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FDA warns Chinas Hubei Pharmaceutical Co. about CGMP violations in its production of active pharmaceutical ingredients.[ Price : $8.95]
Genentech says a Pfizer biosimilar to its Herceptin will infringe 40 Genentech patents and should be barred by a federal court inj...[ Price : $8.95]
A new White House report estimates that the ongoing opioid crisis cost the U.S. $504 billion in 2015 and led to over 33,000 Americ...[ Price : $8.95]
Federal Register notice: FDA acknowledges that an applicant for a proposed biosimilar product notified the agency that a patent in...[ Price : $8.95]
Federal Register notice: FDA makes available a guidance entitled Unique Device Identification: Direct Marking of Devices.[ Price : $8.95]
FDA approves a Kalo supplemental NDA for AUVI-Q (epinephrine injection, USP) 0.1 mg, for treating life-threatening allergic reacti...[ Price : $8.95]
FDA grants PellePharm a breakthrough therapy designation and orphan drug designation for topical patidegib for patients with Gorli...[ Price : $8.95]
FDA approves a Medtronic PMA for its Azure pacemakers with BlueSync technology.