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June 2, 2023

Ribociclib Forestalls Recurrence Also in Early Breast Cancer Ribociclib Forestalls Recurrence Also in Early Breast Cancer

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 […]
June 2, 2023

Why Prime and Other Energy Drinks Can be Dangerous – Especially for Kids

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 […]
June 1, 2023

Biologic-to-Biosimilar Switches Deemed Safe and Effective Biologic-to-Biosimilar Switches Deemed Safe and Effective

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 […]
June 1, 2023

Content and Format of the RDEA Meeting Request and Package | Rare Disease Endpoint Advancement Pilot Program

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 […]
June 1, 2023

Content and Format of the RDEA Proposal | Rare Disease Endpoint Advancement Pilot Program

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 […]
June 1, 2023

Submission Deadlines and Process | Rare Disease Endpoint Advancement Pilot Program

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 […]
June 1, 2023

RDEA Pilot Program Disclosure Agreement | Rare Disease Endpoint Advancement Pilot Program

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. […]
June 1, 2023

Few Patients Take Anti-Obesity Meds After Bariatric Surgery Few Patients Take Anti-Obesity Meds After Bariatric Surgery

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 […]
June 1, 2023

A New $330 RNA Hair Loss Product Just Went on Sale in Europe — What to Know About CosmeRNA

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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