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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. Read More
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. Read More
The panel concluded that the absence of in vitro neutralization activity strongly suggests absence of clinical effectiveness of these monoclonal antibodies. Read More
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 fee legislation isn’t reauthorized by Congress — and yet Congress still has not completed the vital legislation. Read More
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 of compliance with good manufacturing practice. Read More
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. Read More
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 held from September 12 to 15. Read More
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 drugmakers for keeping their drug prices high, the Initiative for Medicines, Access & Knowledge (I-MAK) says in its new report. Read More