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665,843 Results for "medicines and healthcare products regulatory agency".
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Press Releases
Moderna Receives Medicines And Healthcare Products Regulatory Agency (MHRA) Authorization For Updated COVID-19 Vaccine Targeting SARS-COV-2 Variant JN.1
September 3, 2024
·
4 min read
Press Releases
Alnylam Submits Regulatory Application to the European Medicines Agency for Vutrisiran for the Treatment of ATTR Amyloidosis with Cardiomyopathy
October 17, 2024
·
8 min read
Drug Development
PepGen Announces Clearance of CTA by UK Medicines & Healthcare Products Regulatory Agency to Begin CONNECT2-EDO51, a Phase 2 Clinical Trial designed to support potential accelerated approval of PGN-EDO51 for the Treatment of DMD
PepGen Inc. announced that the UK Medicines & Healthcare products Regulatory Agency has authorized its Clinical Trial Application to initiate the CONNECT2-EDO51 Phase 2 clinical trial of PGN-EDO51 in patients with Duchenne muscular dystrophy amenable to an exon 51-skipping approach.
March 4, 2024
·
7 min read
Press Releases
Ocugen Announces European Medicines Agency Grants Orphan Medicinal Product Designation for Modifier Gene Therapy Candidate OCU410ST for Treatment of ABCA4-Associated Retinopathies including Stargardt Disease
November 20, 2024
·
5 min read
Policy
Nexalin Technology Announces Regulatory Approval to Sell Nexalin’s Gen-2, 15 mA Neurostimulation Device by the Brazilian Health Regulatory Agency (Anvisa)
Nexalin Technology, Inc. announced that its second generation, 15 milliamp neurostimulation device has been granted regulatory approval by the Brazilian Health Regulatory Agency, a regulatory body of the Brazilian government responsible for approving new drugs and medical devices.
June 13, 2024
·
3 min read
Press Releases
Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency
November 20, 2024
·
6 min read
Johnson & Johnson submits regulatory applications to European Medicines Agency for TREMFYA® (guselkumab) for treatment of patients with ulcerative colitis and Crohn’s disease
Janssen-Cilag International NV, a Johnson & Johnson company, today announced it has submitted applications to the European Medicines Agency to include the treatment of adult patients with moderately to severely active ulcerative colitis and moderately to severely active Crohn’s disease.
May 1, 2024
·
14 min read
Regulatory
EU Regulatory Panel Recommends Against Approval of Eisai, Biogen’s Leqembi for Alzheimer’s
The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment.
July 26, 2024
·
2 min read
·
Tyler Patchen
GLP-1
UK’s MHRA Finds No Risk of Suicidal Ideation, Self-Harm With GLP-1 Drugs
Like its U.S. and European counterparts, Britain’s Medicines and Healthcare Products Regulatory Agency found no conclusive link between the use of GLP-1s and a heightened risk of suicidal and self-injury thoughts.
September 5, 2024
·
2 min read
·
Tristan Manalac
Pharm Country
Lisata Therapeutics Receives Paediatric Investigation Plan Waiver from the European Medicines Agency for Certepetide in Pancreatic Cancer
Lisata Therapeutics, Inc. today announced that it has reached agreement with the European Medicines Agency (the “EMA”) on a Paediatric Investigation Plan (“PIP”) for Lisata’s lead investigational product, certepetide (formerly LSTA1), in pancreatic cancer.
May 20, 2024
·
7 min read
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