Less than a week after announcing 3 new guidance documents to streamline the review of digital health, the FDA is moving to refine its 510(k) medical device approval pathway.
The Philippines has suspended the sale and distribution of Sanofi’s dengue vaccine, authorities said on Tuesday, after the French pharmaceutical giant last week warned it could worsen symptoms for people who had not previously been infected.
Shares of Sage Therapeutics have shot up more than 75 percent this morning after the company announced positive topline results for its Phase II treatment for patients with moderate to severe major depressive disorder (MDD).
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.
Medical researchers are increasingly turning to mobile devices such as smartphones and watches as a way to monitor patients in trials, an approach they hope improves participation and accuracy but that also has limitations.
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.
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.
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.
Obsidian Therapeutics, Inc., a biotechnology company dedicated to the development of next-generation cell and gene therapies with pharmacologic operating systems, announced the completion of a $49.5 million Series A financing to further build its technology platform and advance its lead programs toward clinical development.
Exonics Therapeutics closed on a $40 million Series A financing. It was led by The Column Group.
Go to Page Go
your submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.