(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) GSK has formed an exclusive partnership with Sino Biopharmaceutical subsidiary Chia Tai Tianqing Pharmaceutical Group to accelerate the launch of bepirovirsen, a potential first-in-class treatment for chronic hepatitis B, in mainland China. The agreement combines GSK’s drug innovation … Read the full press release
Posted in Healthcare, Marketing, Pharma & Biotech, Science, United Kingdom
Tagged antisense oligonucleotide, B-Well 1, B-Well 2, Bepirovirsen, biotechnology, breakthrough therapy designation, Chia Tai Tianqing Pharmaceutical Group, China healthcare, chronic hepatitis B, CTTQ, Exclusive GSK Agreement with SBP Group Targets Faster Rollout of Investigational Hepatitis B Therapy, functional cure, global biopharma, GSK, GSK and CTTQ Form Strategic Collaboration to Expand Access to Bepirovirsen Across China, healthcare partnerships, hepatitis B treatment, hepatitis B virus, hepatology, Ionis Pharmaceuticals, liver cancer, liver disease, Mike Crichton, pharmaceutical collaboration, Phase III Trials, Priority Review, regulatory review, SBP Group, Sino Biopharmaceutical, viral hepatitis
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s supplemental Biologics License Application for Enhertu plus pertuzumab has been accepted for Priority Review by the FDA for the first-line treatment of HER2-positive metastatic breast cancer. The application is supported by data from the … Read the full press release
Posted in Business, Healthcare, News, Pharma & Biotech, Science, Technology, United Kingdom
Tagged ADC, antibody-drug conjugate, AstraZeneca, breakthrough therapy designation, cancer treatment innovation, Daiichi Sankyo, DESTINY-Breast09, Enhertu, Enhertu plus pertuzumab moves closer to first-line approval in HER2-positive metastatic breast cancer after FDA Priority Review acceptance, FDA, FDA grants Priority Review to Enhertu plus pertuzumab for 1st-line HER2-positive metastatic breast cancer following DESTINY-Breast09 success, HER2-positive breast cancer, Ken Takeshita, metastatic breast cancer, oncology, pertuzumab, Priority Review, progression-free survival, Real-Time Oncology Review, Susan Galbraith, THP regimen, trastuzumab deruxtecan
(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology, United Kingdom
Tagged advanced NSCLC, antibody-drug conjugate, AstraZeneca, Biologics License Application, BLA, breakthrough therapy designation, Daiichi Sankyo, datopotamab deruxtecan, drug approval, EGFR-mutated, EGFR-tyrosine kinase inhibitors, FDA, metastatic NSCLC, non-small cell lung cancer, NSCLC, objective response rate, oncology, partnership, Phase III Trials, Priority Review, safety profile, systemic therapies, TROP2-directed, TROPION-Lung01, TROPION-Lung05, TROPION-Lung14, TROPION-Lung15
(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
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