News by subject: IMA

PHYTO-GENIOUS, a leading innovator in healthy aging solutions, has announced the launch of its revolutionary line of high-purity Nicotinamide Mononucleotide (NMN) products. By obtaining Natural Product Number (NPN) Licenses from Health Canada and...

On the heel of the regulatory meeting with Health Canada on March 31st 2023, CELL Technologies Inc. announces the submission of the clinical data of its stem cell program in pain for Health Canada approval. CELL is aiming to become the first...

INOVIO , a biotechnology company focused on developing and commercializing DNA medicines to help treat and protect people from HPV-related diseases, cancer, and infectious diseases, today announced that the European Committee for Orphan Medicinal...

Pie Medical Imaging, a global leader in cardiac imaging, announced it has received NINSHO Medical Device Certification for CAAS Qardia, their innovative echocardiography software platform....

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced that CT041, an autologous CAR T-cell product candidate against...

Syantra announced today that it has obtained CE marking for the Syantra DXTM Breast Cancer test. Syantra DXTM Breast Cancer is a minimally invasive blood test for the detection of an active breast cancer signature - in the earliest stages when it is...

HuidaGene Therapeutics (????; HuidaGene), a clinical-stage biotechnology company developing CRISPR-based programmable genomic medicine, announces that the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has...

?  Seventh approved indication for RINVOQ in the European Union (EU) and the first and only oral Janus Kinase (JAK) inhibitor approved to treat adult patients with moderately to severely active Crohn's disease ?  Third gastroenterology indication...

BioPhotas, Inc., the manufacturer of the award-winning Celluma SERIES of light therapy devices, announced today that the Company received certification to European Council Medical Device Regulation 2017/745 for low level light therapy devices. Over...

Alexion, AstraZeneca Rare Disease, today announced that Health Canada has granted a Notice of Compliance (NOC) for KOSELUGO (selumetinib) for the treatment of pediatric patients aged two years and above, with neurofibromatosis type 1 (NF1) who have...

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that the Denosumab solution for injection (trade name: MAILISHU, project code: 9MW0311), which is developed by its wholly-owned subsidiary...

ImmVira announced that its oncolytic virus product MVR-C5252 targeting malignant glioma obtained the approval from National Medical Products Administration ("NMPA") for Phase I clinical trial in China on March 29, 2023. Previously, MVR-C5252 also...

In cooperation with Oak Crest Institute of Science based in California, the H3D Foundation is pleased to announce the award of $721,209 USD in funding from the United States Agency for International Development (USAID) through MATRIX, a USAID project...

This approval allows the use of the IceSense3 disposable cryoprobes in combination with the Company's IceSense3 console, which was previously approved by the NMPAProducts to be distributed in China through agreement with Shanghai Medtronic Zhikang...

WuXi Biologics ("WuXi Bio") (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), congratulates its strategic partner Amicus Therapeutics ("Amicus") on receiving European Commission's approval for...

Prelude Corporation (PreludeDxtm), a leader in molecular diagnostics and precision medicine for early-stage breast cancer, today announced that the Centers for Medicare & Medicaid Services (CMS) has approved Advanced Diagnostic Laboratory Test (ADLT)...

OncoVent Co., Ltd. ("OncoVent"), a majority-controlled subsidiary of Shenzhen Hepalink Pharmaceutical Group Co., Ltd. (the "Company"), yesterday entered into a license agreement with Orient EuroPharma Co., Ltd. ("OEP"). According to the terms of the...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the European Medicines Agency (EMA) has validated the application for its self-developed anti-PD-1 mAb HANSIZHUANG (serplulimab), in combination with chemotherapy (carboplatin and etoposide),...

CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announced its 2022 Annual Results. Business Highlights Zevor-cel (CT053)...

Neogen Corporation announced today that the U.S. Environmental Protection Agency (EPA) has approved additional virucide claims to its Neogen® Viroxide Supertm disinfectant. These label claims specify that Neogen Viroxide Super kills viruses* on hard...

Lunit (KRX:328130.KQ), a leading global provider of AI-powered cancer solutions, today announced that its AI solution for 3D Breast Tomosynthesis (DBT) analysis, Lunit INSIGHT DBT, has met the requirements of the CE marking under Europe's latest...

According the latest data released at the Clinical Trials Implied Approval section on the website of China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences (hereinafter referred to as...

According the latest data released at the Clinical Trials Implied Approval section on the website of China's Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), Likang Life Sciences (hereinafter referred to as...

MedGuard Protection Plans (MedGuard), announces that its CEO, Sean Stapleton, has been selected to speak at the 2023 Medtrade Conference.  Since 1979, Medtrade has brought the Home Medical Equipment industry together to connect, share ideas, and...

