.tb-field[data-toolset-blocks-field="09e3ae3ed9a5add2e67c07e7cc145f88"] { font-size: 13px;text-align: left;padding: 0px;margin: 0px; }  .tb-field[data-toolset-blocks-field="26b681d9a6f005d18c10ed511cda247b"] { font-size: 13px;text-align: left;padding: 0px;margin: 0px; }  .tb-grid,.tb-grid>.block-editor-inner-blocks>.block-editor-block-list__layout{display:grid;grid-row-gap:25px;grid-column-gap:25px}.tb-grid-item{background:#d38a03;padding:30px}.tb-grid-column{flex-wrap:wrap}.tb-grid-column>*{width:100%}.tb-grid-column.tb-grid-align-top{width:100%;display:flex;align-content:flex-start}.tb-grid-column.tb-grid-align-center{width:100%;display:flex;align-content:center}.tb-grid-column.tb-grid-align-bottom{width:100%;display:flex;align-content:flex-end} .wpv-view-output[data-toolset-views-view-editor="9b43713f5e44ea2ee722edd53959cdd9"] > .tb-grid-column:nth-of-type(3n + 1) { grid-column: 1 } .wpv-view-output[data-toolset-views-view-editor="9b43713f5e44ea2ee722edd53959cdd9"] > .tb-grid-column:nth-of-type(3n + 2) { grid-column: 2 } .wpv-view-output[data-toolset-views-view-editor="9b43713f5e44ea2ee722edd53959cdd9"] > .tb-grid-column:nth-of-type(3n + 3) { grid-column: 3 } .wpv-view-output[data-toolset-views-view-editor="9b43713f5e44ea2ee722edd53959cdd9"] .js-wpv-loop-wrapper > .tb-grid { grid-template-columns: minmax(0, 0.3333fr) minmax(0, 0.3333fr) minmax(0, 0.3333fr);grid-auto-flow: row } .wpv-pagination-nav-links[data-toolset-views-view-pagination-block="c35d9a7279448f10d949ebc7e457ae45"] { text-align: left;justify-content: flex-start; } .tb-grid,.tb-grid>.block-editor-inner-blocks>.block-editor-block-list__layout{display:grid;grid-row-gap:25px;grid-column-gap:25px}.tb-grid-item{background:#d38a03;padding:30px}.tb-grid-column{flex-wrap:wrap}.tb-grid-column>*{width:100%}.tb-grid-column.tb-grid-align-top{width:100%;display:flex;align-content:flex-start}.tb-grid-column.tb-grid-align-center{width:100%;display:flex;align-content:center}.tb-grid-column.tb-grid-align-bottom{width:100%;display:flex;align-content:flex-end} .wp-block-toolset-blocks-grid.tb-grid[data-toolset-blocks-grid="c3d01c7f0eaacb3eed155ab31795f301"] { background-color: rgba( 217, 217, 217, 0.13 );padding: 10px;margin-bottom: 15px;box-shadow: 5px 5px 10px 0 rgba( 0, 0, 0, 0.5 );border: 1px solid rgba( 215, 213, 213, 1 );grid-template-columns: minmax(0, 0.665fr) minmax(0, 0.335fr);grid-auto-flow: row } .wp-block-toolset-blocks-grid.tb-grid[data-toolset-blocks-grid="c3d01c7f0eaacb3eed155ab31795f301"] > .tb-grid-column:nth-of-type(2n + 1) { grid-column: 1 } .wp-block-toolset-blocks-grid.tb-grid[data-toolset-blocks-grid="c3d01c7f0eaacb3eed155ab31795f301"] > .tb-grid-column:nth-of-type(2n + 2) { grid-column: 2 } .tb-field[data-toolset-blocks-field="627e912eb953c8ed786ea0c7e10207ea"] { font-size: 14px;text-align: left;padding: 0px;margin: 0px; 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}     } 

News and Press Releases

FASENRA approved in US for hypereosinophilic syndrome

14 May 2026 -- Cambridge, UK -- AstraZeneca’s FASENRA (benralizumab) has been approved by the US FDA for the treatment of adult and pediatric patients aged 12 years and older with...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: May 14, 2026

CPHI Americas 2026 unveils keynote speakers tackling pharma’s toughest challenges

11 May 2026 -- Pennsylvania, US -- Informa Markets has announced its keynote speaker line-up for CPHI Americas 2026 (June 2–4), bringing together more than 80 industry thought leaders, including...

