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743,969 Results for "the medicines and healthcare products regulatory agency mhra".
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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
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4 min read
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
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2 min read
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Tristan Manalac
Biotech Beach
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 The Medicines and Healthcare products Regulatory Agency (MHRA) authorization of NULIBRY.
April 16, 2024
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6 min read
Biotech Beach
Cidara Therapeutics Announces Approval of REZZAYO by the MHRA for the Treatment of Invasive Candidiasis in Adults
Cidara Therapeutics, Inc. (Nasdaq: CDTX) today announced that the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) has approved REZZAYO (rezafungin acetate) for the treatment of invasive candidiasis in adults.
January 29, 2024
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5 min read
Emergex Announces MHRA Approval of MIA (IMP) Manufacturing and Import Authorisation License
Emergex Vaccines Holding Limited announced that Emergex has received its Manufacturing and Import Authorisation Investigational Medicinal Product from the UK’s Medicines and Healthcare Products Regulatory Agency to advance its novel T cell-priming vaccine candidates into clinical production.
June 18, 2024
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4 min read
Drug Development
GRI Bio Receives MHRA Authorization to Conduct Phase 2a Biomarker Study Evaluating GRI-0621 in the United Kingdom
GRI Bio, Inc. today announced the authorization of its Clinical Trial Application (CTA) by the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2a biomarker study evaluating GRI-0621 for the treatment of IPF in the UK.
March 4, 2024
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7 min read
BioCapital
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”) announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for DCVax®-L for glioblastoma brain cancer.
December 21, 2023
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7 min read
United Kingdom’s MHRA Approves YORVIPATH® (palopegteriparatide) in Great Britain for the Treatment of Adults with Chronic Hypoparathyroidism
Ascendis Pharma A/S announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency has granted marketing authorization for YORVIPATH® in Great Britain as a parathyroid hormone replacement therapy indicated for the treatment of adults with chronic hypoparathyroidism, and has also granted YORVIPATH orphan drug status.
April 24, 2024
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5 min read
Drug Development
Precision BioSciences Announces MHRA Approval for Partner iECURE to Expand Phase 1/2 Clinical Trial of ARCUS Gene Editing Program in OTC Deficiency
Precision BioSciences, Inc. today announced that its partner iECURE has received approval from the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) for the company’s Clinical Trial Authorization (CTA) application to expand the Phase 1/2 OTC-HOPE study evaluating ECUR-506 into the U.K.
March 6, 2024
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10 min read
Biotech Beach
Mirati Therapeutics Receives Approval from the MHRA for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation
Mirati Therapeutics, Inc. (NASDAQ: MRTX), a commercial stage biotechnology company, today announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) granted conditional marketing authorization approval for KRAZATI®.
November 3, 2023
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6 min read
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