Medtronic announced today that it has received CE (Conformité Européenne) Mark for the Afferatm Mapping and Ablation System, which includes the Sphere-9tm Catheter and the Afferatm Prism-1 Mapping Software. Together, the full system creates a new...

Cepheid today announced that Health Canada has issued Cepheid a medical device licence for Xpert® Xpress CoV-2 plus, a rapid molecular diagnostic test for qualitative detection of the virus that causes COVID-19.  ...

The European Medicines Agency has just granted an extension of the indication for the marketing authorisation for WAKIX® (pitolisant), which is now indicated for the treatment of narcolepsy in children from the age of 6 years, with or without...

GenFleet Therapeutics, a clinical-stage biotechnology company focusing on cutting-edge therapies in oncology and immunology, announced today that European Medicine Agency (EMA) approved the phase Ib/II study of GFH925 (KRASG12C inhibitor) in...

Mabwell (688062.SH), an innovative biopharmaceutical company with the layout of whole industry chain, announced that its IND application of its self-developed 9MW3811 injection for tumor and pulmonary fibrosis has been approved by the Therapeutic...

Ymmunobio, a preclinical stage biotech company specializing in the development of innovative treatments for cancer patients, announced today that it has been granted Orphan Drug Designation (ODD) by the US Food & Drug Administration (FDA) for YB-200,...

Natco Pharma (Canada) Inc., a subsidiary of Natco Pharma Limited, announced today the launch of PrNAT-POMALIDOMIDE Capsules, the first generic alternative to POMALYST® to be approved by Health Canada....

Dynavax Technologies Corporation , a biopharmaceutical company focused on developing and commercializing innovative vaccines, today announced that the United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA) has granted Marketing...

Servier, a global pharmaceutical company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for...

Karyopharm Therapeutics Inc. , a commercial-stage pharmaceutical company pioneering novel cancer therapies, and the Menarini Group ("Menarini"), a privately-held, leading international pharmaceutical company, today announced that the United Kingdom's...

Asieris Pharmaceuticals (688176), a global biopharma company specializing in discovering, developing and commercializing innovative drugs for the treatment of genitourinary tumors and other related diseases, announced that the registration...

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM)/ announces that the first patient has been enrolled in its Phase III clinical trial (NCT05438407) evaluating the investigational drug leniolisib, an oral, selective...

Global biotechnology leader CSL  today announced that the European Commission has granted conditional marketing authorization (CMA) for HEMGENIX® (etranacogene dezaparvovec), the first and only one-time gene therapy for the treatment of severe and...

GC Biopharma (006280.KS), a leading provider of biopharmaceutical products in South Korea, announced today that the World Health Organization (WHO) has granted prequalification for BARYCELA, GC Biopharma's varicella vaccine....

Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce that its portfolio therapy to treat rare soft tissue sarcomas has now been approved in New Zealand....

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) announces that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation...

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM) announces that the European Medicines Agency's (EMA) Committee for Human Medicinal Products (CHMP) has decided to shift its assessment of the Marketing Authorisation...

The first Chinese biosimilar approved in both China and the EU, and potentially to be approved in the U.S. -HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and...

Concept Medical Inc. (CMI), on 9th February 2023, received the Investigational Device Exemption (IDE) from the US FDA, for its Magic Touch Sirolimus Coated Balloon....

AcuraBio, a leading Australian biopharmaceutical contract development and manufacturing organization (CDMO), will provide a cGMP plasmid DNA CDMO service...

AcuraBio, a leading Australian biopharmaceutical contract development and manufacturing organization (CDMO), will provide a cGMP plasmid DNA CDMO service...

ProtonDx's Dragonflytm Respiratory Panel ? a rapid, accurate, and portable point-of-care molecular test that identifies multiple common respiratory pathogens - has been validated and approved for sale under the UK Health...

Help Therapeutics Co., Ltd. (hereinafter Help Therapeutics) has revealed that the China Center for Drug Evaluation (CDE) has approved the investigational new drug (IND) application of HiCM-188, a human (allogeneic) iPS cell-derived cardiomyocyte...

United Recovery Project provides a comprehensive range of services, including detoxification, inpatient treatment, outpatient programs, and post-treatment support, to ensure that clients have the necessary support to successfully recover from...

LAKE FOREST, Calif., Jan. 27, 2023 Infinity Neuro announced today that its Inspiratm aspiration catheters received CE Mark approval and are now commercially available in Europe. This is the first offering from Infinity Neuro which plans to launch a...

IceCure Medical Ltd. ("IceCure" or the "Company"), developer of minimally-invasive cryoablation technology, the ProSense® System that destroys tumors by freezing, today announced it has received a Notice of Allowance from...