News by subject: IMA

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...

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 it has received regulatory...

PTC Therapeutics, Inc. today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Evaluation Document recommending Translarnatm (ataluren) for reimbursement and use across the National Health Service (NHS)...

Celltrion Healthcare Canada Limited today announced that Health Canada granted a notice of compliance (NOC) on...

Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA) is pleased to announce a positive recommendation from the CADTH Canadian Drug Expert Committee (CDEC) for RADICAVA® Oral Suspension, the...

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...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that partner SK bioscience has received expanded manufacturing and marketing approval from...

AffaMed Therapeutics ("AffaMed"), a global clinical stage biopharmaceutical company dedicated to address critical unmet medical needs in neurological, psychiatric and ophthalmic...

Ultomiris (ravulizumab) has been approved in Canada for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR)...

Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection),...

Dizal (SHEX: 688192) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for sunvozertinib for the treatment of advanced NSCLC with EGFR...

SK bioscience, a global innovative vaccine and biotech company committed to promoting human health from prevention to cure across the globe, announced that the company has received a biologics license...

BioMarin Submits Supplemental New Drug Application to U.S. Food and Drug Administration to Expand Label to Treat Children with Achondroplasia Under the Age of 5 Submissions Based on Favorable Results from Global Randomized Phase 2 Study in Infants...

ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, announced that 1) dosing has initiated in the Phase 1 first-in-human...

Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (FRA: JAM1) a leader in cannabinoid-derived drug discovery and development is providing its shareholders with another regulatory update on the REDUVOtm New Drug Submission (NDS). The last update was...

IASO Biotherapeutics (IASO Bio), a clinical-stage biopharmaceutical company engaged in discovering, developing, and manufacturing innovative cell therapies and antibody products,, today announced that the Investigational New Drug (IND) application...

First automated insulin delivery (AID) system in the world to work with Abbott's FreeStyle Libre® 3 sensorAutomated process streamlines and improves daily diabetes management for people who are on insulin therapy1Hybrid closed-loop system mylifetm...

Sobi® and ADC Therapeutics SA today announced that the European Commission (EC) has granted conditional marketing authorisation for the use of Zynlonta® (loncastuximab tesirine) for the treatment of relapsed or refractory diffuse large B-cell...