UK – MHRA announces new recognition routes to facilitate safe access to new medicines...
New regulatory recognition routes for medicines will be established using approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and the United States,...
USA – FDA Approves First Oral Antiviral for Treatment of COVID-19 in Adults
Today, the U.S. Food and Drug Administration approved the oral antiviral Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) for the treatment...
UK – Regulatory approval of Pfizer/BioNTech vaccine for COVID-19
There are four presentations of the original COVID-19 Vaccine Pfizer/BioNTech authorised for use in Great Britain, three of which are currently available and all...
International – ICH S5 (R3) Guideline on detection of reproductive and developmental toxicity for...
The purpose of this document is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART)...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
UK – Bayer’s Nubeqa combination recommended by NICE to treat metastatic prostate cance
The final draft guidance from NICE specifically recommends Nubeqa tablets in combination with androgen deprivation therapy (ADT) and docetaxel.
The decision follows the Medicines and...
USA – Dual draft guidances outline FDA vision for pediatric drug development, exclusivity
In a move that could ruffle the feathers of pharmaceutical companies, the US Food and Drug Administration (FDA) says it aims to be more...
UK – AstraZeneca’s heart failure treatment recommended by NICE for expanded use
Forxiga, sold as Farxiga in certain markets, has previously been recommended by NICE as a treatment option for HF patients with reduced ejection fraction...
UK – MSD and Eisai’s combination therapy recommended by NICE for advanced endometrial cancer
The combination therapy is specifically indicated for adults with advanced or recurrent endometrial cancer whose disease has progressed on or after platinum-based chemotherapy and...
UK – AbbVie’s Rinvoq recommended by NICE for Crohn’s disease
The authorisation, which makes Rinvoq the first oral Janus Kinase (JAK) inhibitor available for this indication in England and Wales, specifically applies to patients...
