Search Results

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.

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.

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.

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.

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.

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.

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.

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.