(IN BRIEF) Roche has received FDA acceptance under Priority Review for its New Drug Application for giredestrant as an adjuvant treatment for adults with ER-positive, HER2-negative stage I-III breast cancer. The FDA is expected to decide on the application by … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Marketing, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged adjuvant treatment, American Society of Clinical Oncology Congress, ASCO 2026, Basel, breast cancer research, CDK4/6 inhibitor, early stage breast cancer, endocrine therapy, ER-positive breast cancer, ESR1-mutated breast cancer, evERA Breast Cancer, everolimus, FDA, FDA Accepts Roche’s Giredestrant Application as Potential New Adjuvant Treatment for Early-Stage Breast Cancer, FDA Sets November 2026 Decision Date for Roche’s Giredestrant in Early-Stage ER-Positive Breast Cancer, giredestrant, HER2-negative breast cancer, hyaluronidase, iDFS, invasive disease-free survival, Levi Garraway, lidERA Breast Cancer, NDA, New Drug Application, oncology, overall survival, Palbociclib, PDUFA, pertuzumab, Phesgo, Prescription Drug User Fee Act, Priority Review, Roche, Roche Moves Forward With Giredestrant Filing in Curative-Intent Breast Cancer Treatment Setting, Roche Secures FDA Priority Review for Giredestrant in Early-Stage ER-Positive Breast Cancer, selective oestrogen receptor degrader, SERD, stage I breast cancer, stage II breast cancer, stage III breast cancer, targeted therapy, trastuzumab, United States Food and Drug Administration
Lexington, Mass., USA, 20-Jan-2017 — /EuropaWire/ — Shire plc (LSE: SHP, NASDAQ: SHPG) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of the Class 2 resubmission of a New Drug Application (NDA) for SHP465, a long-acting, triple-bead, … Read the full press release
Posted in Healthcare, Ireland, Pharma & Biotech
Tagged ADHD, Andrew J. Cutler MD, New Drug Application, PDUFA, Philip Vickers PhD, Prescription Drug User Fee Act, Shire plc, SHP465, U.S. FDA
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