News by subject: IMA

Ahead of World Digestive Health 2022, Italian pharmaceutical group Alfasigma is proud to announce the launch of its new...

SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, today announced CE (ConformitéEuropéenne) Mark approval for SeekInClarityTM Cancer Treatment Response Monitoring Kit and is now ready to launch this test in...

- Pfizer will provide all its current and future patent-protected medicines and vaccines available in the U.S. or EU on a not-for-profit basis to 45 lower-income countries. - Rwanda, Ghana, Malawi, Senegal and Uganda are the first five countries to...

Bausch + Lomb Corporation ("Bausch + Lomb"), a leading global eye health company dedicated to helping people see better to live better, today announced that Health Canada has approved LUMIFY® (brimonidine tartrate ophthalmic solution 0.025% w/v),...

Braxia Scientific Corp....

LumiraDx Limited , a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization...

CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that the World Health Organization ("WHO") has granted Emergency Use Listing ("EUL") for Convideciatm, CanSinoBIO's Recombinant Novel Coronavirus Vaccine (Adenovirus...

UL, a global safety science leader, today announced that Walgreens, an integrated healthcare pharmacy and retail leader, has earned a UL Verified Mark. This year, the UL Verified Mark will begin appearing on Walgreens brand vitamins and...

With this approval, Benuvia has begun focusing on four primary psychedelic ingredients: Psilocybin, N,N-Dimethyl-5-Methoxy-Tryptamine (5-MeO DMT), Dimethyltryptamine (DMT), and 3,4-Methylenedioxymethamphetamine, or MDMABenuvia will manufacture...

Faron Pharmaceuticals Ltd. ("Faron" or "Company") Faron Announces US Food and Drug Administration and Finnish Medicines Agency Approval to Initiate Phase I/II Bexmarilimab Combination Study in Hematologic Malignancies Phase 1 dose escalation study...

Antengene Corporation Limited ("Antengene" SEHK: 6996.HK), a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or...

Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), announced today that Health Canada has accepted the filing of a Supplement to a New Drug Submission (SNDS) for an investigational oral...

Yiling Pharmaceutical disclosed Wednesday that it had received the medicine approval document for Lianhua Qingwen Capsules from the National Agency for Food and Drug Administration and Control (NAFDAC), Nigeria. The Product Category is Herbal and...

Recently, The SARS-CoV-2 Antigen Nasal Test Kit(self-test) independently developed by Assure Tech (Hangzhou) Co., Ltd . (hereinafter referred to as " Assure Tech ") has obtained the EU CE certification. The product can be sold across EU countries and...

Vitti Labs, an AATB Accredited Tissue Bank focused on life Science Research, development, and manufacturing, announced today that the U.S. Food and Drug Administration (FDA) has approved their Investigational New Drug Application (IND) to move...

CNS Pharmaceuticals, Inc. ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has received approval...

Seeking to bolster its development of a biocompatible graft that promises to reshape the future of cardiac bypass surgery, Medical 21, a medtech device company, today announced it has filed a Form 1-A preliminary offering circular...

icometrix, the worldwide leader in digital health technology solutions for neurological conditions, announced the recent release of a Medtech Innovation Briefing (MIB) [MIB291] from the internationally renowned NICE for the CE markers and FDA cleared...

Otsuka Canada Pharmaceutical Inc. (OCPI) today announced that Health Canada has approved Tavneos® (avacopan), an orally administered selective complement 5a receptor...

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

AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody combination has received a Notice of Compliance from Health Canada for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (?12 years...

Juniper Biologics, a science-led healthcare company focused on researching, developing and commercializing novel therapies announced today that it has gained the licensing rights to develop and commercialize TG-C LD (TissueGene-C low dose) for the...

Apotex Corp. announced today its release of Paclitaxel protein-bound particles for injection (albumin-bound), a generic version of Abraxane® in the United States. Paclitaxel protein-bound particles for injectable suspension is indicated for the...

Telix Pharmaceuticals Limited  today announces its ProstACT TARGET Phase II clinical trial of the Company's prostate cancer antibody therapy candidate TLX591 (177Lu-DOTA-rosopatamab), in patients experiencing a first recurrence of prostate-specific...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of HANSIZHUANG (serplulimab), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with chemotherapy for the...

