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The FDA approved Amgen’s Repatha late Thursday for some patients who are not able to control low-density lipoprotein cholesterol using standard treatment options, making it the second PCSK9 inhibitor to receive the agency’s blessing. Read More
A federal judge Wednesday said AbbVie and Teva can continue an arrangement that delays the launch of generic versions of the testosterone drug Androgel — rejecting the FTC’s request that he reconsider his earlier decision that the agreement was not pay-for-delay. Read More
The FDA handed Baxter Healthcare a six-observation FDA Form 483 for lapses in sterile process controls and failure to review batch discrepancies at its Puerto Rico manufacturing plant. The drugmaker has been plagued in recent months over recalls of sterile IV solutions. Read More
The FDA Thursday released long-awaited draft guidance on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
Patients who got a combination of GlaxoSmithKline’s Volibris and Eli Lilly’s Adcirca to treat pulmonary arterial hypertension had significantly less hospitalization, disease progression or death compared with those getting monotherapy in a Phase 3b/4 study, newly released data show. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More