Category: Biotechnology, Other, Pharmaceutical
Posted: May 11, 2026

Informa

media@informa.com

5 Howick Place London SW1P 1WG UK

U.S. FDA Grants Breakthrough Device Designation to Laguna Diagnostics’ mRNA Gene Biomarker Test to Aid in Differentiation of Schizophrenia and Bipolar I Disorder

29 April 2026 -- California, US -- Laguna Diagnostics, LLC today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the company’s mRNA Gene...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 29, 2026

Laguna Diagnostics

info@lagunadiagnostics.com

U.S. FDA Grants Priority Review to sBLA for PADCEV + Keytruda as Perioperative Treatment for Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility

Submission based on statistically significant event-free and overall survival data from the Phase 3 EV-304 trial Building on the existing indication in cisplatin-ineligible muscle-invasive bladder cancer (MIBC), if approved, this...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: April 20, 2026

Astellas

2-5-1, Nihonbashi-Honcho, Chuo-Ku, Tokyo 103-8411, Japan

Recipharm expands manufacturing to meet demanding FDA requirements

Established a new, dedicated non-bacterial beta-lactam manufacturing facility in response to FDA guidance Secured a strategic partnership with an innovative biopharma company seeking rapid regulatory compliance Developed a scalable platform...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 26, 2026

Recipharm

Levicept Announces FDA Acceptance of IND Application for LEVI-04, a Potentially Disease-Modifying Treatment for Osteoarthritis

20 January 2026 -- Sandwich, UK -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis (OA), today announces the US Food and...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 20, 2026

Levicept

info@levicept.com

Innovation House Discovery Park Ramsgate Road Sandwich Kent CT13 9ND

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

FDA written feedback supports: a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 12, 2026

Relmada Therapeutics

info@relmada.com

2222 Ponce de Leon Blvd. Floor 3 Coral Gables, FL 33134

VectorY Therapeutics Receives FDA Fast Track Designation for VTx-002, a Firstin-Class Vectorized Antibody Targeting Underlying Disease Biology in ALS

Designation enables an enhanced development path for VTx-002 and underscores its disease-modifying potential in ALS, a universally fatal disease with no cure Milestone follows recent IND clearance and supports continued...

Category: BioManufacturing, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

VectorY Therapeutics

info@vectorytx.com

Science Park Matrix Innovation Center 408 1098 XH Amsterdam

AskBio Announces FDA Acceptance of Investigational New Drug (IND) Application for AB-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease (LOPD)

AB-1009 program advances to Phase 1/Phase 2; clinical trial initiated in the United States Therapy granted United States Food and Drug Administration (FDA) Fast Track and Orphan Drug designations Pompe...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 8, 2026

AskBio

info@askbio.com

20 T.W. Alexander Drive Suite, 110 Research Triangle Park, NC 27709

MapLight Therapeutics Receives Fast Track Designation for ML-007C-MA for Alzheimer’s Disease Psychosis

5 January 2026 -- California and Massachusetts, US -- MapLight Therapeutics, Inc today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ML-007C-MA, an...

Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 5, 2026

MapLight Therapeutics

info@maplightrx.com

800 Chesapeake Drive, Redwood City, California 9406

FDA Clears NUZ-001 for Entry into HEALEY ALS Platform Trial

FDA has completed their review of the Neurizon NUZ-001 regimen to the HEALEY ALS Platform Trial Master Protocol This marks the official entry of NUZ-001 as Regimen I in the...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 11, 2025

Neurizon Therapeutics

enquiries@neurizon.com

Level 4, 96-100 Albert Road South Melbourne, VIC 3205 Australia

Xlife Sciences AG Delivers Breakthrough in Early Alzheimer’s Detection, Unlocking Major Market Opportunity

1 December 2025 -- Zurich, Switzerland -- Xlife Sciences AG, together with saniva diagnostics GmbH, today announced a landmark achievement: NeuroMex is the world’s first certified and clinically validated medical device for...

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: December 1, 2025

Xlife Sciences

info@xlifesciences.ch

Talacker 35 8001 Zürich Switzerland

Annovis Announces FDA Meeting to Discuss Parkinson’s Disease Dementia Program; Reaffirms FDA Alignment on Pivotal Phase 3 Alzheimer’s Disease Study

18 November 2025 -- Pennsylvania, US -- Annovis Bio, Inc, a late-stage clinical drug platform company pioneering transformative therapies for neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease...

Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: November 18, 2025

Annovis

info@annovisbio.com

101 Lindenwood Drive, Suite 225 Malvern, PA 19355

ONWARD Medical Receives FDA 510(k) Clearance Expanding ARC-EX System Indication for Home Use

US FDA clearance now allows use of the ARC-EX System both in clinics and homes ARC-EX is the first and only FDA-cleared technology demonstrated to improve hand strength and sensation...

Category: Biotechnology, Other, Pharmaceutical
Posted: November 17, 2025

ONWARD Medical

investors@onwd.com

Schimmelt 2. 5656 AE, Eindhoven, the Netherlands

Acuitas Therapeutics to Showcase LNP Delivery Platform at Four Prestigious Conferences in November 2025

29 October 2025 -- British Columbia, Canada -- Acuitas Therapeutics, a global leader in lipid nanoparticle (LNP) delivery systems, today announced its participation in four upcoming conferences in November 2025....

Category: Biotechnology, Clinical Trials, Other, Pharmaceutical
Posted: November 11, 2025