Approvals· September 5, 2026 · 29 min read
Topic
Oncology
HER2-targeted therapy, tumor-type access, buy-and-bill reimbursement, oncology biosimilars, and cancer drug coverage.
Approvals· September 4, 2026 · 36 min read
Lirafugratinib's Sept 27 PDUFA Does Not Rewrite Pemazyre PAs or Lytgobi CDx
By Ran Chen#PDUFA Date#FDA Approval#NDA Approval
Specialty· August 31, 2026 · 36 min read
Generic Erleada (Apalutamide): U.S. Entry, Patents, and Launch Signals
By Ran Chen#Oncology#Generic Entry#Orange Book
Approvals· August 29, 2026 · 17 min read
Rasonque's Pancreatic Label Needs No RAS Test: 2L Data Does Not Write 1L Access
By Ran Chen#FDA Approval#Oncology#Coverage Access
Generics· August 27, 2026 · 17 min read
FDA's Cabazitaxel 314.161 Notice: ANDAs to Dead 10 mg/mL NDA, Not Jevtana Kit
By Ran Chen#Generics#Orange Book#505(b)(2)
Pipeline· August 19, 2026 · 16 min read
INTerpath-001 Phase 3: Intismeran Autogene and Keytruda's Post-2028 Strategy
By Ran Chen#Pipeline#Clinical Evidence#Pivotal Trials
Pricing & Access· August 18, 2026 · 18 min read
Ziihera's August 25 Gastric Decision: Bispecific vs Trastuzumab Biosimilars
By Ran Chen#Oncology#HER2#Biosimilars
Specialty· August 15, 2026 · 23 min read
Prostate Cancer Treatment Access Landscape: Xtandi Patent Wall & Generics
By Ran Chen#Oncology#Generic Entry#Orange Book
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
Policy· August 12, 2026 · 38 min read
IARC Group 1 Call on HCTZ, Voriconazole, Tacrolimus: Pharma & P&T Actions
By Ran Chen#FDA#Label Warnings#Formulary Strategy