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

16 Apr, 2024, 12:30 GMT Sentynl Therapeutics Receives MHRA Authorization of NULIBRY® (fosdenopterin) for Treatment of MoCD Type A in Great Britain

Sentynl Therapeutics, Inc. (Sentynl), a U.S.-based biopharmaceutical company wholly-owned by Zydus Lifesciences, Ltd. (Zydus Group), today announced...

15 Apr, 2024, 14:21 GMT Norgine B.V. submits Marketing Authorisation Application via Project Orbis for eflornithine (difluoromethylornithine [DFMO]) in high-risk neuroblastoma

Norgine B.V. today announced its first marketing authorisation application submissions on 10 April 2024, seeking approval for eflornithine in...

28 Mar, 2024, 10:00 GMT Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, has received marketing authorization in the Netherlands (RVG 130527)

Isotopia Molecular Imaging Ltd. is thrilled to announce that Isoprotrace®, our PSMA -11 kit, has received marketing authorization in the Netherlands...

26 Mar, 2024, 15:54 GMT Norgine receives positive CHMP opinion recommending approval of NPJ5008 (dantrolene sodium hemiheptahydrate) for the treatment of malignant hyperthermia

Norgine B.V. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a...

13 Mar, 2024, 08:30 GMT Biocomposites announces approval of STIMULAN in Brazil as an antibiotic carrier for treating bacterial infection

Biocomposites, an international medical devices company that engineers, manufactures and markets world leading products for use in infection...

05 Mar, 2024, 12:17 GMT Sanofi responds to NICE negative FAD of olipudase alfa

Rippon Ubhi, Country Lead, Sanofi UK and Ireland, said: "We are extremely disappointed and saddened by the decision by the National Institute for...

04 Mar, 2024, 08:00 GMT Insightec's Groundbreaking Transcranial MR-Guided Focused Ultrasound (MRgFUS) Approved for Additional Reimbursement for Essential Tremor in Germany

Insightec, a pioneer and global leader in focused ultrasound, is pleased to announce that its transcranial MR-guided focused ultrasound (MRgFUS) has...
Biosense Webster Announces CE Mark approval in Europe for VARIPULSE™ Pulsed Field Ablation (PFA) Platform

29 Feb, 2024, 09:00 GMT Biosense Webster Announces CE Mark approval in Europe for VARIPULSE™ Pulsed Field Ablation (PFA) Platform

Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech, today announced European CE mark...

05 Feb, 2024, 13:00 GMT Fermion's TYK2 JH2 Inhibitor FZ007-119 Granted IND Approval by China NMPA

Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for...

29 Jan, 2024, 17:17 GMT INSIGHTEC MR-GUIDED FOCUSED ULTRASOUND TECHNOLOGY RECOMMENDED FOR NATIONAL COVERAGE FOR DUTCH PATIENTS LIVING WITH ESSENTIAL TREMOR

Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute...

29 Jan, 2024, 09:00 GMT Daewoong Pharmaceutical's Bersiporocin Receives 'Orphan Drug Designation' in Europe to Treat Idiopathic Pulmonary Fibrosis

Daewoong Pharmaceutical's Bersiporocin (DWN12088) has been recognized as a significant advancement in treating idiopathic pulmonary fibrosis (IPF), a ...

11 Jan, 2024, 08:00 GMT AIRS Medical Receives EU Medical Device Regulation CE Certification for SwiftMR™

AIRS Medical, a leading AI-powered healthcare solution provider, is thrilled to announce that it has received EU Medical Device Regulation (MDR) CE...
Pulsenmore Receives Brazilian ANVISA Approval for Its Prenatal Home Ultrasound Solution

10 Jan, 2024, 09:00 GMT Pulsenmore Receives Brazilian ANVISA Approval for Its Prenatal Home Ultrasound Solution

Pulsenmore (TASE: PULS), the global leader in self-scan ultrasound technology for home use, proudly announces the approval of its pioneering prenatal ...

10 Jan, 2024, 07:11 GMT Fermion announces IND Approval of Non-Addictive Pain Relief Drug FZ008-145 by China NMPA

Guangzhou Fermion Technology Co., Ltd. (Fermion), a clinical-stage AI-based drug discovery company that specializes in developing drugs for...

21 Dec, 2023, 14:30 GMT Northwest Biotherapeutics Announces That A Marketing Authorization Application Has Been Submitted To The UK MHRA For DCVax®-L For Glioblastoma

Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers,...

11 Dec, 2023, 17:41 GMT The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of...

11 Dec, 2023, 16:45 GMT Guerbet announces marketing authorisation approval of Elucirem™ (Gadopiclenol) in the European Union

Guerbet, global leader in contrast products for medical imaging, announced today that the European Commission has approved the marketing in the...

05 Dec, 2023, 08:30 GMT Mission Therapeutics granted MHRA Clinical Trial Authorisation (CTA) for MTX325 for the treatment of Parkinson's Disease

Mission Therapeutics ("Mission" or the "Company"), a clinical-stage biotech developing first-in-class therapeutics targeting mitophagy, today...

23 Nov, 2023, 03:48 GMT EirGenix's Breast Cancer Biosimilar Receives Marketing Authorization by EC

EirGenix Inc. (6589. TT) announced today that its trastuzumab biosimilar medicine (EG12014) which their commercial partner Sandoz plans to...

21 Nov, 2023, 19:22 GMT Huma obtains multi-condition Saudi FDA Class C regulatory certification for its configurable SaMD disease management platform

Huma Therapeutics ("Huma"), a leading global digital health firm, announced today that it has received Saudi FDA Class C certification for a...

17 Nov, 2023, 15:19 GMT The European Commission Approves Label Update for TAKHZYRO® (lanadelumab), Expanding Its Use to a Broader Group of Paediatric Patients with Recurrent Attacks of Hereditary Angioedema (HAE)

Takeda (TSE:4502/NYSE:TAK) today announced the European Commission has approved TAKHZYRO® (lanadelumab) for the routine prevention of recurrent...

31 Oct, 2023, 22:00 GMT Syqe Medical's Revolutionary SyqeAir Inhaler Obtains ARTG Approval in Australia, Marking a Historic Milestone in the Field of Medicinal Cannabis Treatment

Syqe Medical, a global leader in innovative medical inhalation technology, together with Australian sponsor and distribution partner Novachem, is...

31 Oct, 2023, 20:48 GMT Novavax's Updated COVID-19 Vaccine Now Approved in the EU

Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the European Commission...

26 Oct, 2023, 08:00 GMT UZ Brussel PERT and Aidoc Pave the Way as First Hospital in Europe for Expedited Treatment of Pulmonary Embolism with AI

Aidoc today announced a pioneering collaboration with the Pulmonary Embolism Response Team (PERT) at UZ Brussel (UZB), becoming the first European...

24 Oct, 2023, 06:00 GMT The dental and medicinal benefits board, TLV, has decided on 19 October that ORGOVYX® (relugolix), tablets for the treatment of advanced hormone-sensitive prostate cancer in Sweden, should be included in the pharmaceutical benefit scheme from 2023-10-20

Accord Healthcare (Accord), is pleased to announce that patients with advanced prostate cancer now have access to a new treatment option when TLV has ...

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