(IN BRIEF) Novartis has announced that its Phase III PSMAddition trial of Pluvicto™ in combination with standard of care (SoC) has met its primary endpoint, showing a significant benefit in radiographic progression-free survival (rPFS) and a positive trend in overall … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, Marketing, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged androgen receptor pathway inhibitors, cancer research, clinical trials, FDA approval, FDA regulatory review, metastatic castration-resistant prostate cancer, metastatic hormone-sensitive prostate cancer, mHSPC, Novartis, Novartis oncology, overall survival, Phase III PSMAddition, Pluvicto, progression-free survival, prostate cancer, prostate cancer treatment, PSMA-positive, radioligand therapy, treatment options
(IN BRIEF) Sanofi’s Dupixent has been granted FDA priority review for the treatment of bullous pemphigoid (BP), a chronic skin disease. If approved, Dupixent would be the first targeted medicine for BP in the U.S., with the FDA’s decision expected … Read the full press release
Posted in Business, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged bullous pemphigoid, chronic conditions, clinical trial, corticosteroid, disease remission, Dupixent, Dupixent sBLA, FDA approval, FDA priority review, orphan drug designation, regulatory news, Sanofi, skin disease, targeted treatment
(IN BRIEF) Roche has announced that the FDA has expanded the approval of its PATHWAY® HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test to identify HER2-ultralow status in HR-positive, HER2-negative metastatic breast cancer patients. This new approval offers a potential treatment … Read the full press release
Posted in Business, Financial, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Switzerland, Technology
Tagged breast cancer, DESTINY-Breast06 trial, diagnostic solutions, Enhertu, FDA, FDA approval, HER2-Low, HER2-targeted therapy, HER2-Ultralow, HR-positive, metastatic breast cancer, PATHWAY HER2, Personalized Treatment, Roche, treatment options
(IN BRIEF) Sanofi’s Sarclisa has been approved by the European Union as the first anti-CD38 therapy in combination with VRd to treat adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. This approval is … Read the full press release
Posted in Business, European Union, Financial, France, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged CD38 monoclonal antibody, clinical development, clinical trials, European Union approval, FDA approval, hematologic malignancies, immunoscience, isatuximab, Multiple Myeloma, NDMM, oncology, orphan drug exclusivity, Sanofi, Sarclisa, transplant-ineligible, treatment breakthrough, VRd
(IN BRIEF) QIAGEN has announced FDA clearance for its QIAstat-Dx Respiratory Panel Mini, marking the third such approval for the QIAstat-Dx system in 2024. Tailored for outpatient settings, this panel quickly detects five common respiratory pathogens—including influenza strains and SARS-CoV-2—enabling … Read the full press release
Posted in Business, Financial, Government, Healthcare, Industrial, Investment, Management, Netherlands, News, Pharma & Biotech, Science, Security & Safety, Technology
Tagged FDA approval, influenza strains, Nadia Aelbrecht, Outpatient Respiratory Diagnostics, QIAGEN, QIAstat-Dx Mini Panel, Rapid Results, safety, SARS-CoV-2
(IN BRIEF) The U.S. Food and Drug Administration (FDA) has granted approval for Dupixent® (dupilumab) to treat pediatric patients aged 1 to 11 years, weighing at least 15 kg, who suffer from eosinophilic esophagitis (EoE). Dupixent is now the first … Read the full press release
Posted in Business, Education, Financial, France, Government, Healthcare, Industrial, Investment, Management, News, Pharma & Biotech, Science, Technology
Tagged dupilumab, Dupixent, Eosinophilic Esophagitis (EoE) Treatment, FDA approval, George D. Yancopoulos, Naimish Patel, pediatric, Regeneron, Sanofi
(IN BRIEF) Roche has announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) under Priority Review. The sBLA is for the reduction of allergic reactions, including anaphylaxis, caused by … Read the full press release
Posted in Business, Healthcare, Industrial, Management, News, Pharma & Biotech, Science, Switzerland, Technology
Tagged adults, allergic reactions, CHILDREN, FDA approval, Levi Garraway, Multiple Foods, Reducing, Roche, Xolair®
(IN BRIEF) AstraZeneca’s Supplemental Biologics License Application (sBLA) seeking approval for a self- or caregiver-administered option for FluMist Quadrivalent, a needle-free nasal spray flu vaccine, has been accepted for review by the US Food and Drug Administration (FDA). If approved, … Read the full press release
Qtern fixed-dose combination will provide an additional oral medicine option for patients taking Farxiga (dapagliflozin) to improve blood sugar level LONDON, 03-Mar-2017 — /EuropaWire/ — AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved once-daily Qtern (10mg … Read the full press release
Posted in Healthcare, Pharma & Biotech, United Kingdom
Tagged AstraZeneca, Elisabeth Björk, FDA approval, Qtern, treatment of type-2 diabetes
IN.PACT Admiral DCB Indication Expansion to Treat Patients with ISR DUBLIN, 16-Sep-2016 — /EuropaWire/ — Medtronic plc (NYSE: MDT) today announced that the U.S. Food and Drug Administration (FDA) approved the IN.PACT(TM) Admiral(TM) drug-coated balloon (DCB) as a treatment for in-stent … Read the full press release
cobas 6800/8800 Systems offer fastest time to results and highest throughput of any molecular platform, helping to improve disease management and patient care BASEL, 19-10-2015 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received … Read the full press release
Posted in France, Healthcare, Pharma & Biotech
Tagged cobas®, cobas® HBV, FDA approval, HCV viral load tests, Roche
Acromegaly is an endocrine disorder caused by elevated growth hormone (GH) and insulin-like growth factor-1 (IGF-1) levels[1] Signifor LAR, a next-generation somatostatin analog, provides a new option for patients with acromegaly with inadequately controlled disease[2] Signifor LAR FDA approval is … Read the full press release
Posted in Healthcare, Pharma & Biotech, Science, Switzerland
Tagged acromegaly, Bruno Strigini, Dr. Monica Gadelha, FDA approval, hormonal disorder, Novartis, Signifor® LAR
Expanded indication makes cobas HPV Test the only test approved in U.S. that can be used instead of Pap in first-line primary screening in women 25 and older Basel, 29-4-2014 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that … Read the full press release
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