news
CHMP meeting highlights – February 2025
The Committee for Medicinal Products for Human Use (CHMP) recommended approval of four new medicines plus the extension of therapeutic indications for 16 medicines.
List view / Grid view
Drug Safety
news
Greener method for ethylene oxide manufacture identified
The cleaner method could significantly lower production costs and reduce carbon dioxide emissions resulting from ethylene oxide manufacturing.
news
NICE recommends novel immunotherapy for leukaemia
The agency’s decision means eligible adult patients in the UK are set to access the combination immunotherapy as a new treatment option for acute lymphoblastic leukaemia (ALL).
news
First-in-human data for gene therapy signals potential in childhood blindness
Developed and manufactured under a Manufacturer’s ‘Specials’ Licence (MSL), the gene therapy could provide a novel treatment option for paediatric patients at the earliest stage of the rare eye disease.
news
First-of-a-kind EU approval granted for oral small molecule
The authorisation provides a new disease modifying treatment option for European patients with the progressive condition.
news
Adaflex: first UK-licensed melatonin for children with insomnia and ADHD
The drug provides a regulated treatment option for families in the UK impacted by sleep disorders related to ADHD.
news
Biologic could reduce treatment burden for children with haemophilia A
New data suggests that once-weekly prophylaxis bispecific antibody treatment could provide an efficient and convenient option for young patients with haemophilia A.
news
Novel drug approved for diabetes-related vision loss
The monoclonal antibody treatment is now approved in the US for both diabetic macular oedema and wet, or neovascular age-related macular degeneration.
news
Draft regulatory guidance on personalised cancer therapies published
The new draft guidance for personalised cancer therapies addresses the questions that this new regulatory pathway creates, according to the MHRA’s Chief Executive.
news
MHRA approves SARCLISA for newly diagnosed multiple myeloma
SARCLISA (isaxtuximab) provides a new first-line treatment option for patients with multiple myeloma, offering significant improvements in progression-free survival.
news
CHMP meeting highlights – January 2025
In its January meeting, the EMA’s human medicines committee recommended eight new medicines, including biosimilars and a new vaccine.
news
NICE recommends gene therapy for severe sickle cell disease
The committee’s approval of the one-time gene therapy means the healthcare inequalities for patients with this genetic blood disorder can begin to be re-addressed.
news
UK enhances ILAP to accelerate access to innovative medicines
The MHRA’s refreshed guidance is the only end-to-end access pathway that enables medicine developers to collaborate with the national health system, Regulator, and HTA bodies.
news
New analysis asserts survival benefit for Roche breast cancer therapy
The new data highlights the potential of the ItovebiTM (inavolisib)-based regimen as a new standard of care in advanced PIK3CA-mutated, HR-positive, HER2-negative breast cancer.
news
Biologic demonstrates “tremendous” potential advance in atrial fibrillation
The Phase II study validated an “incredibly safe bleeding profile” for Factor XI inhibitors as a treatment for the common cardiovascular condition.
