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FDA denies a petition to permit a drug company to submit an ANDA demonstrating bioequivalence to BioMarins Kuvan sold in Israel ra...[ Price : $8.95]
Mallinckrodt asks a Maryland federal court to stop FDA from reclassifying its generic form of Concerta from AB to BX.[ Price : $8.95]
Knight Therapeutics sells to Gilead Sciences for $125 million its Neglected Tropical Disease Priority Review Voucher that was gran...[ Price : $8.95]
FDA grants Merrimack Pharmaceuticals a fast track designation for MM-398 (nanoliposomal irinotecan injection) for treating patient...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Eastern Pharmacy, Dr. Benedict Schue-Schie Liao, MKL Diagnostics, Wells Pharmacy...[ Price : $8.95]
FDA warns Swedens MKL Diagnostics about Quality System violations in its production of diagnostic tests.[ Price : $8.95]
FDA clears an AdvanDx 510(k) for its new mecA XpressFISH assay for detecting methicillin-resistant and methicillin-susceptible Sta...[ Price : $8.95]
The American Clinical Laboratory Association says former solicitor general Paul Clements and Harvard law professor Lawrence Tribe ...