Merck, , known as MSD outside Canada and the United States, announced today that Health Canada has approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age for the prevention of infection caused by the Human...

The board of directors of Jiangsu Recbio Technology Co., Ltd. (the "Company", together with its subsidiaries, the "Group",Stock code:2179.HK) is pleased to announce that, on April 9, 2022, the Company has received the European Union (EU) Qualified...

Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the European Commission (EC) has expanded the marketing authorization for Dupixent® (dupilumab) in the European Union. Dupixent is...

Bened Biomedical announced recent approval of the company's probiotic L. plantarum PS128 in Thailand and Canada. Authorities in each country also endorsed health claims that may be made about the strain. Local distributors will launch PS128 products...

CNS Pharmaceuticals, Inc. ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers in the brain and central nervous system, today announced it has received approval...

Seegene Inc. (KQ 096530), South Korea's leading molecular diagnostics (MDx) company, today announced that its Allplextm RV Master Assay has received approval from Australia's Therapeutic Goods...

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

PDO Max, Inc., a leader in FDA cleared Polydioxanone (PDO) threads-in-cannula medical devices for non-surgical facial tissue repositioning, is proud to announce that their PDO device continues to comply with The Medical Device Single Audit Program ?...

The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that Health Canada has issued a Notice of Compliance with Conditions (NOC/c) approving RYBREVANT® (amivantamab), a fully-human, bispecific antibody, for the treatment of adult...

Akeso, Inc. (9926.HK) ( "Akeso" ), a China-based biopharmaceutical company focusing on the development and commercialization of innovative therapeutic antibodies for Oncology & Immunology, reported 2021 annual results. Highlights: Anniko®...

Novavax, Inc. , a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced submission of its request to expand the conditional marketing authorization (CMA) of...

JW Therapeutics (HKEx: 2126), an independent, innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, announced that it has received the Investigational New Drug (IND) clearance from the...

Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a comprehensive range of pharmaceutical products, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, has recently...

Seqirus, a global leader in influenza prevention, announced today that it has received Health Canada approval of FLUCELVAX® QUAD (Influenza Vaccine), its cell-based quadrivalent influenza vaccine for an expanded age indication for children as young...

Today sanofi-aventis Canada Inc. (Sanofi) announced the approval of Libtayo® (cemiplimab) for the treatment of adult patients with cervical cancer who have progressed on or after prior platinum-based chemotherapy and who require additional systemic...

Blueprint Medicines...

Shanghai Henlius Biotech, Inc. (2696.HK) announced that its first self-developed innovative PD-1 inhibitor HANSIZHUANG (generic name: serplulimab injection) has been approved by the National Medical Products Administration (NMPA) for the treatment of...

Vertex Pharmaceuticals (Canada) Incorporated today announced that Health Canada has granted Marketing Authorization for the expanded use of PrKALYDECO® (ivacaftor) in patients from 4 months to 18 years of age and weighing at least 5 kg with the...

Abbott today announced that the Japanese Ministry of Health,...

Innova Medical Group, Inc., a global health screening and diagnostic innovator and a world leader in the manufacture and distribution of...

First authorization of Novavax' COVID-19 vaccine in adolescent population receivedCovovaxtm (SARS-CoV-2 rS Protein (COVID-19) recombinant spike protein Nanoparticle Vaccine) is the first protein-based COVID-19 vaccine authorized for adolescents ?12...

CanSino Biologics Inc. ("CanSinoBIO") (SSE: 688185, HKEX: 06185) today announced that its Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) ("Ad5-nCoV", trade name: Convideciatm) has been approved by the Ministry of Health Malaysia...

TripSitter Clinic Ltd. ("TripSitter" or the...

Broncus(02216HK) today is pleased to announce that InterVapor® (including InterVapor Generator and InterVapor Catheter, the "InterVapor®"), the Company's thermal vapor treatment system, has been granted approval by the National Medical Products...

Calliditas Therapeutics AB ("Calliditas") today announced that partner Everest Medicines (HKEX 1952.HK) plans to submit an NDA for NEFECON in China in the second half of 2022. Everest received Breakthrough Therapy Designation (BTD) from the China...