The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Itovebi (Inavolisib( developed by Roche. The investigational therapy is intended for use in combination with palbociclib and fulvestrant for the treatment of adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or after completing adjuvant endocrine therapy.

As part of its comprehensive preparations for the Hajj season 2025, the Saudi Food and Drug Authority (SFDA) has intensified its proactive inspection efforts, conducting over 1,329 field visits to food, pharmaceutical, and medical device warehouses in the Makkah and Madinah regions. This aligns with the remarkable compliance rates observed in facilities storing food and medicine, a direct result of ongoing inspections and awareness-raising efforts that have reinforced their commitment to the requirements.

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to MIQNAF (Nafithromycin), developed by Wockhardt Bio AG. This designation is for its use in the treatment of adults with community-acquired bacterial pneumonia (CABP) and other mild to moderate infections such as acute bacterial exacerbations of chronic bronchitis (AECB), acute bacterial sinusitis, and pharyngitis/tonsillitis caused by susceptible pathogens.

As part of its early and comprehensive preparations for the Hajj season 2025, the Saudi Food and Drug Authority (SFDA) has launched a series of field inspection tours across key locations and facilities. The purpose is to assess the state of readiness of the inspection teams and to monitor the implementation of approved plans, with the aim of protecting the health and safety of pilgrims by ensuring the highest standards of food, drug, and medical product safety.

Treatment

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Novartis's medication Atrasentan (Vanrafia) , which is indicated to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk of disease progression.

A Selective Endothelin (A) Receptor Antagonist

The Saudi Food and Drug Authority (SFDA) has granted breakthrough designation to Sanofi's medication, Fitusiran (Qfitlia), which is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and adolescent patients aged 12 years and older with hemophilia A or B, with or without factor VIII or IX inhibitors.

The Saudi Food and Drug Authority (SFDA) has granted Breakthrough Designation to Eli Lilly’s medication, Imlunestrant (Inluriyo), for the treatment of advanced breast cancer. Imlunestrant is being developed as a monotherapy for the treatment of adult patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, estrogen receptor 1 (ESR1)-mutated advanced or metastatic breast cancer who have previously been treated with an endocrine based regimen.

Imlunestrant: A Selective Estrogen Receptor Inhibitor