Calendar

Week of Oct 27, 2025

Oct 30, 2025approval292d agoTYRUKO (NATALIZUMAB-SZTN) — FDA approvalnatalizumab biosimilar

Sponsor: SANDOZ INC. Form: INJECTABLE. Route: INJECTION

Oct 30, 2025approval292d agoVIMIZIM (ELOSULFASE ALFA) — FDA approvalBIOMARIN PHARMACEUTICAL INC

Sponsor: BIOMARIN PHARM. Form: INJECTABLE. Route: INJECTION

Oct 30, 2025approval292d agoHALDOL (HALOPERIDOL DECANOATE) — FDA approvalJanssen Therapeutics

Sponsor: JANSSEN PHARMS. Form: INJECTABLE. Route: INJECTION

Oct 30, 2025approval292d agoAXITINIB — FDA approvalaxitinib SR

Sponsor: APOTEX. Form: TABLET. Route: ORAL

Oct 30, 2025approval292d agoEVEROLIMUS — FDA approvalPostsurgical Therapeutics Inc

Sponsor: NOVUGEN. Form: TABLET. Route: ORAL

Oct 31, 2025approval291d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL

Oct 31, 2025approval291d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

Oct 31, 2025approval291d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

Oct 31, 2025approval291d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

Oct 31, 2025approval291d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

Nov 3, 2025approval288d agoSTELARA (USTEKINUMAB) — FDA approvalJOHNSON & JOHNSON

Sponsor: CENTOCOR ORTHO BIOTECH INC. Form: INJECTABLE. Route: INJECTION

Nov 3, 2025approval

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