Pharma News, 2023

Waking up in the middle of the night to take a pill is the onerous way patients take the world’s top-selling narcolepsy drug, Jazz Pharmaceuticals’ Xyrem.

AstraZeneca PLC forecasts for its major Lynparza drug are expected to be trimmed following an advisory vote against full approval in the US. 

After 20 years developing technology for slow-release injectable drugs, MedinCell of France has won its first FDA approval.

After the FDA threw a wrench in Ascendis’ hypoparathyroidism drug application by flagging deficiencies in the filing, the agency has now issued a manufacturing-related complete response letter to...

Aldevron, a subsidiary of Danaher, unveiled plans to expand its mRNA manufacturing operations to include lipid nanoparticle (LNP) encapsulation and aseptic fill-finish capabilities. ...

A labeling problem has forced Teva to recall 13 lots of fentanyl buccal tablets. Safety updates on the product insert were omitted, leaving the possibility of misuse that “could lead to life-thre...

The Food and Drug Administration (FDA) in the US has authorised the first approved drug for a rare form of motor neurone disease (MND) based on the results of a Phase 3 clinical trial completed at ...

Kite – a Gilead Sciences spin out company – has announced that the National Institute for Health and Care Excellence (NICE) has recommended additional uses for their two CAR T-cell therapies. ...

The CHMP’s positive opinion was supported by data obtained from a pivotal Phase II AReSVi-006 trial.

Eli Lilly and Co  on Thursday raised its annual revenue and profit forecasts after topping first-quarter sales estimates on demand for its closely watched diabetes drug Mounjaro, ahead of a d...

Sun Pharma says it's responding to increased pressure from the FDA following a plant inspection last August. 

The EU’s proposal for the biggest shake-up in pharma rules for decades has finally arrived, but companies say they could simply take their innovative medicines elsewhere. ...