Targeted Oncology

FDA Oncology Update January 2026: New Horizons in Precision Medicine

On January 12, NP-G2-044 (Prilukae), a novel oral fascin inhibitor earned ODD for the treatment of pancreatic cancer. This designation covers the use of the agent as monotherapy and in combination ...
Healio

FDA approves updated label with new dosing guidance for inhaled insulin

The FDA has approved a label update for an inhaled insulin indicated for adults with type 1 or type 2 diabetes, according to ...
The Healthy @Reader's Digest

A Nationwide Recall of 8,500 ADHD Medication Bottles Just Received an Update from the FDA

With an expiration date still more than a year away, here's what the latest details reveal.
CURE

FDA Updates Safety Warnings for Common Chemotherapy Drugs

A major update appears in the Boxed Warning, the most prominent safety warning required by the FDA. The warning now ...
The Manila Times

UPDATE - Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate (OLC) New Drug Application (NDA) Resubmission

FDA assigns Prescription Drug User Fee Act (PDUFA) target date of June 29, 2026Ended 2025 with unaudited cash position of $41 ...
The Manila Times

SCIENTURE Provides Commercial Update on ARBLI™, the First FDA-Approved Ready-to-Use Oral Suspension of Losartan Potassium

Company highlights accelerating access and revenue growth for ARBLI™ and confirms REZENOPY™ launch timeline, addressing a combined US annual losartan and naloxone market size of close to $385 million ...
Stocktwits on MSN

RGNX stock is falling today — what is the FDA update on REGENXBIO's gene therapy?

The company said that the FDA hold has impacted two experimental gene therapies, RGX-111 and RGX-121. ・REGENXBIO added that ...
Business Insider

Relmada Therapeutics Provides Regulatory Update Confirming FDA Alignment on Registrational Studies Design for NDV-01 for Two Separate Indications

- a single-arm, open-label registrational trial in 2nd-line refractory high-grade NMIBC with CIS - a randomized vs observation single trial in intermediate-risk NMIBC in the adjuvant setting Phase 3 ...