Remove 2017 Remove FDA Approval Remove Research
article thumbnail

Pirtobrutinib

New Drug Approvals

7] Pirtobrutinib was approved for medical use in the United States in January 2023, [4] [8] [9] [10] and in the European Union in November 2023. [2] Compounds useful as kinase inhibitors (WO 2017/103611 A1). Food and Drug Administration (FDA). 5] It is taken by mouth. [1] 2] PATENTS Guisot, N. 1 December 2023. August 2023).

article thumbnail

The Role of the FDA’s Oncology Center of Excellence in Advancing Cancer Care

The Premier Consulting Blog

The FDAs Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. Resulting ideas will be shared with those interested in implementing them.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

U.S. FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients

The Pharma Data

FDA Approves New Indication for Merck’s PREVYMIS® (letermovir) for Prevention of Cytomegalovirus (CMV) Disease in High-Risk Adult Kidney Transplant Recipients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Source link: [link]

article thumbnail

FDA approves Roche’s Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

The Pharma Data

. “The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, M.D., Jude Children’s Research Hospital. Food and Drug Administration in 2017.

article thumbnail

PRITELIVIR MESYLATE

New Drug Approvals

Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Research and Development: Pritelivir is being developed by AiCuris Anti-infective Cures, building upon research from Bayer. PAPER By: Carta, Fabrizio ; et al.

57
article thumbnail

An Evolving Regulatory Environment for Rare and Orphan Diseases

Advarra

Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Food and Drug Administration (FDA) approval. These centers, in conjunction with the FDA and U.S.

Disease 52
article thumbnail

Radius Health, Inc. Announces Acquisition of Orphan Disease Program

The Pharma Data

based contract manufacturing business, Benuvia Manufacturing, which has significant chemistry and formulation capabilities, including manufacturing our FDA-approved cannabinoid drug, SYNDROS ® ,” said Todd C. We look forward to supporting Radius through our U.S. Davis, executive chairman of Benuvia. Disease Highlights.

Disease 52