CHICAGO —The combination of ribociclib (Kisqali) and endocrine therapy has already been shown to yield a significant survival advantage for women with metastatic, hormone receptor–positive, HER2-negative […]
Share on PinterestPrime Energy drink contains between 5-7 times the amount of caffeine as a similar serving of the average soft drink. Mike Kemp/In Pictures via […]
CHICAGO — Irrespective of the number of infliximab switches, multiple, successive switches from infliximab originator to biosimilars are effective and safe in patients with inflammatory bowel disease […]
The information below should be included in the RDEA meeting package. The sponsor should indicate in their RDEA meeting package if any items listed below do […]
The RDEA Pilot Program proposal should include a one to two page(s) executive summary and be no longer than 12 pages long. The information below should […]
The quarterly submission deadlines for proposals to the Rare Disease Endpoint Advancement Pilot Program are March 31, June 30, September 30, and December 31. Sponsors may […]
Before FDA grants the initial meeting under the RDEA Pilot Program, the Agency and the sponsor must agree on the information that FDA may disclose publicly. […]
CHICAGO — Only 1%-3% of patients who have had bariatric surgery take Food and Drug Administration–approved antiobesity medications even though 25% of patients experience significant weight […]
A new hair loss treatment has been released in Europe that uses RNA technology to help reverse hair loss. In theory the treatment can target androgen […]
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