🇺🇸 FDA Updates
- CAVHANZA (nilotinib) approved (June 2, 2026) for Ph+ chronic myeloid leukemia with improved formulation allowing use alongside PPIs/H2 blockers without restrictions.
- Ensitrelvir (Xocova) approved (May 29, 2026) as the first oral option for COVID-19 post-exposure prophylaxis.
- Zaynich (cefepime + zidebactam) approved (May 29, 2026) for complicated urinary tract infections.
- Pivekimab sunirine approved (May 27, 2026) for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare blood cancer.
- Bulevirtide (Hepcludex) granted accelerated approval (May 22, 2026) for chronic hepatitis delta virus infection.
🇪🇺 EMA Updates
- COVID-19 vaccine update: EMA’s Emergency Task Force recommends vaccines be reformulated to target the XFG Omicron subvariant for the 2026/27 campaign.
- CHMP recommendations: Eight new medicines recommended for approval, including therapies for pulmonary fibrosis and expanded indications for 13 existing drugs.
- Seasonal flu vaccine composition: EU recommendations for 2026/27 influenza strains published (May 29, 2026).
🇮🇳 CDSCO Updates
- Revised sampling guidelines (May 26, 2026): Drug inspectors must now provide expanded details (product type, dosage form, route, manufacturer, batch, NSQ results) in digital monthly reports to improve traceability of substandard and spurious drugs.
- Pregabalin restriction (May 13, 2026): Added to Schedule H1, removing OTC availability due to rising abuse concerns.
- Digital Drugs Regulatory System RFP: Invitation for bids to design and implement a Digital Drugs Regulatory System (DDRS), deadline June 11, 2026.
📅 Compliance Watchlist
- FDA upcoming decisions (June 2026):
- Ensitrelvir prophylaxis (COVID-19) – June 16
- Tebipenem HBr (complicated UTI) – June 18
- Cytisinicline (smoking cessation) – June 20
- Oxylanthanum carbonate (CKD dialysis) – June 29
⚠️ Risks & Considerations
- Hidden ingredients in supplements flagged by FDA (e.g., Sensual Miracle Honey, Big Dick Energy!) pose serious drug interaction risks. “)
- Pregabalin misuse in India highlights growing concerns about prescription drug abuse.
- COVID-19 vaccine updates in EU may affect supply chains and require rapid manufacturer compliance.
Reference drug.com