[ Price : $8.95]
Novo Nordisk asks FDA not to approve any ANDA for a drug referencing any of its liragltide-containing drugs and put restrictions o...[ Price : $8.95]
Pfizer tells FDA that an agency draft guidance on CMC postapproval manufacturing changes for specified biological products may con...[ Price : $8.95]
FDA accepts an Allergan NDA for ulipristal acetate, an investigational drug for treating abnormal uterine bleeding in women with u...[ Price : $8.95]
FDA issues a complete response letter for Mylans BLA for MYL-1401H, a proposed biosimilar of Amgens Neulasta (pegfilgrastim).[ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes Diasol, Euro Diagnostica, Option Care, and Laveeza Bhatti.[ Price : $8.95]
FDA accepts for priority review an Ultragenyx Pharmaceutical and Kyowa BLA for burosumab to treat pediatric and adult patients wit...[ Price : $8.95]
FDA medical reviewers ask members of the Cellular, Tissue, and Gene Therapies Advisory Committee for their opinion on difficult qu...[ Price : $8.95]
Reps. Brooks and Trott introduce a bill creating a public-private partnership to protect Americans sensitive healthcare informatio...