USA – FDA guidance explores trial design, supporting data for GVHD treatments
In preparation for a potential “paradigm shift” in the management of graft-versus-host disease (GVHD), the US Food and Drug Administration (FDA) is seeking comment...
UK – BMS’ Sotyktu gets NICE green light for NHS use
The therapy becomes an option for moderate-to-severe plaque psoriasis in certain adults
Bristol Myers Squibb (BMS) has announced that the National Institute for Health and...
USA – Cell therapy equipment: regulatory guidelines and feedback opportunities
Cell therapy manufacturing requires specialized equipment to prioritize cell health, yield, and performance. A range of suppliers offer tailored equipment, but evolving regulatory guidance...
USA – FDA offers new guidance on therapeutic equivalence evaluations
In draft guidance issued on Wednesday, the US Food and Drug Administration (FDA) explains its approach to therapeutic equivalence (TE) evaluations and the assignment...
USA – Medtech groups want more time to implement FDA’s QMSR rule
Medical device lobby groups say they support the US Food and Drug Administration’s plan to align its Quality System Regulations (QSR) with the international...
Europe – Commission proposes new measures for the better lifecycle management of medicine authorisations
The Commission has proposed to amend the variation legislation for medicines, to make the lifecycle management of medicines more efficient and better adapted to the...
Europe – First adapted COVID-19 booster vaccines recommended for approval in the EU
EMA’s human medicines committee (CHMP) has recommended authorising two vaccines adapted to provide broader protection against COVID-19. Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron...
Europe – New vaccine to protect people in the EU and worldwide against dengue
EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dengue Tetravalent Vaccine (live, attenuated) Takeda, used to prevent disease caused by dengue...
Europe – EMA Q&A addresses submission of data elements for raw data pilot
The European Medicines Agency (EMA) this week issued a question-and-answer guidance to address sponsors’ questions on its pilot testing the review of raw clinical...
USA – FDA ramps up monitoring in high-risk areas following DEG-contamination deaths overseas
The US Food and Drug Administration (FDA) is ramping up its monitoring of firms in areas of the world considered high risk for manufacturing...
