Pricing & Access· August 18, 2026 · 16 min read
DTX401's August 23 PDUFA: Payers Face a Cornstarch-Replacement Gene Therapy
By Ran Chen#Gene Therapy#Rare Disease#Medicaid
Topic
FDA Approval
NDA, BLA, ANDA, 505(b)(2), label language, review packages, and approval-pathway interpretation.
Generics· August 18, 2026 · 14 min read
Generic Wakix Approved but Cannot Launch Until 2030: The Orange Book Fence
By Ran Chen#Orange Book#Generics#Generic Entry
Pricing & Access· August 18, 2026 · 18 min read
Ziihera's August 25 Gastric Decision: Bispecific vs Trastuzumab Biosimilars
By Ran Chen#Oncology#HER2#Biosimilars
Pricing & Access· August 17, 2026 · 25 min read
Tavneos on Formularies as FDA Moves to Withdraw: The Coverage Dilemma
Specialty· August 16, 2026 · 17 min read
Leqembi IQLIK Launches: Subcutaneous Lecanemab Moves to Specialty Pharmacy
Policy· August 14, 2026 · 18 min read
FDA AEMS Explained: FAERS Replacement, Dashboard, & Safety Pipelines
By Ran Chen#Policy#FDA Approval#Clinical Evidence
Specialty· August 14, 2026 · 24 min read
Multiple Myeloma Treatment Access Landscape: Generic Revlimid, Zenbexus, & Darzalex
Approvals· August 13, 2026 · 25 min read
Tudriqev (RP1): FDA Approval of Second Oncolytic Virus for Melanoma
By Ran Chen#FDA Approval#Accelerated Approval#Oncology
Approvals· August 12, 2026 · 34 min read
Gilead's BIC/LEN Single-Tablet HIV Regimen: PDUFA, Phase 3, and Access
By Ran Chen#FDA Approval#HIV#Gilead Sciences
Approvals· August 12, 2026 · 39 min read
MK-6240 (Florquinitau F-18) Tau PET: PDUFA, Tauvid, and CMS Coverage Gap
By Ran Chen#FDA Approval#PDUFA Date#Medicare