Drug Development Drug Trials Marketing Regulations 
Drug Discovery World
NOVEMBER 3, 2023
New UK therapy option for hard-to-treat lymphoma The MHRA has granted conditional marketing authorisation for Abbvie’s Tepkinly (epcoritamab) as a bispecific treatment for adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
Agency IQ
AUGUST 23, 2024
The office, which is responsible for directly reviewing and regulating medical devices and diagnostics, was established under a major restructuring of CDRH in 2018-2019 as part of CDRH’s “Total Product Lifecycle (TPLC)” approach. There are several high-level takeaways from these updates for drug developers.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Drug Target Review
OCTOBER 3, 2024
Aside from the advent of complex antibody-based drugs, the industry is facing some additional changes which are shaping drug development. 3 This change signals a major shift away from animal use in drug safety regulation and encourages the use of alternative methods like organ-on-chip or other animal-free technologies.
Alta Sciences
JULY 31, 2024
Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. These are just some examples that highlight the critical importance of diversity in clinical trial data for the medicines reaching the market.
Agency IQ
FEBRUARY 2, 2024
Diagnostics landscape analysis: Key issues and a look ahead at 2024 Diagnostic regulation in the U.S. Following significant policy proposals in recent years, 2024 is gearing up to be a profoundly impactful year for diagnostics developers and the policymakers who regulate them. is a constantly evolving topic. In the U.S.,
Expert insights. Personalized for you.
130 
Let's personalize your content