Seeking Alpha

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

DBV and FDA aligned on key study design elements for the COMFORT Toddlers study in 1 – 3 year-olds, including study size and wear time collection methodology and analysis COMFORT Toddlers study ...
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 ...
Hosted on MSN

Navigating the FDA’s accelerated approval pathways for oncology drugs

“It would not be surprising to not see new FDA guidance documents issued for some period of time,” said David Larwood, CEO of Valley Fever Solutions, about the potential impact of the US Food and Drug ...
Post and Courier

Commentary: Keep FDA moving forward, not backward

When Vinay Prasad was tapped to lead the Food and Drug Administration’s Center for Biologics Evaluation and Research, the health care world braced for its effect. Known for his critical analyses of ...
Seeking Alpha

Black Diamond: On Right Track For Possible Accelerated Approval Pathway

Black Diamond Therapeutics (BDTX) is a good speculative biotech play to look into. Despite the stock price rising on the back of positive news the other day by as much as 235%, I still believe that ...