A scathing congressional report has detailed communications described as "inappropriate" and "atypical" between Biogen and the FDA regarding the approval of Alzheimer...

The FDA’s cadre of Indian manufacturing investigators has dished up yet another warning letter. This time, the dishonor goes to the local branch of Dutch antibiotics ...

Amid a major restructuring and the spinoff of generics unit Sandoz, Novartis isn't done shaking things up. The pharma giant has sold five of its ophthalmic drugs to ...

The clock is ticking on Vanda Pharmaceuticals’ sleep disorder drug Hetlioz—and, Tuesday, it got louder. A federal court in Delaware has not only rejected Vanda’s cla...

The battle to absorb rare disease drugmaker Horizon Therapeutics will be waged with cash. That was the message from interested bidders Sanofi and Amgen, at lea...

As the salad days of pandemic vaccine sales wane, two mRNA camps are taking a legal stand on the global stage—and duking it out in the name of drug delivery. I...

Thanks to a huge end-of-year splurge, AbbVie’s immunology drug Rinvoq has retaken the top spot as having the biggest TV drug ad spend in November, knocking down Octob...

Last month, the FDA showed it may be ready to play ball on approving nonprescription naloxone. Now, one of the overdose reversal drug’s flagship brands—Emergent BioSo...

When Eli Lilly’s Verzenio snagged an FDA go-ahead to treat certain breast cancer patients after surgery, the first-in-class nod was weakened by an unexpected limitati...

Following a biopharma industry trend, Kyowa Kirin is narrowing its focus by offloading some mature medicines. The Japanese drugmaker will spin its internationa...