Leveraging the power of Microsoft Cloud for health authority queries to create streamlined, efficient processes.

The Saudi Food and Drug Authority (SFDA) has suspended the registration of a European pharmaceutical factory following the discovery of serious violations of Good Manufacturing Practices (GMP) during ...

Many pharmaceutical products made in Europe will face a 15 percent tariff, pinching manufacturers and potentially leading to ...

CDSCO revises guidance for issuing No Objection Certificates (NOCs) for new drug formulations intended for export. The ...

A regulatory filing seeking approval for a subcutaneous (SC) maintenance dosing version of Leqembi is currently under the FDA’s review. A final decision is expected by Aug. 31, 2025.

CHENNAI: Swiss-pharma major Novartis AG said early this week that its pediatric malaria treatment, Coartem Baby, received regulatory approval from Swissmedic, S ...

The decision came after SFDA inspectors identified fundamental lapses in the factory’s manufacturing procedures and internal quality systems, posing a direct risk to the safety of pharmaceutical produ ...