Generics Bulletin previews some of the most noteworthy and anticipated events on the way for the off-patent industry in November 2026.

The new US FDA facility lifecycle program under BsUFA IV will let biosimilar sponsors discuss manufacturing risks before ...

Medline has announced its exit from the bed market alongside an FDA safety alert detailing fire and entrapment hazards tied ...

At an Oct. 30 meeting related to Sydnexis’ formal dispute of an FDA complete response letter, advisory committee members ...

Summit’s ivonescimab and Roche’s giredestrant lead a 14-novel-agent lineup, where the FDA could reject nine and still beat ...

Stryker cut 2026 organic growth guidance to 6.5–7% as softer hip and knee procedure trends, vascular supply constraints and ...

The breast cancer drug represents a major launch for AstraZeneca, and a bellwether for pricing in the most favored nation era ...

Dren Bio raised $350m, Pathos AI closed a $237m series E round and Warp Sciences emerged with $215m in recent venture ...

The company is keeping a tight grip on costs as seeks to reach its goal of $80bn in revenues by 2030. AstraZeneca has ...

MNCs cut prices on 23% and Indian firms on 90% of their listings in a document released by the Indian drug pricing authority ...

During the third quarter earnings call, the firm stressed it has the capacity for targeted dealmaking and wants to add in obesity, as it introduces sub-Q Skyrizi for Crohn’s.

The FDA will settle evidence plans early in development rather than debating regulatory flexibility case-by-case at the end ...