Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company focused on developing life-saving therapies, announced a significant breakthrough with the United Kingdom (U.K.) Medicines and Healthcare products Regulatory Agency (MHRA) approving REZZAYO (rezafungin acetate) for invasive candidiasis treatment in adults. This announcement is a major advancement in healthcare, addressing a critical need for new treatments in […]
Mirati Therapeutics, Inc. (NASDAQ: MRTX), an innovative biotechnology company, has received conditional authorization from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for its KRAZATI (adagrasib) monotherapy. This approval marks a pivotal milestone for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) who present the KRASG12C mutation and have not […]
Alkem Laboratories Limited (Alkem Labs) revealed that it has cleared an online inspection held by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of its bioequivalence center in Taloja, Maharashtra. According to the Indian pharma company, the inspection of the bioequivalence facility in Taloja was carried out from 31 January 2022 and 4 February […]
AstraZeneca said that its antibody combination Evusheld (tixagevimab co-packaged with cilgavimab) has been authorized by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the prevention of Covid-19 in Britain. Evusheld has been approved to be used in adults who are not presently infected with (or know exposure to) the Covid-19 virus and are […]
Marksans Pharma Limited said that its fully-owned subsidiary Relonchem Limited has secured market authorization from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for Loperamide 2mg hard capsules. The Indian pharma company will manufacture the Loperamide 2mg hard capsules at its oral dosage facility in Goa. The facility has the approval of the UK […]
FDC Limited said that it has secured Good Manufacturing Practice (GMP) certificate for its ophthalmic facility in Aurangabad, Maharashtra from the UK Medicines and Healthcare Products Regulatory Agency (UK MHRA). The Indian pharma company said that the GMP certificate continues with its approved status from the UK agency for the ophthalmic facility in Waluj. The […]
Indoco Remedies said that it has secured GCP and GLP accreditation from the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for AnaCipher, the company’s clinical research organization in Hyderabad. The accreditation was given following a virtual inspection undertaken from 4th – 7th May and 10th – 11th May, 2021. The inspection covered all the […]
The UK has given a temporary authorization for emergency use for the BNT162b2 Covid-19 vaccine candidate developed by Pfizer and BioNTech. The emergency use authorization (EUA) from the UK Medicines & Healthcare Products Regulatory Agency (MHRA) for the mRNA vaccine candidate follows the release of positive results of a global phase 3 trial. Pfizer and […]
