A Senate committee will vote whether to approve Robert Califf’s nomination to become FDA commissioner on Wednesday, Jan. 12 — a critical step before the full chamber can hold a…

Applied Therapeutics got some coal in its stocking last week, when the FDA said the company needs clinical outcomes data, not just biomarker numbers, to support a New Drug Application…

Novartis Gene Therapies’ Libertyville, Ill., plant, which produces Zolgensma — the world’s most expensive drug at more than $2.1 million per treatment — has drawn a Form 483 with five…

The FDA has approved Xeris Biopharma’s Recorlev (levoketoconazole) for treating hypercortisolemia in adults with Cushing’s syndrome who are unable to undergo surgery. Source: Drug Industry Daily

CoronaVac, Sinovac’s COVID-19 vaccine, appears to be completely ineffective against the Omicron variant unless boosted with an mRNA vaccine, new data suggest. Source: Drug Industry Daily

The approach taken by drugmakers during the pandemic turned out COVID-19 vaccines in record time, but it has some shortcomings for use in future drug development and manufacturing, according to…

The FDA is poised to authorize a third booster dose of the Pfizer-BioNTech COVID-19 vaccine for use in adolescents aged 12 to 15. Source: Drug Industry Daily

A federal court has rejected Sanofi’s attempts to reinstate key patents covering a drug-device combination product dispensing its insulin blockbuster Lantus. Source: Drug Industry Daily

A New York jury has found Teva Pharmaceuticals guilty of fueling the state’s opioid crisis through misleading marketing about the risks of its highly addictive painkillers. Source: Drug Industry Daily

BridgeBio’s investigational cardiomyopathy molecule acoramidis (AG10) fell short of the phase 3 finish line this week, when it not only failed its primary endpoint, but was associated with decreases in…