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FDA accepts Eisai's subcutaneous Leqembi filing, sets January 25 decision date

Fierce Pharma

About a month after Eisai initiated a rolling FDA application for its subcutaneous form of Leqembi, the U.S. The FDA assigned the subcutaneous Leqembi application a Prescription Drug User Fee Act decision date of January 25, 2025. agency has accepted the filing. |

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New Reimbursement Opportunities for Digital Mental Health Treatment in 2025: CMS’ Final Rule

Nixon Gwilt Law

CMS issued its 2025 Medicare Physician Fee Schedule (the “2025 MPFS” or “Final Rule”) on November 1, 2024. The Final 2025 MPFS contains some modifications and clarifications to several elements of the original proposal released in July 2024 (the “Proposed Rule”), which we discussed in this earlier post.

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New Reimbursement Opportunities for Digital Mental Health Treatment in 2025: CMS’ Final Rule

Nixon Gwilt Law

CMS issued its 2025 Medicare Physician Fee Schedule (the “2025 MPFS” or “Final Rule”) on November 1, 2024. The Final 2025 MPFS contains some modifications and clarifications to several elements of the original proposal released in July 2024 (the “Proposed Rule”), which we discussed in this earlier post.

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FDA Accepts sNDA of Roflumilast Foam for Scalp and Body Psoriasis

Pharmacy Times

The FDA assigned a Prescription Drug User Fee Act action date of May 22, 2025.

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FDA Accepts Biologics License Application For Nivolumab Plus Ipilimumab to Treat Hepatocellular Carcinoma

Pharmacy Times

The FDA assigned the combination a Prescription Drug User Fee Act goal date of April 21, 2025.

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FDA Accepts Resubmitted NDA for AXS-07 for Acute Treatment of Migraine

Pharmacy Times

The FDA assigned a Prescription Drug User Fee Action date is January 31, 2025.

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FDA Accepts NDA and Priority Review Application for Vimseltinib in Tenosynovial Giant Cell Tumors

Pharmacy Times

Vimseltinib (Deciphera Pharmaceuticals) has a Prescription Drug User Fee Act goal date of February 17, 2025.