april 2022

11:04
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination has received a Notice of Compliance from Health Canada for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (?12 years...


12 april 2022

19:32
Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies announced today that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the...

11:51
Apotex Corp. announced today its release of Paclitaxel protein-bound particles for injection (albumin-bound), a generic version of Abraxane® in the United States. Paclitaxel protein-bound particles for injectable suspension is indicated for the...


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...

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