EMA has recommended granting a marketing authorisation in the European Union (EU) for Vimkunya, the first vaccine in the EU to protect adolescents from the age of 12 against Chikungunya. This vaccine, also intended for adults, is given as a single dose.
From January 31 2025, all clinical trials in the European Union (EU), including ongoing trials that were approved under the previous legal framework, the Clinical Trials Directive (CTD), are governed by the Clinical Trials Regulation (CTR). This marks the end of a three-year transition period, during which more than 5,000 clinical trials were transitioned to …
EMA: Clinical Trials Regulation becomes fully applicable Read More »
Updated Phase III analysis show that Itovebi TM (inavolisib) in combination with palbociclib (Ibrance®) and fulvestrant provided a statistically significant and clinically meaningful overall survival benefit in a type of HR-positive advanced breast cancer. This was compared to palbociclib and fulvestrant only.
The National Institute for Health and Care Excellence (NICE) has issued positive final draft guidance for a one-off gene therapy which provides a potential cure for certain patients with severe sickle cell disease. This approval of CASGEVY® (exagamglogene autotemcel) is indicated for individuals 12 years and older who have certain types of severe sickle cell …
NICE recommends gene therapy for severe sickle cell disease Read More »
The U.S. Food and Drug Administration approved Journavx (suzetrigine), a first-in-class non-opioid analgesic to treat moderate to severe acute pain in adults. Acute pain is short-term pain that is typically in response to some form of tissue injury, such as trauma or surgery.
