In addition to being interchangeable with their reference products, biosimilars approved in the EU are interchangeable with an equivalent biosimilar, the European Medicines Agency (EMA) and the EU’s Heads of…

Resolving allegations that it violated the False Claims Act, generic drugmaker Akorn has entered into a settlement to pay $7.9 million for causing Medicare to be billed for three over-the-counter…

Vanda Pharmaceuticals is suing the FDA for the third time in 2022 — this time over what the company claims is FDA’s “unlawful” delay in granting a public hearing to…

After a series of rejections, the FDA has finally approved Mallinckrodt’s Terlivaz (terlipressin) for treating adults suffering from hepatorenal syndrome (HRS), a life-threatening condition involving rapid reduction in kidney function.…

Bluebird Bio’s gene therapy Skysona (elivaldogene autotemcel) has snagged accelerated approval as a treatment for early, active cerebral adrenoleukodystrophy (CALD), an invariably fatal genetic disorder that strikes young boys. Source:…

There are only twelve days until Sept. 30, the end of the fiscal year — the point at which the FDA faces potentially laying off thousands of employees if user…

Particulars of the 13 inspection observations that stopped the FDA from approving biosimilars developer Alvotech’s biologic license application (BLA) for AVTOC2 draw a picture of a manufacturing facility seriously out…

A spate of phase 3 data hit the wires this week. Here’s a brief look at the numbers from Alexion, Merck, AstraZeneca and Bristol Myers Squibb. Source: Drug Industry Daily

An expert panel of the European Medicines Agency (EMA) recommended 12 new drugs and embraced therapeutic extensions for 11 medicines already authorized in the EU at its latest monthly meeting…

Filing for hundreds of additional patents for drugs already approved by the FDA in order to fend off market entry by generics and biosimilars is the key strategy among many…