Regulatory Approvals

Anktiva operates through a novel mechanism by binding to the interleukin-15 (IL-15) receptor, which triggers the proliferation and activation of natural killer cells, CD4+ cells, CD8+ cells, and memory T cells.

Adults with obesity and a BMI of 30 kg/m² or higher can now use Wegovy at a 7.2mg dose level, which requires three consecutive 2.4mg doses instead of a single injection.

The U.S. Food and Drug Administration (FDA) recently approves an updated label for UNLOXCYT based on long-term follow-up data from the pivotal CK-301-101 clinical trial.

Inpefa is the first dual SGLT1 and SGLT2 inhibitor approved specifically for heart failure treatment.

The NMPA based its decision on compelling evidence from the TRIDENT-1 study, a pivotal Phase I/II clinical trial that demonstrated the drug’s effectiveness over time.

This strategic shift addresses mounting concerns about regulatory compliance and workforce development in the country’s healthcare sector.

The Pharmacy and Poisons Board has approved both the 300 mg tablet and 464 mg injectable solution forms of Lenacapavir for use as pre-exposure prophylaxis (PrEP).

NAFDAC’s decision came after assessing outcomes from these surgeries, which used the Toumai system manufactured by Shanghai MicroPort MedBot.

With this latest authorisation, individuals now have access to a long-acting option for prevention rather than daily pill-based regimens.

The therapy is indicated for patients aged 12 years and older with severe asthma characterized by an eosinophilic phenotype.