The FDA Accelerated Approval pathway, which has been pivotal in enabling early access to new oncology drugs over the past three decades, has recently come under increased scrutiny. New draft guidance published in March 2023 offers several possible solutions to improve this pathway, with the ultimate...
FDA Grants Accelerated Approval for Tecelra (afamitresgene autoleucel) Cell Therapy for the Treatment of Synovial Sarcoma PHILADELPHIA & OXFORD, England--(BUSINESS WIRE) August 01, 2024 -- Adaptimmune Therapeutics plc (NASDAQ: ADAP), a company working to redefine the treatment of solid tumor can...
Jun 13, 2024 02:17 New treatment gives hope to cancer patients once considered terminal It's called TIL therapy, and it recently received FDA approval. CBS's Michael George introduces us to one patient who participated in clinical trials. Jun 3, 2024 01:55 Supreme Court hears arguments...
agreement and/or by regulatory authorities such as the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA). This includes regulations concerned with the development, approval, manufacturing and marketing of drugs...
AngioDynamics receives FDA approval to initiate NanoKnife DIRECT clinical study for... 12th April 2019 Features Interventional News’ top 10 most popular stories of 2024 10th January 2025 US interventional radiology: 12 years of primary specialty status ...
During the first half (H1) of 2024, the global contract development and manufacturing organization ( FDA approvals slump 19% in H1 2024; NASH, COPD, PAH get new treatment options The first half of 2024 saw a significant slowdown in approvals of new drugs and biologics by the US FDA’s...
FDA updates Ozempic label with potential blocked intestines side effect The FDA stopped short of saying the potentially life-threatening condition was caused by the drugs, which have become popular for weight loss. Sep 28, 2023 FDA declines approval bid for Neffy, a needle-free EpiPen altern...
The FDA just cleared the way for drug importation. What now? Health Care Florida gets FDA approval for Canadian drug importation plan Cannabis Why fears about Biden’s marijuana moves are overblown Agriculture Applesauce pouches may have been contaminated on purpose, FDA foods chief says ...
Johnson & Johnson MedTech Announces CE Mark Approval for Dual Energy THERMOCOOL SMARTTOUCH™ SF Catheter January 9, 2025 Nipocalimab granted U.S. FDA Priority Review for the treatment of generalized myasthenia gravis January 8, 2025 Johnson & Johnson Statement on VARIPULSE™ U.S. Exte...
Human intestinal immuno-organoids Chiara Anania Research Highlights11 Sept 2024Nature Genetics Volume: 56, P: 1765 ‘Contribution of component’ and the perioperative immune-checkpoint inhibitor precedent The FDA approval of perioperative pembrolizumab, an approach that combines neoadjuvant and adjuvant thera...