News by subject: IMA

Thorne HealthTech, Inc. ("Thorne HealthTech" or "Thorne") , a leader in developing innovative solutions for a personalized approach to health and wellness and majority owner of Drawbridge Health announced today that its OneDrawtm Blood Collection...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Turkish Ministry of...

-- Ascletis is China's first biotech company which has obtained IND approvals of an oral RdRp inhibitor from both China NMPA and the U.S. FDA -- Ascletis has filed multiple patent applications for ASC10 and its use globally. Compared with...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products, announced today that the Center for Drug Evaluation (CDE) of China's...

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+/HER2- advanced or metastatic breast cancer in the European...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval for Nuvaxovidtm...

CorDx, a global leader in the development, manufacturing, and distribution of diagnostics and medical devices, was recently granted a CE Mark certificate for two of the company's monkeypox diagnostic tests. The CE Mark, granted on May 23, 2022,...

Edwards Lifesciences Corporation , today announced the company's PASCAL Precision transcatheter valve repair system received CE Mark for the treatment of mitral and tricuspid regurgitation (MR and TR)....

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that New Zealand's Medsafe has granted expanded provisional approval...

CytoSorbents Corporation , a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced that the Israeli Ministry of...

Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved KORSUVA (difelikefalin) injection for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing...

Medison Pharma ("Medison"), a global pharma company focused on providing access to highly innovative therapies to patients in international markets, announced today the expansion of its partnership with Albireo to a multi-regional agreement to...

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 that...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Nuvaxovidtm (NVX-CoV2373) COVID-19 vaccine received expanded manufacturing and...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the Australian Therapeutic Goods Agency (TGA) has granted expanded approval for provisional...

RINVOQ (upadacitinib) is now approved by the European Commission for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response or were intolerant to either conventional...

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

Anti-PD-1 monoclonal antibody ? PuyouhengTM (HX-008, pucotenlimab injection), was conditionally approved by the National Medical Products Administration (NMPA) for marketing in China to treat patients with unresectable or metastatic microsatellite...

AbbVie , today announced that Health Canada has approved RINVOQ® (upadacitinib, 15 mg), the first oral, once-daily selective and reversible JAK inhibitor for the treatment of adults with active ankylosing spondylitis (AS) who...

Eiger BioPharmaceuticals Inc. , a commercial-stage biopharmaceutical company focused on the development of innovative therapies to...

On July 13 2022, Simcere Pharmaceuticals (02096.HK) announced that the China National Medical Products Administration (NMPA) has conditionally approved COSELA® (trilaciclib hydrochloride for injection), an innovative myeloprotection drug jointly...

Neurophth Therapeutics, Inc., ("Neurophth") today announced that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has granted a Breakthrough Therapy Designation (BTD) to the Company's leading gene therapy...

Today, Health Canada authorized the use of the Moderna Spikevax COVID-19 vaccine in children 6 months to 5 years of age. This is the first COVID-19 vaccine authorized in Canada for use in this age group and marks a milestone in Canada's response to...

On July 11, 2022, VenusP-ValveTM, Venus Medtech's in-house developed innovative transcatheter pulmonic valve replacement (TPVR) system, was approved by China's National Medical Products Administration (NMPA) for the treatment of severe pulmonary...

GenScript Biotech (Netherlands) BV, a subsidiary of GenScript Biotech Corporation ("GenScript", Stock Code: 1548.HK), a world-leading biotechnology company, announced that its SARS-CoV-2...

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...