News by subject: IMA

AvenCell Therapeutics, Inc., a leading clinical-stage cell therapy company focused on advancing both switchable and allogeneic engineered CAR-T cell therapies, today announced that the European Medicines Agency (EMA) has approved the company's...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of 7MW3711 for advanced malignant solid tumor was approved by the National Medical Products Administration (NMPA)....

PTC Therapeutics, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the extension of the Evrysdi® (risdiplam) marketing authorization to include infants under two months of age in...

GC Biopharma, a South Korean biopharmaceutical company, announced on the 18th that its quadrivalent flu vaccine called GC FLU Quadrivalent Pre-filled syringe inj. has been approved by the Egyptian...

STORZ & BICKEL GmbH ("STORZ & BICKEL"), the world-leading manufacturer of high-end and medically certified cannabis vaporizers and subsidiary of Canopy Growth Corporation , today announced the certification of its premium VOLCANO MEDIC 2 and the...

The product of Fosun Kite Biotechnology Co., Ltd., jointly established by Shanghai Fosun Pharmaceutical (Group) Co., Ltd. and Kite Pharma of the United States (trade name: Yikaida®) for the treatment of adult large B-cell lymphoma (r/r LBCL) ("this...

Daewoong Pharmaceutical obtained approval for a SGLT-2 inhibitor+metformin combination drug in just one month after the release of Envlo Tab., the 1st SGLT-2 inhibitor by Korea, expanding its product portfolio. Daewoong Pharmaceutical (Jeon Sengho...

Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, announced that its clinical trial application of 9MW2921 for advanced solid tumor was approved by the National Medical Products Administration (NMPA). 9MW2921 is...

ReddyPort announced today that the US Food and Drug Administration (FDA) granted 510(k) premarket clearance for the ReddyPort elbow device used in non-invasive ventilation (NIV)....

Antengene Corporation...

Emmaus Life Sciences, Inc. , a leader in sickle cell disease treatment, today announced that it has received marketing authorization from the Oman Ministry of Health for the commercial distribution and sale of Endari® (L-glutamine oral powder) in the...

Global pharma major Lupin Limited (Lupin) announced on May 26, 2023, that its Canada subsidiary, Lupin Pharma Canada Ltd., has received approval from Health Canada to market a generic version of Spiriva® (tiotropium bromide inhalation powder) for the...

Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, announces that it has...

Genesis MedTech, a leading medical device company, today announced that its ArtiSentialtm, a revolutionary series of articulating laparoscopic instruments, has successfully obtained approval from the China's National Medical Products Administration...

Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its novel KRAS G12C inhibitor glecirasib's pivotal study for pancreatic cancer has been approved from CDE (Center for Drug Evaluation),...

RareStone Group, a rare disease-focused company aiming to establish the first rare disease ecosystem in China, announced that on June 30, the Chinese National Medical Products Administration (NMPA)  approved pitolisant (Wakix) for the treatment of...

Endo International plc announced today that Paladin Labs Inc., an Endo operating company, received Health Canada's approval of XCOPRItm (cenobamate tablets) for adjunctive therapy in the management of partial-onset seizures in adults with epilepsy...

Sihuan Pharmaceutical Holdings Group Ltd together with its subsidiaries, is pleased to announce that Xuanzhu Biopharmaceutical Co., Ltd. ("Xuanzhu Biopharm"), a non-wholly owned subsidiary of Company, has received a drug registration approval from...

Independent biopharmaceutical company Specialised Therapeutics (ST) is pleased to announce that a new therapy to treat the most common type of non-Hodgkin lymphoma in adults ? diffuse large B-cell lymphoma ? is now approved for use in...

Aurisco Pharmaceutical has good reasons to celebrate. On its 25th anniversary, the high-tech pharmaceutical company dedicated to innovation has received its first Marketing Authorization Approval in China for AUXITON®, the oral finished dosage form...

Aurisco Pharmaceutical has good reasons to celebrate. On its 25th anniversary, the high-tech pharmaceutical company dedicated to innovation has received its first Marketing Authorization Approval in China for AUXITON®, the oral finished dosage form...

LASEROPTEK Co., Ltd., a developer and manufacturer of world-class lasers for medical aesthetic and dermatology indications, is pleased to announce that Dr. Neil Shah, MD, FAAD, founder and medical director of Clarus Dermatology, a...

Akebia Therapeutics®, Inc. today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the...

Sirnaomics Ltd. (the "Company"; stock code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company in discovery and development of RNAi therapeutics, today announced the advancement of STP705 for the...

