Sarepta Gains Complete Approval and Expanded Label for DMD Gene Therapy
Sarepta Gains Complete Approval and Expanded Label for DMD Gene Therapy Sarepta The FDA announced on Thursday that Sarepta Therapeutics’…
Regulatory Pharma Blogs
Sarepta Gains Complete Approval and Expanded Label for DMD Gene Therapy Sarepta The FDA announced on Thursday that Sarepta Therapeutics’…
Spikevax Modernas latest COVID vaccine outperforms the current shot in a crucial efficacy trial involving adults. Spikevax Moderna latest COVID…
Clarios SpiroSphere® with wireless ECG- FDA clears, simplifying clinical trial data collection. Clarios SpiroSphere The FDA has granted 510(k) clearance…
DSCSA (Drug Supply Chain Security Act): FDA extends on 24 DSCSA tracking rules for small dispensers by two years and…
Medical device equipment: The report suggests strategies to enhance accessibility and cost-effectiveness of crucial medical device equipment. Medical device equipment…
GAMP 5: Concept of GAMP 5 in Pharmaceuticals GAMP-5 Good Automated Manufacturing Practice consists of guidelines aimed at both users…
Cefepime Orchid Pharma has been granted approval by the Drug Controller General of India (DCGI) for its Cefepime and Enmetazobactam…
Influence of TMR highlights the significance of being agile and adaptable when addressing regulatory changes. Influence of TMR highlights the…
The Indian pharmaceutical industry adopts eco-friendly measures to reduce plastic usage and transition to renewable energy sources. Indian pharmaceutical industry…
Device surveillance the European Unions Medical Device Coordination Group (MDCG) has released revised guidance on device surveillance. Device surveillance The…