News about "pharmaceutical regulatory approval"

Sanofi Secures Japan Approval for Subcutaneous Formulation of Sarclisa

Sanofi Secures Japan Approval for Subcutaneous Formulation of Sarclisa

Sanofi’s Sarclisa subcutaneous formulation has been approved in Japan for patients with multiple myeloma. The approval is supported by the Phase 3 IRAKLIA study and marks the second global approval after the EU.

Pharmaceutical Regulatory Approval | 22/06/2026 | By News Bureau

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

Lupin Gets US FDA Tentative Approval for Pitolisant Tablets

US FDA grants tentative approval to Lupin’s Pitolisant Tablets (4.45 mg, 17.8 mg), bioequivalent to Wakix, for approved indications.

Pharmaceutical Regulatory Approval | 25/03/2026 | By News Bureau 116


 

 

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