news
MHRA approve first monoclonal antibody treatment for COVID-19
The MHRA have approved Ronapreve as the first monoclonal antibody combination product for the treatment of COVID-19 infection in the UK.
List view / Grid view
Regs & Legs
news
FDA approves Jardiance® for heart failure with reduced ejection fraction
The FDA have approved Lilly’s Jardiance (empagliflozin) to treat adults living with heart failure with reduced ejection fraction.
whitepaper
Worksheet: ARMM technology comparison
This worksheet can be edited to include specifications discovered during your evaluation of Alternative Rapid Microbiological Method Technologies.
news
FDA approve GSK’s Jemperli for patients with dMMR solid tumours
GSK receives FDA accelerated approval for Jemperli for adults with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.
news
MHRA approves COVID-19 Vaccine Moderna in 12-17-year olds
The MHRA has approved the use of the Spikevax vaccine (formerly COVID-19 Vaccine Moderna) in children aged 12-17 years old.
news
ICMRA set out recommendations for AI regulation in medicine
The ICRMA has set out recommendations to help regulators tackle the challenges posed by artificial intelligence (AI) in medicine.
news
Pfizer and BioNTech submit Phase I data to FDA for COVID-19 booster
Pfizer and BioNTech have announced the submission of initial data to the US FDA to support booster dose of COVID-19 vaccine.
news
Drug price reduction could have no impact on future approvals, study finds
New research shows that drug price reductions under the US's H.R. 3 policy could have no impact on innovation in the pharmaceutical industry.
news
FDA approves TicoVac™ tick-borne encephalitis (TBE) vaccine
The FDA has approved Ticovac, a tick-borne encephalitis (TBE) vaccine, for people aged one year and older when travelling to TBE endemic areas.
news
FDA approve a new indication for Xywav to treat chronic sleep disorder
The FDA have granted a first of its kind indication for Xywav for the treatment of idiopathic hypersomnia (IH) in adults.
news
New NICE draft guidance recommends abemaciclib for breast cancer
NICE has published draft guidance recommending Eli Lilly's twice-daily pill abemaciclib for advanced HER2-negative breast cancer.
news
FDA allows additional COVID-19 vaccine dose for immunocompromised
The FDA has authorised an additional dose of COVID-19 Vaccines Pfizer-BioNTech and Moderna in certain immunocompromised patients.
article
ebook: Waiving intellectual property rights for COVID-19-related interventions and technologies: a comprehensive guide
This ebook explores the intellectual property rights waiver for COVID-19 treatments, vaccines, diagnostics and technologies, its potential ramifications for the drug development industry and potential solutions for overcoming COVID-19 vaccination inequalities.
news
MHRA approves Epidyolex® (cannabidiol) for TSC seizure treatment
GW Pharmaceuticals received approval for Epidyolex®(cannabidiol) for the treatment of seizures linked to tuberous sclerosis complex (TSC) in the UK.
news
EMA endorses global facilitation of track and trace systems
The European Medicines Agency has endorsed ICMRA recommendations to facilitate the use of track and trace systems for medicinal products at a global level.
