Most predictive clinical decision support devices (CDS) that rely on machine learning (ML) or AI are approved and marketed without adequate proof that they deliver on their promise of improving…
A district court has handed a preliminary injunction to EOFlow, blocking it from selling products developed using proprietary information derived from insulin pump maker Insulet — the decision arriving as…
HistoSonics’ Edison System, which uses focused ultrasound to mechanically destroy and liquify unwanted liver tissue and tumors, has received de novo marketing authorization from the FDA and is the first…
Guidance updates, Novo Nordisk complaint against semaglutide compounders tossed, and AdvaMed forms new digital tech division, in this edition of Quick Notes. Source: Drug Industry Daily
Pfizer announced that the FDA has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab), giving pharmacists the ability to substitute it for Humira without intervention from the prescribing…
The FDA has revised the Manual of Policies and Procedures (MAPP) for ANDA assessment practices with changes intended to decrease the number of review cycles needed for approval. Source: Drug…
In a move to strengthen its KRAS-targeting oncology portfolio, Bristol Myers Squibb is buying Mirati, the company that developed and launched Krazati (adagrasib), a best-in-class molecule that, when combined with…
Alnylam Pharmaceuticals today announced that the FDA has issued a complete response letter (CRL) on its supplemental New Drug Application (sNDA) for Onpattro (patisiran) for the treatment of cardiomyopathy of…
The FDA’s plan to modernize its IT infrastructure features several improvements that will benefit clinical trials and sponsors, including upgrades to data-sharing and electronic submissions, support for responsible use of…
As the first session of the 118th Congress continues, FDAnews will track important pending legislation, that has been acted on since July 1, to keep you updated on laws and…