We came across a bullish thesis on Ultragenyx Pharmaceutical Inc. on Valueinvesting subreddit by bluespacecolombo. In this ...

Authorities like the South African Health Products Regulatory Authority (SAHPRA), the FDA (in the USA), and the EMA (in ...

Adding to its momentum, Ultragenyx Pharmaceutical Inc. (NASDAQ:RARE) recently gained Health Canada approval to expand the use ...

Analysts say the departure of the CBER head may alleviate overhang in the cell and gene therapy space. Vinay Prasad, head of the Center for Biologics Evaluation and Research (CBER) at the US Food and ...

After Loomer targeted surgeon general nominee and Kennedy ally Casey Means, Means’s brother, Calley, suggested that Loomer’s ...

For University of Montana marketing researcher Jesse King, commercials – namely pharmaceutical advertisements – are intensely ...

Tidmarsh will temporarily guide CBER’s regulatory activities while the FDA searches for a permanent department lead.

As Eli Lilly rolls ahead with a $27 billion investment to prop up four new manufacturing facilities in the U.S, the company ...

Dr George Tidmarsh, a former pharmaceutical executive who joined the FDA this month, will take over Prasad’s role temporarily.

The FDA has approved Ascendis Pharma’s Skytrofa (lonapegsomatropin-tcgd, developed as TransCon hGH) for the treatment of adults with GHD.

After a decade of development, a Kansas City-based pharmaceutical company is on the brink of submitting its ADHD medication ...

From innovation in manufacturing to more-flexible regulation and better communication with payers, much needs to happen to ...