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The Medicines and Healthcare products Regulatory Agency (MHRA) has today (11 March 2024) approved the medicine quizartinib (Vanflyta) to be used alongside chemotherapy as first line treatment for adults who have acute myeloid leukaemia (AML).
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
The MHRA has approved the combined antibiotic cefepime/enmetazobactam (Exblifep 2 g/0.5 g powder for concentrate for solution for infusion)
The New Active Substance Work Sharing Initiative (NASWSI) has successfully approved several medicines through this international collaboration and continues to foster cooperation and strong relationships between its Access partners. The Biosimilar Work Sharing Initiative (BSWSI) builds on this success.
The MHRA has authorised cabotegravir as 30 mg tablets and as a 600 mg long-acting injection administered every two months
Past and current clinical trials into therapeutic and antiviral treatments for COVID-19, how to take part, and which treatments have proven to be effective.
Details of certificates issued under the Special Import System for the top ten veterinary medicines that were imported 1 Oct - 31 Dec 2023.
Bristol-Myers Squibb Pharmaceuticals Limited has informed the MHRA that a potential product quality issue has been detected, relating to incomplete crimping of the metal crimp cap of OPDIVO 10mg/mL concentrate for solution for infusion (nivolumab) (1VLX10ML).
Product Safety Report for PTS Packers and Providers Pvt Surfaz-SN Triple Action Cream presenting a serious chemical risk.
For the first time, patients with certain types of advanced or recurrent endometrial cancer could access a treatment shown to slow its progression
Cygnus Pharma Ltd. Have informed MHRA that the European Article Number (EAN) barcode printed on various packs of Trazodone Hydrochloride 50mg/5ml Oral Solution, is defective and returns the incorrect information.
Following MHRA approval of a clinical trial, early breast cancer patients on endocrine-based therapy can benefit from a study with camizestrant.
Reported problems with the supply of an animal medicine and the date when the issue is expected to be resolved.
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the medicine piflufolastat (18F) (Pylclari) as a diagnostic tool for people with suspected or known prostate cancer.
The Medicines and Healthcare products Regulatory Agency (MHRA) has today (9 April 2024) approved the medicine fosdenopterin (Nulibry) to treat the genetic disease Molybdenum Cofactor Deficiency (MoCD) Type A
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