COMMUNIQUÉS West-GlobeNewswire

Ultragenyx Announces FDA Clearance of Investigational New Drug (IND) Application for UX016, a Sialic Acid Prodrug for the Treatment of GNE Myopathy
30/03/2026
Program to be externally funded by a venture philanthropy agreement through clinical proof-of-concept, including the Phase 1/2 study planned to begin in the second half of 2026 NOVATO, Calif., March 30, 2026 (GLOBE [...]
SeaStar Medical Showcases New Positive Data from the QUELIMMUNE SAVE Registry and an Analysis of the Unique Immunomodulatory Mechanism of the SCD Therapy at AKI & CRRT 2026
30/03/2026
Results from pediatric patients in the SAVE Registry shows no device-related adverse events or immunosuppression and continued strong survival data In vitro analysis of the SeaStar Medical SCD indicates modulation of [...]
SCIENTURE Reports Year End 2025 Financial Results and Provides Business Update
30/03/2026
Reports Significant Revenue Growth and Gross Margin Expansion in 2025 COMMACK, NY, March 30, 2026 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. (NASDAQ: SCNX) (“Scienture”), a holding company for existing and planned [...]
Vor Bio Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
30/03/2026
First patient dosed in UPSTREAM SjD, a global Phase 3 clinical trial assessing telitacicept in primary Sjögren’s disease $75 million private placement strengthens balance sheet and supports telitacicept global clinical [...]
Aprea Therapeutics Announces Oversubscribed $30 Million Private Placement
30/03/2026
Financing led by Soleus Capital with participation from Vestal Point Capital, Squadron Capital Management and additional new and existing investors DOYLESTOWN, Pa., March 30, 2026 (GLOBE NEWSWIRE) -- Aprea Therapeutics [...]
Teva Gains Biosimilar Momentum with U.S. FDA Approval of PONLIMSI™ (denosumab-adet) and Dual Filing Acceptance for Biosimilar Candidate to Xolair® (omalizumab)
30/03/2026
Teva’s biosimilar, PONLIMSI™, is now FDA-approved across all indications of the reference product, Prolia ® (denosumab), to treat a variety of debilitating bone conditions. Teva’s proposed biosimilar candidate to Xolair [...]
Evaxion to present novel AI-based polio vaccine design concepts at the World Vaccine Congress
30/03/2026
Using its pioneering AI-platform, AI-Immunology™, Evaxion has, in collaboration with the Gates Foundation, developed novel design concepts for polio vaccines potentially superior to those currently used The AI- [...]
Teva gagne du terrain dans le domaine des médicaments biosimilaires grâce à l’approbation accordée par la FDA pour PONLIMSI™ (dénosumab-adet) et à l’acceptation d’un double dossier pour un candidat biosimilaire à Xolair® (omalizumab)
30/03/2026
Le médicament biosimilaire de Teva, PONLIMSI™, est désormais approuvé par la FDA pour toutes les indications du produit de référence, Prolia ® (dénosumab), dans le cadre du traitement de diverses pathologies osseuses [...]
Palvella Therapeutics Announces Scientific Publication in Journal of Vascular Anomalies Highlighting the Infiltrative Growth and Therapeutic Challenges of Microcystic Lymphatic Malformations
30/03/2026
Review delineates differences in clinical strategies between microcystic and macrocystic lymphatic malformations to guide disease-specific clinical trial design and treatment approaches Manuscript emphasizes the [...]
Elevar Therapeutics Announces FDA Acceptance for Review of New Drug Application for Lirafugratinib as Second-line Cholangiocarcinoma Treatment
30/03/2026
With Priority Review designation, FDA set a Sept. 27 PDUFA date for approval decision Lirafugratinib achieved a 46.5% ORR, in CCA patients with FGFR2 fusion and rearrangement Fort Lee, N.J., March 30, 2026 (GLOBE [...]
Anavex Life Sciences Provides Comprehensive Regulatory Update
30/03/2026
Dialogue continues with European Medicines Agency (EMA) to advance the development program of oral blarcamesine in early Alzheimer’s disease Additional data submitted to the U.S. FDA with the objective to discuss [...]
Marvel Biosciences Secures Alberta Innovates Funding to Support the Phase I Testing of MB-204
30/03/2026
CALGARY, Alberta, March 30, 2026 (GLOBE NEWSWIRE) -- Marvel Biosciences Corp. (TSXV: MRVL | OTC: MBCOF ), and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively “Marvel” or the “Company” ), a drug [...]
FDA Approves New High Dose Regimen of SPINRAZA® (nusinersen) for Spinal Muscular Atrophy
30/03/2026
The approval was anchored on data from the pivotal DEVOTE study that investigated the efficacy and safety of the High Dose Regimen of SPINRAZA in treatment-naïve and previously treated SPINRAZA patients High Dose [...]
Bicara Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update
30/03/2026
Selected 1500mg weekly of ficerafusp alfa as the optimal dose and initiated Phase 3 of the FORTIFI-HN01 pivotal trial; interim analysis expected mid-2027 Announced development of a less frequent loading and every-three- [...]
SEED Therapeutics Announces Poster Presentation at AACR Annual Meeting 2026
30/03/2026
KING OF PRUSSIA, Pa., March 30, 2026 (GLOBE NEWSWIRE) -- SEED Therapeutics, Inc. (“SEED”) , a clinical-stage biotechnology company specializing in molecular glue degraders, today announced that it will have a poster [...]
BeyondSpring Announces Plinabulin and ADC Combination Poster Presentation at AACR Annual Meeting 2026
30/03/2026
FLORHAM PARK, N.J., March 30, 2026 (GLOBE NEWSWIRE) -- BeyondSpring Inc. (NASDAQ: BYSI) (“BeyondSpring” or the “Company”), a clinical-stage company developing transformative therapies for the treatment of cancer and [...]
Medicus Pharma Reports KOL Validation of SkinJect Phase 2 Data of 80% Overall Response Rate
30/03/2026
Dr. Babar Rao highlights clinically meaningful outcomes with majority of lesions potentially avoiding immediate surgery in non-melanoma Skin Cancer PHILADELPHIA, March 30, 2026 (GLOBE NEWSWIRE) -- Medicus Pharma Ltd. ( [...]
BioRestorative Therapies Reports Positive Phase 2 Blinded Data for BRTX-100 Demonstrating Meaningful Improvements in Pain and Function in Chronic Lumbar Disc Disease
30/03/2026
Data showed 50% or more of patients reporting >50% improvement in key pain and function scales No adverse events related to dose-limiting toxicities associated with hypoxic-cultured mesenchymal stem cells Presented [...]
Damora Therapeutics Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
30/03/2026
BOSTON, March 30, 2026 (GLOBE NEWSWIRE) -- Damora Therapeutics, Inc. (NASDAQ: DMRA) (“Damora”), a biotechnology company working to fundamentally redefine care for patients with blood disorders, today announced that it [...]

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