A pair of big pharma companies have become the latest drugmakers to take aim at the National Institute for Health and Care Excellence (NICE), the cost-effective 5 March 2024
A preliminary report from the US Food and Drug Administration could raise concerns about the safety of new vaccines for respiratory syncytial virus (RSV). 5 March 2024
The National Institute for Health and Care Excellence (NICE) has decided not to recommend Xenpozyme (olipudase alfa) as a treatment for acid sphingomyelinase de 5 March 2024
All manufacturers participating in the first cycle of Medicare drug price negotiations have responded with counter offers, according to the US Department of Hea 5 March 2024
In another legal blow for opponents of the Inflation Reduction Act (IRA), a federal judge has now rejected a bid from AstraZeneca to prevent price negotiations 4 March 2024
The European Medicines Agency (EMA) has validated two marketing authorization applications (MAAs) for AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan (D 4 March 2024
Drugmakers, patient advocate groups, policymakers and others have come together for Rare Disease Day, which took place at the end of February, to both celebrate 4 March 2024
There is a ray of hope for sickle cell disease (SCD) patients in the UK, after the British health technology assessor re-opened its review into Oxbryta (voxelot 1 March 2024
New regulatory guidance will be of interest for the increasing number of drugmakers investing ever more R&D capital into antibody-drug conjugates (ADC). 1 March 2024
Xandra Neuberger, associate director, regulatory affairs and international service lead for clinical trial applications at PharmaLex, provides an Expert View. 29 February 2024
Last month, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the refusal of the marketing authorization f 29 February 2024
USA-based Insmed (NASDAQ CM: INSM) is a biopharmaceutical company on the development and commercialization of novel, targeted inhaled therapies for patients with serious rare diseases.
Sign up to receive email updates Join industry leaders for a daily roundup of biotech & pharma news