The U.S. Food and Drug Administration(FDA) expanded the approved use of Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis, an inflammation in the wall of blood vessels of the body. This new indication provides the first FDA-approved therapy specifically to treat EGPA.
The final FDA guidance on design consideration and pre-market submission for interoperable medical devices was released on September 6. The demand for these devices is increasing in the healthcare system as our dependence on more rapid and protected interactions between devices grows. This increase presents a need for a parallel increase in adequate FDA regulations for this elaborate device field.
Approval based on data from the Phase III RESORCE study where Stivarga® (regorafenib) demonstrated significant improvement in overall survival in hepatocellular carcinoma (HCC) patients previously treated with Nexavar® (sorafenib)
The light-sensitive layer found at the back of a person's eyes contains more than just cells that detect shadows and light — it also contains information about the health of a person's entire body. And now, artificial intelligence can glean this information from a single snapshot, new research suggests.
Gilead Sciences, Inc. GILD and its newly acquired cell therapy subsidiary -Kite Pharma- announced that they have inked an agreement to acquire Cell Design Labs, Inc. for $567 million. Gilead will also acquire 12.2% of Cell Design shares which are owned by Kite Pharma.
A new report has found that there are more than 2,000 immunotherapy drugs now in development for cancer, with 940 of these in clinical stage development and 1,064 at the preclinical stage.
The Draft Amendment to Order 650 published by CFDA last month brings some good news around the streamlined reviews of medical device submissions in China and especially for manufacturers of Innovative Devices. Not only will manufacturers of innovative medical devices be exempted from providing proof of sales abroad to CFDA, the mandatory local type testing requirements are also abolished. Nevertheless, there still exist some challenges for the unwary.
electroCore, a U.S.-based bioelectronic medicine healthcare company advancing better patient therapies through superior approaches to neuromodulation, has announced it completed its Series B financing that has brought in just over $70 million of capital to the company.
FDA Commissioner Scott Gottlieb, MD, today announced 3 policy changes meant to encourage digital health innovation while modernizing the agency’s oversight of new tech.
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
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