News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…

This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…

Phase I data for TERN-601 suggests Terns’ oral GLP-1 candidate for obesity could be a contender in the market next to big names like Lilly, Pfizer and Roche.

Terns Pharmaceuticals will advance TERN-601 into Phase II after early-stage data showed the oral therapy led to weight loss of 4.9%, comparable with weight loss pills Lilly and Pfizer are developing, according to analysts.

In 2023, the FDA greenlit 55 new drugs and 34 cell and gene therapies. Follow along as BioSpace keeps you up to date on all of the FDA’s decisions in 2024.

Set to start in 2025, Relay Therapeutics is moving toward a pivotal study of experimental treatment RLY-2608 in heavily pretreated locally advanced or metastatic breast cancer.

EMA recommends measures to minimise serious outcomes of known side effect with painkiller metamizoleProduct information to be updated to raise awareness of known risk of…, Agenda Agenda of the PRAC meeting 2-5 September 2024DraftReference Number: EMA/PRAC/323875/2024 English (EN…, PRAC statistics: September 2024 , PRAC statistics: September 2024 English (EN) (33.15 MB – PDF)First published: 06/09/2024View, Glossary Safety signal assessments. A safety signal is information which suggests a new potentially causal association, or a new aspect of a known association…, Ongoing referrals ProcedureStatusUpdateMetamizole containing medicinal products – referralUnder evaluationPRAC continued its assessment

UPDATE: Evaluating Plastic Syringes Made in China for Potential Device Failures: FDA Safety Communication

EMA and the Heads of Medicines Agencies (HMA) have published high-level principles and recommendations for all staff across the European medicines regulatory network (EMRN) using…

McGrath MAC Video Laryngoscopes help visualize the trachea and larynx. The batteries on these devices may deplete too much, causing overheating and explosion.

Vivo 45 LS ventilators support breathing in homes and health settings. New devices may expose users to elevated formaldehyde levels for a short time.

FreeStyle Libre 3 sensor provides continuous monitoring of glucose levels but a small number of sensors may give inaccurate high readings

Proceeds from the oversubscribed financing will be used to advance ArsenalBio’s lead programs, which include a handful of solid tumor cell therapy candidates.

ImmunityBio will lay off 16 employees in El Segundo, California, and said it expects to need more funding to commercialize Anktiva, approved in April for non-muscle invasive bladder cancer.

The Volara System provides lung therapy for patients on ventilators but some single-patient use circuits and blue ventilator adapter assemblies may disconnect.

Smiths Medical issued an Urgent Medical Device Notification on May 29, 2024, to notify affected customers of a potential issue with certain Bivona® Tracheostomy Tubes

Outside of working hours and on public holidays, it is possible to call the product emergency hotline on +31(0)88 781 7600.Please note that this is an emergency number that should…

IMDRF Working Group Updates to the 24th IMDRF MC Session available for review and feedback

New article promoting RSS Feeds

23rd MC Meeting – Brussels Outcome Statement

White Paper – 23rd IMDRF Session Joint Workshop by IMDRF – DITTA and GMTA – Importance of post-market related activities

Eligible regulatory authorities can now apply to become IMDRF Affiliate Members