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NICE Guidance: Olipudase alfa for Niemann-Pick disease types AB and B

NICE has published highly specialised technologies guidance (HST32) on the use of olipudase alfa (Xenpozyme) for treating Niemann-Pick disease types AB and B. The guidance provides evidence-based recommendations for healthcare professionals and commissioners in the UK.

NICE Guidance: Setmelanotide for Bardet-Biedl Syndrome

The UK's National Institute for Health and Care Excellence (NICE) has published highly specialised technologies guidance on setmelanotide (Imcivree) for treating obesity and hyperphagia in Bardet-Biedl syndrome. The guidance provides evidence-based recommendations for patients aged 6 years and over, with specific criteria for treatment initiation.

NICE Guidance: Epcoritamab for Follicular Lymphoma

NICE has published technology appraisal guidance (TA1139) recommending epcoritamab (Tepkinly) for treating relapsed or refractory follicular lymphoma in adults after two or more lines of systemic treatment. The guidance outlines evidence-based recommendations for healthcare professionals.

NICE Guidance: Durvalumab for Muscle-Invasive Bladder Cancer

NICE has published technology appraisal guidance (TA1138) recommending durvalumab with gemcitabine and cisplatin for the neoadjuvant and adjuvant treatment of muscle-invasive bladder cancer. The guidance includes information on commercial arrangements and reporting adverse events.

NICE Guidance on Bevacizumab for Metastatic Colorectal Cancer (TA1136)

NICE has published updated technology appraisal guidance (TA1136) on the use of bevacizumab (originator and biosimilars) with fluoropyrimidine-based chemotherapy for metastatic colorectal cancer. This guidance replaces previous recommendations and provides evidence-based recommendations for healthcare professionals.

Canagliflozin Appraisal Terminated for Type 2 Diabetes in Youth

NICE has terminated the appraisal of canagliflozin (Invokana) for treating type 2 diabetes in individuals aged 10 to 17 years. The appraisal was terminated because the company failed to provide an evidence submission. NICE will review this decision if a submission is made.

Baloxavir marboxil appraisal terminated for children

NICE has terminated the appraisal of baloxavir marboxil for treating and preventing influenza in children aged 1 to 11 years. The decision was made because the company failed to provide an evidence submission for the technology appraisal.

FDA Issues Emergency Use Authorization for Ivomec to Prevent Screwworm in Cattle

The FDA has issued an Emergency Use Authorization (EUA) for Ivomec (ivermectin) injectable solution to prevent New World screwworm infestations in cattle. This authorization allows for over-the-counter use under specific conditions and is effective until the declared emergency is terminated.

FDA Guidance on Defining Drug Use Durations for Medically Important Antimicrobials

The FDA has finalized guidance (GFI #273) recommending how animal drug sponsors can voluntarily establish defined durations of use for medically important antimicrobial drugs administered in feed to food-producing animals. Over 100 drugs are affected, and sponsors are expected to submit revised labeling within approximately three years.

FDA Authorizes Drugs for New World Screwworm in Dogs and Cats

The FDA has issued two Emergency Use Authorizations (EUAs) for NexGard and NexGard COMBO for the treatment of New World screwworm infestations in dogs and cats, respectively. These EUAs are effective until the HHS Secretary terminates the public health emergency declaration for this pest.