International Medical Approval

The latest news regarding applications for approval and other processes from medical regulatory bodies around the world. This section contains releases relating to consideration of new products, drugs, therapies and treatments.

Latest

14 Nov, 2024, 17:01 GMT CHMP issues positive recommendation for approval of lecanemab in the EU

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive ...

12 Nov, 2024, 12:00 GMT Nevro's HFX iQ™ Spinal Cord Stimulation with AI Technology Receives CE Mark Certification in Europe, Increasing Product Expansion Globally

Nevro Corp. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic...

31 Oct, 2024, 07:03 GMT CStone Announces MHRA Approval of Sugemalimab for First-Line Treatment of Non-Small Cell Lung Cancer (NSCLC) in the UK

CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, ...

19 Oct, 2024, 05:00 GMT Accord Healthcare receives positive CHMP opinion for IMULDOSA®, a ustekinumab biosimilar to Stelara®

Accord Healthcare Limited (Accord) a subsidiary of Intas Pharmaceuticals, announces that the Committee for Medicinal Products for Human Use (CHMP) of ...

02 Oct, 2024, 08:23 GMT SyntheticMR Receives Regulatory Approval for SyMRI 15 in Switzerland

SyntheticMR AB, global leader in advanced quantitative imaging software, is pleased to announce that its SyMRI 15 solution has received regulatory...

01 Oct, 2024, 09:00 GMT Relu Secures FDA 510(k) and CE Marking for Revolutionary Dental Software Relu® Creator

Relu, a pioneer in artificial intelligence (AI) assisted segmentation for dental labs and software companies, proudly announces the dual achievement...

21 Sep, 2024, 06:00 GMT Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult patients with Extensive-Stage Small Cell Lung Cancer

Intas Pharmaceuticals Limited ("Intas") has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ...

12 Sep, 2024, 16:19 GMT Stapokibart Was Granted Marketing Approval From National Medical Products Administration For The Treatment Of Moderate-to-severe Atopic Dermatitis in Adults

Keymed Biosciences Inc. (HKEX: 02162) today announced the National Medical Products Administration (the "NMPA") of China has recently approved the...

29 Aug, 2024, 07:41 GMT Augere Medical Secures MDR CE-mark for its PolypAId™ Software and System

After more than 10 years of basic research, product and clinical development, the Medical Device Regulation (MDR) CE-mark is a crucial milestone and...

28 Aug, 2024, 07:00 GMT Vitestro Achieves CE Marking for Autonomous Blood Drawing Device

Vitestro, a pioneer in the field of medical robotics, is proud to announce that its innovative automated blood drawing device has received CE marking....

26 Aug, 2024, 07:00 GMT SIFI Receives European Commission Approval for AKANTIOR®

SIFI, a leading international ophthalmic company, today announced the European Commission has approved AKANTIOR® (polihexanide) for the treatment of...

16 Aug, 2024, 10:00 GMT De Motu Cordis (DMC) Applauds ARS Pharma's FDA Approval of Neffy®, Expanding Patient Options to Needle-Free Epinephrine Delivery and Inspiring Confidence in Our Own Development Efforts

De Motu Cordis (DMC) is pleased to acknowledge and enthusiastically commends the recent U.S. FDA approval of ARS Pharma's Neffy®, the first-ever...

14 Aug, 2024, 07:00 GMT SOPHiA DDM™ Platform Certified Under IVDR

SOPHiA GENETICS (Nasdaq: SOPH), a cloud-native healthcare technology company and a global leader in data-driven medicine, today announced that its...

08 Aug, 2024, 03:19 GMT WestGene to Advance Clinical Trials Following Dual IND Approvals for World's First EB Virus-Related mRNA Therapeutic Cancer Vaccine

WestGene Biopharma is proud to announce that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China's National...

01 Aug, 2024, 00:00 GMT Prestige Biopharma's Herceptin Biosimilar Tuznue® Receives Positive CHMP Opinion from the EMA

Prestige Biopharma, a pioneer in biopharmaceuticals, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European...

31 Jul, 2024, 10:33 GMT Kexing Biopharm's Albumin-bound Paclitaxel Granted EU Market Approval

On July 28 2024, Kexing Biopharm announced European Commission approval of Apexelsin®, the generic drug to Bristol Myers Squibb's and Celgene's...

26 Jul, 2024, 12:27 GMT CStone Announces European Commission Approval of Sugemalimab (Cejemly®) as First-Line Treatment for Non-Small Cell Lung Cancer

CStone Pharmaceuticals ("CStone", HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer...

25 Jul, 2024, 08:00 GMT SIBIONICS Secures MoHAP Product Marketing Authorization Approval for Its GS1 CGM in UAE

SIBIONICS, a leading innovator in continuous glucose monitoring technology, announced today that it has received Product Marketing Authorization...

12 Jul, 2024, 03:09 GMT Leqembi approved for the treatment of Alzheimer's disease in Israel

BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that Leqembi® (generic name: lecanemab) has been approved for...

11 Jul, 2024, 02:55 GMT Leqembi approved for the treatment of Alzheimer's disease in Hong Kong

BioArctic AB's (publ) (NASDAQ Stockholm: BIOA B) partner Eisai announced today that the Department of Health in Hong Kong has approved Leqembi®...
Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA™ (vibegron) in overactive bladder.

28 Jun, 2024, 15:42 GMT Pierre Fabre Laboratories announce granting of European marketing authorization for OBGEMSA™ (vibegron) in overactive bladder.

The European Commission (EC) has authorized the marketing of OBGEMSA™ (vibegron) by Pierre Fabre Laboratories for the symptomatic treatment of...

27 Jun, 2024, 19:46 GMT Inside Information: Update for Bioretec's RemeOs™ Trauma Screw European Marketing Authorization

Bioretec Ltd., a pioneer in bioresorbable orthopedic implants, announces that according to the information received from the Notified Body (Dekra),...

24 Jun, 2024, 15:58 GMT EMA Approves Biocon Biologics' New mAbs Facility in India and Renews GMP Certifications for India and Malaysia Sites

Biocon Biologics Ltd (BBL), a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), has...

01 Jun, 2024, 15:51 GMT CStone Announces European Medicine Agency CHMP Recommends Approval of Cejemly® (sugemalimab, anti-PD-L1) as First-Line Treatment for NSCLC

CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, ...

30 May, 2024, 18:20 GMT Calliditas partner STADA receives positive CHMP opinion recommending full approval for Kinpeygo® for the treatment of IgA nephropathy

Calliditas Therapeutics AB (Nasdaq: CALT) (Nasdaq Stockholm: CALTX) ("Calliditas"), today announced that the Committee for Medicinal Products for...

Journalists and Bloggers

The news you need, when you need it.

Join PR Newswire for Journalists to access all of the free services designated to make your job easier.

In need of subject matter experts for your story? Submit a free ProfNet request and find the sources you need.

LEARN MORE