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News about Drug Discovery & Development
NanoMosaic Secures FDA AMT Designation for Nanoneedle Technology in AAV Gene Therapy Manufacturing
FDA’s CBER grants Advanced Manufacturing Technology designation to NanoMosaic’s Nanoneedle platform, enhancing regulatory engagement and streamlining quality control in AAV gene therapy production.
Drug Discovery & Development | 30/01/2026 | By News Bureau | 204
Grail Submits Final PMA Module to FDA for Galleri Multi-Cancer Early Detection Test
Grail files the final Premarket Approval module with the FDA for its Breakthrough Device-designated Galleri test, supported by data from over 25,000 participants in PATHFINDER 2 and the NHS-Galleri trial.
Drug Discovery & Development | 30/01/2026 | By News Bureau | 546
European Commission Expands Bracco's Vueway Approval to Infants and Neonates
Bracco Imaging secures EU approval to extend Vueway’s use to infants and neonates, enhancing safe and effective MRI diagnostics for young patients.
Drug Discovery & Development | 28/01/2026 | By News Bureau | 181
European Commission Expands GSK's RSV Vaccine Arexvy to Adults Aged 18 and Above
GSK’s RSV vaccine Arexvy receives European approval for adults aged 18 plus, marking a major expansion in protection against RSV-related respiratory illness across the region.
Drug Discovery & Development | 28/01/2026 | By News Bureau | 163
FDA Clears Expanded Access Programme for StemCyte's RegeneCyte Therapy in Long covid Patients
The FDA has approved an Expanded Access programme for StemCyte’s RegeneCyte, enabling eligible Long covid patients to access the cord blood-based therapy amid ongoing clinical trials.
Drug Discovery & Development | 27/01/2026 | By News Bureau | 329
ACON Launches FDA-Cleared Flowflex Plus 4-in-1 Home Test for RSV, Flu and Covid, Including Infants
Acon Laboratories has launched the first FDA-cleared 4-in-1 home test detecting RSV, Flu A, Flu B and Covid-19, approved for adults and children as young as six months.
Drug Discovery & Development | 27/01/2026 | By News Bureau | 353
BD has launched Research Cloud 7.0 globally, introducing the AI-driven Horizon Panel Maker to automate panel design, streamline workflows and enhance data quality in immunology and cancer research.
Drug Discovery & Development | 27/01/2026 | By News Bureau | 383
AGC Biologics’ Milan Cell and Gene Centre of Excellence will support the commercial rollout of Waskyra following US FDA and EU approvals, strengthening treatment options for patients with Wiskott-Aldrich syndrome.
Drug Discovery & Development | 22/01/2026 | By News Bureau | 231
CDSCO Flags 167 Drug Samples as Substandard, Seven Found Spurious
India’s drug regulator has identified 167 medicine samples that failed quality tests and classified seven additional samples as spurious during routine surveillance conducted in December. The findings were released as part of the Central Drugs Standard Control Organisation’s (CDSCO) monthly drug alert.
Drug Discovery & Development | 22/01/2026 | By Darshana | 261
China's NMPA Accepts Akeso's Gumukimab sNDa for Ankylosing Spondylitis
China’s NMPA gives approval to Akeso’s gumokimab for the treatment of active ankylosing spondylitis, supported by Phase III data showing significant symptom relief and functional improvement.
Drug Discovery & Development | 20/01/2026 | By News Bureau | 378
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