The Food and Drug Administration and the European Medicines Agency will share data about studies meant to show whether generic drugs are equivalent to their branded counterparts, under a joint program announced Wednesday.
A panel of experts at the Food and Drug Administration has recommended approval for an experimental biotech drug under development by Bristol-Myers Squibb and AstraZeneca for a group of rare metabolic disorders.
An expert panel at the Food and Drug Administration has given a thumbs-up to an experimental drug made by Takeda Pharmaceutical Co. for treating ulcerative colitis and Crohn's disease, the drug maker said.
Teva Pharmaceutical Industries anticipates that it could lose about $500 million in sales next year if a generic version of its multiple sclerosis drug hits the market, the Israeli drug maker said Tuesday.
Compounding pharmacies that produce sterile drugs can register as outsourcing facilities and may be exempt from certain Food and Drug Administration approval requirements, according to a document published on the FDA's website.