Yahoo Finance

DBV Confirms Alignment with U.S. FDA on Accelerated Approval Pathway for the Viaskin® Peanut Patch in Toddlers 1 – 3 Years-Old

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company, today announced the successful outcome of recent written and oral ...
Medscape

Accelerated Approval Pathway for Cancer Drugs: Does It Work?

Accelerated approvals for cancer drugs is a good idea in theory. This US Food and Drug Administration (FDA) pathway allows promising new cancer agents to reach the market, and patients, sooner. But ...
FiercePharma

FDA's accelerated approval pathway needs stronger transparency, evidence standards: ICER

The FDA should strengthen the evidence required for drug approvals under its accelerated pathway and increase transparency surrounding those regulatory decisions, according to a report (PDF) from a ...
Business Wire

4Moving Biotech Granted FDA Fast Track Designation to 4P004, Supporting an Accelerated Development Pathway in Knee Osteoarthritis

LILLE, France & PARIS--(BUSINESS WIRE)--4Moving Biotech (4MB), a clinical-stage biotechnology company developing next-generation Disease-Modifying Osteoarthritis Drugs (DMOADs), today announced that ...
RAPS

FDA: Genome editing therapies may use accelerated approval pathway

The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human somatic cells; the final version ...