Salute e Benessere

Implantica announces U.S. FDA has provided feedback on the final RefluxStop® PMA…

"FDA has now provided its feedback on the final module of our PMA submission for U.S. market approval to sell RefluxStop® in the U.S. The feedback is positive and can be addressed efficiently in our view. We are meeting with FDA on October 3rd to discuss the best path forward in addressing a few outstanding questions and requests. Depending on the outcome of this meeting, we expect to provide our responses to FDA's feedback within a timeframe ranging from a few weeks to a few months. We are…
PR Newswire
24/09/2025

Correction of a Material Error Relating to the Total Number of Voting Rights and…

Correction of a Material Error Relating to the Total Number of Voting Rights and Shares Comprising the Share CapitalClarification in Response to Unfounded Accusations NANTES, France – September 24, 2025, 8:00 a.m. CET – OSE Immunotherapeutics SA(ISIN: FR0012127173; Mnemo: OSE) corrects the information relating to the total number of shares and voting rights comprising its share capital. As part of the preparation for the General Meeting on September 30, 2025, OSE identified a...
Nasdaq GlobeNewswire
24/09/2025

Synendos Therapeutics Reports Positive and Highly Promising Topline Results from…

The studies established the lead asset to be well tolerated in healthy volunteers at all doses with a good safety profileSYT-510 demonstrated penetration in the central nervous system and a pharmacodynamic effect on the brain BASEL, Switzerland, Sept.24, 2025(GLOBE NEWSWIRE) -- Synendos Therapeutics (“Synendos”), the clinical-stage biotech company developing breakthrough therapies for neuropsychiatric disorders, announced today topline results for its lead asset, SYT-510, a...
Nasdaq GlobeNewswire
24/09/2025

Press Release: Sanofi commits an additional $625 million to Sanofi Ventures to…

Sanofi commits an additional $625 million to Sanofi Ventures to accelerate investment in biotech and digital health innovationThe fund will remain focused on Sanofi's key areas of immunology, rare diseases, neurology, and vaccines, backing earlier-stage innovation and emerging opportunities that support the company’s long-term strategySanofi Ventures drives innovation through leading and participating in private financing rounds for pioneering healthcare companiesParis, September 24, 2025...
Nasdaq GlobeNewswire
24/09/2025

Press release: Availability of the Q3 2025 Aide mémoire

Availability of the Q3 2025 Aide mémoireParis, France – September 24, 2025. Sanofi announced today that its Q3 2025 Aide mémoire is available on the "Investors" page of the company's website: Third quarter 2025 (sanofi.com) As for each quarter, Sanofi prepared this document to assist in the financial modelling of the Group's quarterly results. This document includes a reminder on various non-comparable items, as well as the foreign currency impact and share count. Sanofi's second...
Nasdaq GlobeNewswire
24/09/2025

BMC Medical Showcases Innovations in Sleep and Respiratory Care at ERS 2025 in…

Alongside the exhibition, BMC will host a sponsored workshop session:"The Future of CPAP Monitoring: What Needs to Change Today?"Tuesday, September 15, 14:00–14:45 | Room E103–104 Alongside the exhibition, BMC will host a sponsored workshop session: "The Future of CPAP Monitoring: What Needs to Change Today?"Tuesday, September 15, 14:00–14:45 | Room E103–104 The session will feature leading experts including: The discussion will explore the transition from a one-size-fits-all…
PR Newswire
24/09/2025

SGLT2 Inhibitors Market to Expand by 2034 as Companies Leverage Emerging…

Key Takeaways from the SGLT2 Inhibitors Market Report Key Takeaways from the SGLT2 Inhibitors Market Report Discover which indication is expected to grab the major SGLT2 inhibitors market share @SGLT2 Inhibitors Market Report Key Factors Driving the SGLT2 Inhibitors Market Growing SGLT2 inhibitors target population Global diabetes prevalence and the rising burden of CKD and heart failure expand the addressable market; demographic trends (aging population, obesity) magnify demand...
PR Newswire
23/09/2025

Biogen Provides Regulatory Update on High Dose Regimen of Nusinersen

BiogenInc. (Nasdaq: BIIB) today announced that the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) for the Company’s supplemental New Drug Application (sNDA) for the high dose regimen of nusinersen for the treatment of spinal muscular atrophy (SMA). The FDA letter requested an update to the technical information be included in the Chemistry Manufacturing and Controls (CMC) module of the sNDA.The letter did not cite any deficiencies in the clinical data of...
Nasdaq GlobeNewswire
23/09/2025

