News by subject: IMA

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...

SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (Conformité Européenne) Mark approval for PanCanSeek® Cancer Mutation Detection Kit and is now ready to launch this test in European Union and...

Atara Biotherapeutics, Inc. , and Pierre Fabre today announced that the European Commission (EC) has granted marketing authorization for...

Jacobio Pharma (1167. HK) announced that the Company's in-house KRAS G12C inhibitor JAB-21822 was granted breakthrough therapy designations for the second line and above treatment of advanced or metastatic non-small cell lung cancer (NSCLC) patients...

Approval based on direct-to-Phase 3 program showing more than three times as many Dupixent patients (60% and 58%) experienced clinically meaningful itch reduction at 24 weeks compared to placebo (18% and 20%) Dupixent also significantly reduced skin...

Today, Health Canada authorized the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent-adapted booster for use in children 5 to 11 years of age. This is the first bivalent COVID-19 booster authorized for use in this age group that targets the...

QurAlis Corporation, a...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has approved a supplement to a New Drug Submission (sNDS) for Nuvaxovidtm...

PTC Therapeutics, Inc. announced today that the Brazilian Health Regulatory Agency, ANVISA (Agência Nacional de Vigilância Sanitária), has approved Waylivratm (volanesorsen) as the first treatment for familial partial lipodystrophy (FPL) in Brazil....

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the World Health Organization (WHO) has issued an updated Emergency Use Listing (EUL)...

Bristol Myers Squibb Canada (BMS) today announced that Health Canada has approved SOTYKTU (deucravacitinib tablets), the first-in-its-class oral tablet for the treatment of adult patients with moderate to severe plaque psoriasis who are candidates...

SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (Conformité Européenne) Mark approval for SeekInCure® Cancer Recurrence Monitoring Kit and is now ready to launch this test in European Union and...

Everest Medicines (HKEX: 1952.HK), a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical...

-        Third approved indication for SKYRIZI® (risankizumab) and the first specific IL-23 inhibitor for the treatment of Crohn's disease in the European Union (EU) -        A significantly higher proportion of patients on SKYRIZI achieved clinical...

Immorna, a rapidly expanding biotechnology company, focusing on the development of multi-platform RNA-based therapeutics and vaccines, today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND)...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has granted expanded authorization for Nuvaxovidtm (COVID-19 Vaccine...

Emmaus Life Sciences, Inc. , a leader in sickle cell disease treatment, announced today that it has been issued a Registration Certificate from the Registration Committee for Pharmaceutical Companies & their Products of the Qatar Ministry of Public...

See-Mode Technologies, a MedTech company based in Australia that is on a mission to unlock the hidden insights within medical imaging, today announced that it has received approval from Health Canada for its product expansion to support Breast &...

PTC Therapeutics, Inc. today announced that Upstazatm (eladocagene exuparvovec) was granted authorization by the Medicines and Healthcare Products...

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for the in-house developed oral PD-L1...

WuXi Vaccines, a leading global Contract Development and Manufacturing Organization (CDMO), announced that it has entered into an agreement with Harbour BioMed under which Harbour BioMed's manufacturing facility in Suzhou will be transferred to WuXi...

SIME Diagnostics, a pioneer in point-of-care respiratory diagnostics in the ICU, today announced the successful CE-IVD accreditation of the world's first Clinical AI Platform for the rapid prediction of severe respiratory disease. The CE marked...

Akeso, Biopharma (9926. HK) ("Akeso") announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has granted Breakthrough Therapy Designation (BTD) for Ivonescimab (PD-1/VEGF bispecific antibody,...

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Medicines Agency's Committee for...

J INTS BIO announced on November 9th that it had received approval from the US FDA for its Phase 1/2 clinical trial of its Novel Oral 4th Generation EGFR TKI 'JIN-A02' in patients with advanced non-small cell lung cancer (NSCLC)....

Caption Health, the leader in using AI and services to improve access to heart ultrasound diagnostics, announced new regulatory approvals to market its Caption AItm technology platform from Health Canada's Medical Devices Directorate and Australia's...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom...

Organon , a global women's health company, is announcing the launch and product availability of Aybintio®, a biosimilar of Avastin®, providing a new treatment option for adult Canadian patients affected with certain aggressive forms of cancers,...

Shanghai Henlius Biotech, Inc. (2696. HK) announced that its first self-developed innovative anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (generic name: serplulimab injection), in combination with carboplatin and albumin-bound paclitaxel for the...

MIM Software Inc., a leading global provider of medical imaging software, announced today it has received approval from Health Canada for its AI auto-contouring solution, Contour ProtégéAItm....

Broncus is pleased to announce that on October 28, 2022, the Company's innovative product in the field of drug-device combination, "Mist FountainTM" (the "Product" or "Nebulizing Micro-Catheter"), a disposable nebulizing micro-catheter for endoscope,...

ABM Respiratory Care, a medical technology company focused on developing and globally commercializing novel integrated airway clearance and ventilation solutions, announced today it has received CE marking for their BiWaze® Cough system in accordance...

Pharming Group N.V. ("Pharming" or "the Company") (EURONEXT Amsterdam: PHARM / Nasdaq: PHAR) announces today that its Marketing Authorisation Application (MAA) for leniolisib has been validated for scientific evaluation under an accelerated...

Finerenone is the first non-steroidal, selective mineralocorticoid receptor (MR) antagonist to demonstrate positive kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes1The approval is based on...

The Perinatal Stem Cell Society has organized a workshop Nov. 3 in Fort Lauderdale, Fla. and streamed to unite the biologics industry and work with the FDA towards a patient-centered goal. "I called this one-day workshop so the industry can partner...

Accuray Incorporated announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved reimbursement for the CyberKnife® System for the treatment of trigeminal neuralgia (TN). The system provides an important new option for...

Single Pass, Inc. CEO, Bill Colone, announced treatment of the first patients in North America with the Kronos Electrocautery device designed to improve the safety of co-axial biopsy procedures. The single-use, disposable device uses battery current...

Medtronic plc , a global healthcare technology leader, has announced three significant global market-entrance and indication expansion approvals for its Hugotm robotic-assisted surgery (RAS) system. The approvals include: Conformité...

TAICEND TECHNOLOGY intends to target its marketing strategy primarily on the US medical market. We will participate in the MedTrade East International Medical Home Care and Rehabilitation Exhibition for the first time on October 24-26 this year. It...

SQI Diagnostics Inc. , a leader in the science of lung health that develops and manufactures respiratory health...

Akeso, Inc. (9926. HK) ("Akeso"), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, announced the Phase Ib/II clinical trial of its in-house...

Telix Pharmaceuticals Limited  today announces that the Chinese National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved an investigational new drug (IND) application to commence a pivotal Phase III registration...

Atara Biotherapeutics, Inc.  and Pierre Fabre today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion...

Telix Pharmaceuticals Limited  announces that Health Canada has approved Illuccix® [kit for the preparation of gallium (68Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumour...

According to International Diabetes Federation, approximately 537 million adults (20-79 years) are living with diabetes worldwide and 206 million adults of the Western Pacific region including China, Japan, and South Korea have diabetes in 2021....