(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
(IN BRIEF) Sanofi has received FDA priority review for the new drug application for venglustat, an investigational oral glucosylceramide synthase inhibitor being developed for type 3 Gaucher disease. The FDA’s target action date is 25 November 2026. If approved, venglustat … Read the full press release
Posted in European Union, France, Healthcare, Marketing, Pharma & Biotech
Tagged adult patients, ataxia, biopharma, blood-brain barrier, breakthrough therapy designation, central nervous system, cerebrospinal fluid, cognitive deficits, enzyme replacement therapy, ERT, EURONEXT: SAN, Fabry disease, Fast Track Designation, FDA, Gaucher disease, GCSi, GD3, GL1, glucosylceramide synthase inhibitor, glycosphingolipids, GSL, haemoglobin, LEAP2MONO, liver volume, lyso-GL1, lysosomal storage disease treatments, lysosomal storage disorder, Nasdaq SNY, NCT05222906, NDA, neuroinflammation, neurological manifestations, New Drug Application, orphan designation, paediatric patients, Paris, phase 3 study, platelet count, Priority Review, rare diseases, Sanofi, Sanofi Builds Rare Disease Pipeline as FDA Accepts Venglustat Application for Priority Review in GD3, Sanofi’s Venglustat Could Become First U.S. Treatment Targeting Neurological Symptoms of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Potential Treatment of Type 3 Gaucher Disease, Sanofi’s Venglustat Receives FDA Priority Review for Type 3 Gaucher Disease Treatment in the United States, spleen volume, type 3 Gaucher disease, U.S. Food and Drug Administration, venglustat, WORLDSymposium
(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged 2022 San Antonio Breast Cancer Symposium, AstraZeneca, breast cancer, CAPItello-291 Phase III, capivasertib, CDK4/6 inhibitors, endocrine therapies, Faslodex, FDA, Food and Drug Administration, fulvestran, hormone receptor, metastatic breast cancer, NDA, New Drug Application, Priority Review, Susan Galbraith, The New England Journal of Medicine
PARIS, 16-7-2015 — /EuropaWire/ — Today (July 15, 2015), NuGeneration Ltd (NuGen), owned 60% by Toshiba and 40% by ENGIE, made payment to the Nuclear Decommissioning Authority (NDA), as part of a land contract for the Moorside site in West … Read the full press release
London, UK, 23-10-2013 — /EuropaWire/ — GlaxoSmithKline plc (LSE:GSK) today announced the submission of a New Drug Application (NDA) in the US for the once daily inhaled corticosteroid (ICS) treatment, fluticasone furoate (FF), administered using the ELLIPTA™ dry powder inhaler. The NDA … Read the full press release
Posted in Government, Healthcare, Pharma & Biotech, Science, United Kingdom
Tagged asthma, Bradd Pavur, Catherine Hartley, David Daley, David Mawdsley, ELLIPTA™, ELLIPTA™ dry powder inhaler, fluticasone furoate (FF), fluticasone furoate monotherapy, Gary Davies, GlaxoSmithKline, GlaxoSmithKline plc, GSK, James Dodwell, Jeff McLaughlin, Juan Carlos Molina, Karen Collins, Kirsty Collins (SRI & CG), LSE:GSK, Lucy Singah, Melinda Stubbee, NDA, New Drug Application (NDA), once daily inhaled corticosteroid (ICS) treatment, Simon Steel, Stephen Rea, Tom Curry, US FDA, US regulatory submission, Ziba Shamsi
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