News by subject: IMA

Vertex Pharmaceuticals Incorporated (Canada)  today announced that it has signed a Letter of Intent (LOI) with the pan-Canadian Pharmaceutical Alliance (pCPA), which represents an agreement in principle regarding the public reimbursement of...

Fairtilitytm, the transparent AI innovator powering in vitro fertilization (IVF) for improved outcomes, today announced its AI decision support tool CHLOE EQtm earned the CE Mark under the European Medical Devices Regulation (MDR) regulatory...

Immunovia AB announced, that Immunovia, Inc., its American subsidiary, has recently received approval for a Current Procedural Terminology (CPT) Proprietary Laboratory Analyses (PLA) code from the American Medical Association (AMA) for the IMMraytm...

Arctic Vision, a China-based biotech company focused on innovative ophthalmic therapies, today announced that the first patient has been enrolled in a Phase III clinical study evaluating...

Pfizer Canada announces today that Health Canada has approved CIBINQO® (abrocitinib) for the treatment of patients 12 years and older with refractory moderate to severe atopic dermatitis, including the relief of pruritus, who have had an inadequate...

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...

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...

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...

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...

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...

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

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...

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,...

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...

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

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...

-- 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...

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...

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...

? 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...

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...

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...

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,...

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...

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...

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

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...

- 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...

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),...

Braxia Scientific Corp....

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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...

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

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...

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...

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...

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...

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...

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...