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

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

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 ...

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

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

FDA granted Orphan Drug Designation to Sanofi’s SAR446523, a monoclonal antibody targeting GPRC5D, for relapsed/refractory ...

Trump’s tariff regime has shaken global trade — and Ireland’s critical pharma sector is bracing for long-term change ...

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

FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

Oral, non-opioid drug candidate advancing through Phase 1 and nearing completion of the single ascending dose (SAD) portion ...

Speakers at a congressional briefing on July 22 called on the FDA to take action against the marketing and distribution of ...

AbbVie, Bristol Myers Squibb and Eli Lilly appear “relatively well-positioned,” while Novartis and Roche look more at risk, ...