China’s FDA joined ICH, Takeda completed new solid dosage plant, the FDA bans imports of Ipca drugs.

Just a month after FDA staff gave a ringing endorsement to Pfizer's biosimilar for Amgen's blockbuster Epogen, the agency rejected the drug.

Shingrix met its goal in a study examining whether it can protect older adults who previously received Merck’s Zostavax.

The EU's highest court ruled that EU national courts don't need scientific proof to consider a vaccine as defect.

Full results from BMS' Opdivo monotherapy trial in first-line lung cancer are finally out—alongside a theory about why that trial came up short.

A federal jury has found that Teva must pay GlaxoSmithKline $235 million in a carve-out patent case over heart drug Coreg.

Orphan drug sales have nearly doubled since 2008, a trend set to continue through 2022 as companies increasingly focus on rare disease meds.

Russia is pushing back on an issue that has raised concerns around the world: cancer drug prices.

Seqirus said it has achieved an industry first by producing a cell-based influenza vaccine on a commercial scale using a virus grown in cells.