Thorne HealthTech, Inc. ("Thorne") , a leader in delivering innovative solutions for a personalized approach to health and wellness, announced today that its NanoDrop device has received a CE (Conformite Europeenne) Mark certification and has...

Gencurix, a leading cancer molecular diagnostics company, has obtained approval from the Korean Ministry of Food and Drug Safety for its Droplex EGFR Mutation Test v2. This product is a companion diagnostic test designed to detect EGFR mutations...

On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities...

On June 8th, 2023, Coviccine® Trivalent XBB.1.5-Recombinant COVID-19 Trivalent (XBB.1.5+BA.5+Delta) Protein Vaccine (Sf9 cell) developed by WestVac Biopharma/ West China Medical Center, Sichuan University was approved for EUA by relevant authorities...

BioArctic AB's (publ) partner Eisai announced today that Eisai has submitted a marketing authorization application for lecanemab (brand name in the U.S.: LEQEMBItm), an investigational anti-amyloid beta (A?) protofibril[1] antibody, for the...

IFF today announced its HOWARU® probiotic strain Lacticaseibacillus rhamnosus HN001® has won the NIS Golden Açaí Awards' Applied Ingredients category. The award, presented at a ceremony in São Paulo, is given in recognition of IFF's HOWARU® HN001®...

Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and...

TWi Biotechnology (TWiB), a clinical stage biopharmaceutical company specializing in development of repositioned drugs for unmet medical needs, is currently seeking participants for a Phase 1 clinical trial of a topical gel called tofacitinib for the...

Trajan Scientific and Medical, a leading provider of analytical and life sciences products and solutions, today announced the regulatory approval of its Neoteryx remote blood microsampling devices, Mitra® and hemaPEN® for clinical use in Europe and...

Akeso Inc. (9926. HK, "Akeso") announced today that China's National Medical Products Administration (NMPA) has accepted its New Drug Application (NDA) for its fully human anti-PCSK9 monoclonal antibody ebronucimab (AK102) for 2 indications 1)...

Emmaus Life Sciences, Inc. , a leader in sickle cell disease treatment, announced today that it has received a Medicine Registration Certificate (DRN-10164/23) from the Bahrain National Health Regulatory Authority (NHRA) granting marketing...

Cepheid announced today that it has received the CE mark for Xpert NPM1 Mutation, a molecular in vitro diagnostic test for the quantification of mutant NPM1 mRNA transcripts (types A, B and D in exon 12) in peripheral blood specimens from patients...

SK bioscience, a global innovative vaccine and biotech company committed to...

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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 Commission (EC) has granted orphan...

Following the exclusive licensing agreement with Urovant Sciences GmbH, Pierre Fabre announced today the start of the EU marketing authorization application procedure (centralized procedure) for Vibegron, a novel, potent, and selective human ?3...

Soligenix, Inc. (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, announced today that the European Patent Office has...

"Today we are pleased to announce that Invivoscribe's LeukoStrat® CDx FLT3 Mutation Assay has been approved by BSI (Netherlands) and the EMA as a Class C CDx assay, meeting the stringent new IVDR (Regulation (EU) 2017/746) requirements. Invivoscribe...

Nippon Express Italia S.p.A. (hereinafter "NX Italia"), a group company of NIPPON EXPRESS HOLDINGS, INC., has acquired IATA CEIV Pharma certification*, a quality certificate for pharmaceutical transport established by the International Air Transport...

Nippon Express Italia S.p.A. (hereinafter "NX Italia"), a group company of NIPPON EXPRESS HOLDINGS, INC., has acquired IATA CEIV Pharma certification*, a quality certificate for pharmaceutical transport established by the International Air Transport...

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, autoimmune, metabolic, ophthalmology and other major...

Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") announces today that the China...

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 AB011 in combination with atezolizumab monoclonal...

Chiesi Global Rare Diseases, a business unit of the Chiesi Group established to deliver innovative therapies and solutions for people affected by rare diseases, and Protalix BioTherapeutics, Inc. , a biopharmaceutical company focused on the...

sanofi-aventis Canada Inc. (Sanofi Canada) is pleased to announce that Health Canada has issued a Notice of Compliance for DUPIXENT® (dupilumab injection) for the treatment of patients aged 12 years and older, weighing at least 40 kg, with...

Bausch Health Companies Inc. is pleased to announce the availability across Canada of its new prescription treatment RYALTRIS® (olopatadine hydrochloride and mometasone furoate nasal spray). RYALTRIS has been approved by Health Canada for the...