Moderation was a theme of the year in novel approvals, as CDER’s median review time rose for the first time in five years and even the center’s fastest approval took more than seven months. A Pink Sheet infographic breaks down which review pathways did the best last year. 

After years of underfunding, stigmatization and lack of research, companies working on products and services that address women’s health care are gaining traction. But the sector also faces unique challenges, such as gaining approval for ads on major social media platforms.

In this week's podcast version of Five Must-Know Things: Merck & Co. tells Scrip oncology will remain a key priority; J&J is responsibly cautious on growth; Takeda pays big for HutchMed drug; industry looks at likely US IRA impact; and lecanemab misses out on EU fast-track treatment.

Shoreline picks up technology platform rights and access from Editas, which recently reduced staff. Hyloris out-licenses commercial rights to Maxigesic in nine EU markets to Salus.