News
The most recent news and industry headlines are presented in this section. Our dedicated team closely observes the pharmaceutical industry and keeps you informed of the most recent developments around the Europe.
Clinilabs Completes Routine FDA Inspection with No Observations
Wednesday, April 15, 2026Clinilabs LLC a global fullservice contract research organisation CRO focused on the development of medicines and medical devices for the central nervous system has successfully completed a routine inspection by the US Food and Drug Administration FD...
Dyve Biosciences and Moffitt Cancer Center Report Promising Results for Novel Topical Therapy Targeting Tumour Acidity
Wednesday, April 15, 2026Dyve Biosciences in collaboration with Moffitt Cancer Center has reported encouraging results for an investigational topical therapy designed to target tumour acidity across the body
U.S. FDA Grants RMAT Designation to GS-100 for NGLY1 Deficiency
Wednesday, April 15, 2026Grace Science LLC has received Regenerative Medicine Advanced Therapy RMAT designation from the US Food and Drug Administration FDA for GS an investigational gene therapy for the treatment of NGLY deficiency
EU Records Significant Pharma Export Uptick in 2025 Amid Competitiveness Concerns
Wednesday, April 15, 2026The European Union achieved a record trade surplus of bn in pharmaceuticals for driven by a yearonyear increase in export value though analysts warn of potential frontloading ahead of challenges
Septerna Begins Phase 1 Trial of Oral SEP-479 for Hypoparathyroidism
Tuesday, April 14, 2026Septerna Inc has started a Phase clinical trial of SEP an oral small molecule designed to treat hypoparathyroidism The company has dosed the first participants in the study
OXB Introduces Fast-Track Offering to Speed Up Viral Vector Development and Manufacture
Tuesday, April 14, 2026OXB has launched a new fasttrack development and manufacturing service to support programmes using adenoassociated viral AAV and lentiviral LV vectors The offering is designed to provide a quicker route to GMP manufacturing for eligible biotech clien...
Kymera Therapeutics Receives FDA Fast Track Status for KT-621 in Asthma Treatment
Tuesday, April 14, 2026Kymera Therapeutics Inc has received Fast Track designation from the US Food and Drug Administration for KT an oral STAT degrader developed to treat moderate to severe eosinophilic asthma
ANI Pharmaceuticals Launches Carbamazepine Extended-Release Capsules
Tuesday, April 14, 2026ANI Pharmaceuticals Inc has announced the launch of Carbamazepine ExtendedRelease Capsules in strengths of mg mg and mg The product is a generic version of Carbatrol
Axplora Announces Expansion of R&D and Laboratory Hub at Farmabios Site in Italy
Tuesday, April 14, 2026Axplora has announced plans to construct a new sqm RD and laboratory facility at its Farmabios site in Gropello Cairoli Italy to bolster manufacturing and innovation capabilities in the European pharma sector
Drug Manufacturing Deals Shift to Europe Amid US Decline and Pharma Tariffs
Monday, April 13, 2026Europe has outpaced the US by more than threefold in contract manufacturing deals for FDAapproved drugs in marking a significant shift in the global pharma manufacturing landscape
