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The FDA’s decision will close a lucrative market opportunity for compounding pharmacies, although the agency will give a limited grace period before taking any enforcement actions.

Results from a study called Mariposa found a regimen of Rybrevant and Lazcluze helped patients with a common form of advanced lung cancer live longer.

Political and economic uncertainty hangs over the industry, while major bets on metabolic and immune disease drug research are set to play out.

The CRISPR gene editing company will reduce its workforce by 27% over the course of the year as it discontinues a treatment for alpha-1 antitrypsin deficiency.

The director of the FDA's main drug review office will exit on Jan. 18, according to an email sent to staff. Her departure is one of several announced by high-ranking FDA leaders ahead of the coming administration change.

Intra-Cellular has had success selling Caplyta, a brain-rebalancing drug that's approved to treat schizophrenia and bipolar depression.

Young drugmakers confront several harsh realities this year, among them a contracting sector and competition from China.

Nippon Shinyaku will pay Regenxbio $110 million upfront for U.S. and Asia rights to treatments for Hunter and Hurler syndromes.

AbbVie's CEO hinted his company may be less willing to invest in psychiatry after a costly setback, while Lilly explained what it got wrong forecasting GLP-1 drug demand.

The pharma expects a modest financial headwind this year from changes to Medicare prescription drug benefits under the Inflation Reduction Act.