News and Press Releases
ProteoNic 2G UNic Technology Licensed by Ginkgo Bioworks for BARDA-Supported Consortium Advancing Monoclonal Antibody Manufacturing for Anti-Filovirus Therapies
11 December 2025 -- Leiden, The Netherlands -- ProteoNic BV, a leading provider of premium vector technology for biopharmaceutical and viral vector production, today announced that its proprietary 2G UNic® technology...
Category: BioManufacturing, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: December 11, 2025
Valneva Reports Positive Results for Phase 1 Trial of Second-Generation Zika Vaccine Candidate
Immune response successfully improved with second generation vaccine candidate4 November 2025 -- Saint-Herblain, France -- Valneva SE, a specialty vaccine company, today announced positive results of its Phase 1 clinical...
Category: BioManufacturing, Biotechnology, Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: November 4, 2025
SOM Biotech secures clear registrational path for SOM3355 in Huntington’s disease after FDA End‑of‑Phase 2 Meeting
20 October 2025 -- Barcelona, Spain -- SOM Biotech, a clinical-stage company dedicated to the discovery and development of innovative therapies for rare central nervous system disorders, announces today that it...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: October 20, 2025
Pharming Group announces U.S. FDA acceptance and Priority Review of supplemental New Drug Application forleniolisib in children with APDS aged 4 to 11 years
If approved, leniolisib will be first and only treatment indicated for children with activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS), a rare primary immunodeficiency Decision based on positive data from...
Category: Biotechnology, Drug Discovery, Other, Pharmaceutical
Posted: October 1, 2025
Pharming Group N.V. Vondellaan 47 2332 AA Leiden The Netherlands
Innoviva Specialty Therapeutics Receives FDA New Drug Application Acceptance for Zoliflodacin, a First-in-Class Oral Antibiotic for Uncomplicated Gonorrhea in Adults
In laboratory studies, zoliflodacin has been shown to be active against Neisseria gonorrhoeae including multidrug-resistant strains If approved, zoliflodacin could become the first new antibiotic treatment for gonorrhea in decades. 10 June...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: June 10, 2025
University of Oxford and ReciBioPharm expand strategic collaboration in fight against malaria
Expands the collaboration to manufacture two malaria vaccine candidates (R78C and RH5.1) for Phase 1/2 clinical trials Delivers the sixth malaria vaccine candidate for the University of Oxford Provides drug...
Category: Biotechnology, Clinical Trials, Logistics, Manufacturing and Packing, Pharmaceutical
Posted: June 9, 2025
Liverpool City Region set to become global powerhouse in new front for fighting disease and driving wellbeing
23 April 2025 -- Liverpool, UK -- Liverpool City Region is set to become a global powerhouse in a new front to tackle deadly diseases and improve wellbeing. More than...
Category: Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: April 23, 2025
US FDA Grants Qualified Infectious Disease Product Designation to Venus Remedies’ VRP-034, a Novel Polymyxin B Formulation
VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate, uniquely developed to mitigate the nephrotoxic effects associated with conventional polymyxin B (PMB) therapy Key preclinical findings for...
Category: Biotechnology, Clinical Trials, Drug Delivery, Other, Pharmaceutical
Posted: April 17, 2025
51-52, Industrial Area Phase-1, Panchkula, Haryana, 134113
Tiziana Life Sciences Files Investigational New Drug Application with FDA for ALS Phase 2 Clinical Trial
4 March 2025 -- New York, US -- Tiziana Life Sciences, Ltd, a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: March 4, 2025
Tiziana Life Sciences 14/15 Conduit Street London W1S 2XJ United Kingdom
Boehringer’s nerandomilast meets primary endpoint in Phase III study FIBRONEER-ILD, in progressive pulmonary fibrosis
Topline data from FIBRONEER™-ILD show that the investigational compound nerandomilast met its primary endpoint, which was the absolute change from baseline in forced vital capacity [mL] at week 52 versus...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: February 10, 2025
HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC
Indication expands to include treatment-naïve patients The 2021 conditional approval in previously treated patients converted to full approval. 14 January 2025 -- Hong Kong, Shanghai, and New Jersey, US --...
Category: Clinical Trials, Drug Discovery, Other, Pharmaceutical
Posted: January 14, 2025
PTC Therapeutics Announces FDA Acceptance for Filing of NDA for Sepiapterin for the Treatment of Pediatric and Adult Phenylketonuria Patients
1 October 2024 -- New Jersey, US -- PTC Therapeutics, Inc. (NASDAQ: PTCT) announced today the FDA has accepted for filing the New Drug Application (NDA) of sepiapterin for the treatment of...
Category: Biotechnology, Drug Discovery, Pharmaceutical
Posted: October 1, 2024
PTC Therapeutics Inc. 100 Corporate Court South Plainfield, NJ 07080-2449
Innoviva Specialty Therapeutics Presents New Data on its Critical Care Antibiotic Therapy Portfolio at Infectious Disease Week (IDWeek) 2023
Oral presentation highlights new findings about the efficacy of XACDURO for the treatment of monomicrobial and polymicrobial Acinetobacter baumannii-calcoaceticus infections Researchers share global surveillance data on the in vitro activity of XERAVA (eravacycline) for injection on...
Category: Pharmaceutical
Posted: October 12, 2023