OSE Immunotherapeutics acknowledges the decision of the Nantes Commercial Court

OSE Immunotherapeutics acknowledges the decision of the Nantes Commercial CourtNANTES, France – September 23, 2025, 10:30 p.m. CET – OSE Immunotherapeutics SA(ISIN: FR0012127173; Mnemo: OSE) acknowledges the decision rendered on September 23, 2025, by the Nantes Commercial Court rejecting its claims in the proceedings concerning the declaration of concerted action by a group of minority shareholders.In the best interests of the Company, in order to focus on the execution of its...
Nasdaq GlobeNewswire
23/09/2025

Endo Expands ADRENALIN® Ready-to-Use Premixed Bag Line with Three New…

The 5 mg/250 mL and 10 mg/250 mL concentrations align with the American Society of Health-System Pharmacists (ASHP) Standardize 4 Safety Initiative, supporting efforts to reduce medication errors and enhance patient safety. The 5 mg/250 mL and 10 mg/250 mL concentrations align with the American Society of Health-System Pharmacists (ASHP)Standardize 4 Safety Initiative, supporting efforts to reduce medication errors and enhance patient safety. ADRENALIN ®is the first FDA-approved,...
PR Newswire
23/09/2025

Nyxoah Provides an Update on Expanded Middle East Presence

Nyxoah Provides an Update on Expanded Middle East PresenceNew Centers in Dubai, Kuwait, and Abu Dhabi Following First Genio® Implant in the Region Earlier in 2025Mont-Saint-Guibert, Belgium – September 23, 2025, 10:10pm CET / 4:10pm ET – Nyxoah SA (Euronext Brussels/Nasdaq: NYXH), a medical technology company that develops breakthrough treatment alternatives for Obstructive Sleep Apnea (OSA), today announced the continued expansion of its commercial footprint in the Middle East,...
Nasdaq GlobeNewswire
23/09/2025

LifeSpan Portfolio Company Remedium Signs Landmark Deal with Eli Lilly

"We congratulate Frank and the Remedium team on this important milestone with Lilly," said Andrew Worden, Founding Partner at Lifespan Vision Ventures. "It is a powerful validation of their platform and is an important step toward developing interventions that extend healthspan. We're excited to support Remedium as they scale their platform and translate it into therapies that can benefit millions of patients." "We congratulate Frank and the Remedium team on this…
PR Newswire
23/09/2025

IPSEN - Buy-back programme - Art 5 of MAR - Week 38 - 2025

Aggregated presentation by day and by marketStatement of transactions in own shares from September 15th to September 19th 2025 Name of the issueIdentity code of the issuer(Legal Entity Identifier) Day of the transactionIdentity code of the financial instrument Total daily volume (in number of shares)Daily weighted average purchase price of the sharesMarket (MIC Code)IPSEN549300M6SGDPB4Z94P1115/09/2025FR0010259150300...
Nasdaq GlobeNewswire
23/09/2025

LUMIBIRD : H1 2025 RESULTS SHOW STRONG GROWTH IN BOTH DIVISIONS

Group EBITDA at €20.2 million (+85%), representing 18.9% of revenue Medical Division: EBITDA of €12.1 million, representing 21.8% of revenue (vs. 17.6% in H1 2024) Photonics Division: EBITDA of €8.1 million, representing 15.8% of revenue (vs. 4.3% in H1 2024) The Lumibird Group, European leader in laser technologies, posted significantly improved…
Actusnews Wire
23/09/2025

With 8.2% CAGR Chronic Total Occlusion Market Size Surges US$ 4.22 billion by…

Built for Complexity: CTO Solutions Gaining Momentum Built for Complexity: CTO Solutions Gaining Momentum Chronic Total Occlusion Market to Surge with Demand for Advanced, High-Precision Interventional DevicesValued at US$2.44 billionin 2024. Themarketis projected to reach US$4.22 billionby 2031, registering a strongCAGR of 8.2% (2025–2031). This growth is driven by Increasing Aging Population, growing Prevalence of Cardiovascular Diseases, and emerging healthcare...
PR Newswire
23/09/2025

Kidney Dialysis Equipment Market is projected to reach US$27.04 billion by 2031…

Kidney Dialysis Equipment Market Set to Soar with Demand for Personalized, Patient-Centric Care within the dialysis equipment landscape Kidney Dialysis Equipment Market Set to Soar with Demand for Personalized, Patient-Centric Care within the dialysis equipment landscape Valued at US$17.23 billionin 2024. Themarketis projected to reach US$27.04 billionby 2031, registering a strongCAGR of 6.8% (2025–2031). This growth is driven by rising cases of chronic kidney disease and...
PR Newswire
23/09/2025

