News by subject: IMA

Calliditas Therapeutics AB (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the...

Calliditas Therapeutics AB (STO: CALTX) ("Calliditas") today announced that its partner STADA Arzneimittel AG ("STADA") has submitted a request to the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom to convert the...

The updated vaccine (XBB.1.5 variant-adapted monovalent COVID-19 vaccine) is now authorized in Canada for individuals 6 months of age and olderThe updated vaccine is administered as a single dose for individuals 5 years of age and older, regardless...

Apex Labs Ltd. (APEX or the Company), a pharmaceutical company transforming the standard of mental health care with psilocybin treatments is excited to announce that a physician has been authorized to receive APEX-90 macrodose psilocybin drug product...

BioArctic AB's (publ) partner Eisai announced today that "LEQEMBI® Intravenous Infusion" (200 mg, 500mg, lecanemab) has been approved in Japan as a treatment for slowing progression of mild cognitive impairment (MCI) and mild dementia due to...

Jazz Pharmaceuticals plc today announced that the European Commission (EC) has granted marketing authorization for Enrylaze® (JZP458; a recombinant Erwinia asparaginase or crisantaspase) for use as a component of a multi-agent chemotherapeutic...

Body Vision Medical, a leader in AI-driven intraoperative imaging announced today that its latest generation LungVisiontm AI-powered lung navigation and real-time imaging platform has been granted certification as a Class IIa medical device under the...

CELL Technologies Inc. is pleased to announce the award of a No Objection Letter (NOL) from Health Canada to launch the first ever pivotal stem cell program in pain and Osteoarthritis in the world....

Field Medical, Inc. (Field Medical), an emerging leader in cardiac catheter ablation, announced today that it has closed its oversubscribed seed round with investments totaling $14M.  The convertible note funding was led by private investors who...

Gedeon Richter Plc. ('Richter') together with Sumitomo Pharma America, Inc. ('SMPA') and Sumitomo Pharma Switzerland GmbH ('SMPS') today announce that the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency...

AIRS Medical Inc., an AI-powered healthcare solution provider headquartered in Korea announces the attainment of MDSAP (Medical Device Single Audit Program) certification. This milestone achievement underscores AIRS Medical's commitment to quality...

Moderna Biopharma Canada Corp. today announced Health Canada has authorized its updated COVID-19 vaccine, SPIKEVAX® XBB.1.5, to prevent COVID-19 in individuals 6 months of age and older.i  Now approved for use, Moderna's updated COVID-19 vaccine will...

TMRW Life Sciences, a fertility technology company automating the IVF lab, today announced that it has received a CE Mark for the CryoRobot Select (CRS). The European designation follows clearance by the U.S. Food and Drug Administration, and the two...

Insightec, a global healthcare company specialising in MR-guided focused ultrasound (MRgFUS), today announced it has received additional CE mark approval for treatment...

Genesis MedTech, a leading medical device company, today announced that its absorbable sutures with antibacterial protection have successfully obtained approval from the China's National Medical Products Administration (NMPA) for market release. The...

Guangzhou Gloria Biosciences ("GloriaBio"), a...

Alteogen Inc. (KOSDAQ:196170), a Korean biotech company announced that their recently concluded...

Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced that its subsidiary, Nanjing Changcheng Medical Equipment Co., Ltd.,...

Zylox-Tonbridge Medical Technology Co., Ltd. (2190.HK, hereinafter referred to as "Zylox-Tonbridge" or the "Company") announced that its ZENFlow Tigertm LD PTA Dilatation Catheter (hereinafter referred to as "ZENFlow Tigertm"), a product...

Cellmyx Inc., a pioneering medical technologies company known for its commitment to advancing cosmetic surgery and regenerative medicine, is excited to announce the Health Canada Medical Device License (MDL) clearance for its groundbreaking...

Submissions are supported by two Phase 3 clinical trials demonstrating risankizumab achieved the primary endpoint of clinical remission (per Adapted Mayo Score) and key secondary endpoints as an induction and maintenance treatment1,2Safety results...

Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, announced today that the National Center for Drug...

Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today that the Pharmaceutical Administration...

Kvikna Medical, the international electroencephalogram (EEG) software and hardware division of Stratus, today announced it has received European Medical Device Regulation certification from its certified body the British Standards Institution (BSI)....

Dizal today announced that sunvozertinib has been approved by the National Medical Products Administration (NMPA) of China for the treatment of...

CanariaBio Inc., a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative immunotherapies for cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the European Medicines Agency (EMA) has accepted for regulatory review the marketing authorization application (MAA) for avacincaptad pegol (ACP), an...

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 Government of Hong Kong...

Baird Medical Investment Holdings Limited ("Baird Medical" or the "Company"), a leading microwave ablation ("MWA") medical device developer and provider in China, today announced the 510(k) premarket notification submission of the Company's...

Nevro Corp. has announced today the launch of HFX Connect in Europe and CE marking of expanded labelling (Painful Diabetic Neuropathy, PDN and Non-Surgical Back Pain, NSBP) for the HFX SCS system. The latest development from the global medical...

China Pharma Holdings, Inc. ("China Pharma," the "Company" or "We"), a specialty pharmaceutical company, today announced that its wholly-owned subsidiary Hainan Helpson Medical & Biotechnology Co., Ltd. (hereinafter referred to as "Helpson") has...

Mitsubishi Tanabe Pharma Canada (MTP-CA), a subsidiary of Mitsubishi Tanabe Pharma America, Inc. (MTPA), today announced that RADICAVA® Oral Suspension (edaravone) is now covered under the Ontario Drug Benefit Formulary (Exceptional Access Program)...

RedHill's partner, Gaelan Medical, part of the Ghassan Aboud Group (GAG), receives marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia Gaelen placed a meaningful initial Talicia order and commences commercialization...

Zhejiang Doer Biologics Co., Ltd. ("Doer Bio"), a clinical stage biopharmaceutical company developing innovative biotherapeutics for metabolic diseases and cancers, today announces that DR10624, its first-in-class (FIC), tri-specific agonist...

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA)...

Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") announced today that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human...

In the face of ever-changing circumstances, technological innovation remains the eternal driving force behind the long-term growth of biopharmaceutical companies. It continuously breathes life into these enterprises, enabling them to successfully...

Approval is based on results from three Phase 3 studies: two for induction and one for maintenance 1,2,3In clinical trials, patients taking RINVOQ achieved the primary endpoint of clinical remission (per modified Mayo Score [mMS]) at weeks 8 and 52...

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...