With 5% CAGR Paracetamol Market is expected to grow US$15.03 billion by 2031…

Check valuable insights in the Paracetamol Market report. You can easily get a sample PDF of the report -https://www.theinsightpartners.com/sample/TIPRE00038952 Check valuable insights in the Paracetamol Market report. You can easily get a sample PDF of the report -https://www.theinsightpartners.com/sample/TIPRE00038952 Paracetamol Market Set to Soar with Demand for Over-The-Counter (OTC) AnalgesicsValued at US$10.75 billionin 2024. Themarketis projected to reach US$15...
PR Newswire
23/09/2025

LILYSILK Unveils Winter 2025 Collection "Framed Beauty," Celebrating Strength…

With clean lines, tailored silhouettes, and balanced proportions, the collection blends softness and strength in a refined expression of modern femininity. While materials such as silk-wool and cashmere-wool remain central, it is the sculptural design and architectural sensibility that truly set this collection apart. With clean lines, tailored silhouettes, and balanced proportions, the collection blends softness and strength in a refined expression of modern femininity. While materials such…
PR Newswire
23/09/2025

Major Shareholder Announcement

Company Announcement Major shareholder announcement for Genmab A/S COPENHAGEN, Denmark; September 23, 2025 –Genmab A/S(Nasdaq: GMAB) announces under reference to Section 30 of the Danish Capital Markets Act that Orbis Investment Management Limited has informed us that, as of September 19, 2025, Orbis Investment Management Limited through shares and ADRs, representing shares, controlled the voting rights to 3,230,732 shares in Genmab A/S, which amounts to 5.03% of the share...
Nasdaq GlobeNewswire
23/09/2025

VAPORESSO's Decade of Innovation: Elevating Vaping Aesthetics with the XROS 5…

Innovation as the Accelerator of a Decade's Excellence Innovation as the Accelerator of a Decade's Excellence Celebrating its 10th anniversary, VAPOREESO pays tribute to the legends of speed on the track by infusing its innovative spirit into the design of theInno-Speed Editions. These special editions incorporate a variety of racing-inspired design elements, combined with carbon fiber panels, supercar hand-drawn illustration, and a custom dashboard-style UI. Exclusively packaged as...
PR Newswire
23/09/2025

LabConnect Partners with The Bracken Group to Expand Radiopharmaceutical Support…

The Bracken Group (Bracken) is widely recognized for its scientific leadership and strategic expertise in the radiopharma space. Known for key opinion leadership and a broad scientific approach, Bracken brings unmatched insights across development, regulatory, and commercialization efforts. The Bracken Group (Bracken) is widely recognized for its scientific leadership and strategic expertise in the radiopharma space. Known for key opinion leadership and a broad scientific approach, Bracken...
PR Newswire
23/09/2025

Pictor Secures Funding to Accelerate U.S. Expansion through Partner-Informed…

Pictor will deploy the new capital to further fuel its market expansion and commercial operations across the United States following the successful establishment of its Carlsbad headquarters. The funding will also support and advance partner-driven product development initiatives, including expansion of the company's patented PictArray™ across both human and animal health applications. Pictor will deploy the new capital to further fuel its market expansion and commercial operations acrossthe...
PR Newswire
23/09/2025

Myriad Genetics and SOPHiA GENETICS to Develop an Innovative Companion…

SOPHiA GENETICS and Myriad will initially focus on the liquid biopsy application, MSK-ACCESS® powered with SOPHiA DDM™. Developed in collaboration with Memorial Sloan Kettering Cancer Center, MSK-ACCESS® powered with SOPHiA DDM™ is an innovative liquid biopsy test that detects actionable genomic alterations from a single blood draw using proprietary, state-of-the-art algorithms which analyze circulating tumor DNA (ctDNA). By developing the application into a CDx, more patients can gain access to…
PR Newswire
23/09/2025

KATE SPADE NEW YORK'S NEW CAMPAIGN, "SPARK SOMETHING BEAUTIFUL," BRINGS BACK…

Set against the bustling backdrop of New York City, we follow our protagonist as she navigates on her own...until she approaches a street crossing. As her friends join her, their togetherness sparks a transformation of the crossing into a celebration of how even a small moment of connection can spark something beautiful. Set against the bustling backdrop ofNew York City, we follow our protagonist as she navigates on her own...until she approaches a street crossing. As her friends join...
PR Newswire
23/09/2025
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