First-ever rapid-acting insulin. This approval extends to a 3-milliliter single-patient-use prefilled pen and a 10-milliliter ...

Pharm Exec’s 20th Annual Pipeline Report examines the emerging drug development trends and surging investments in five ...

President Donald Trump recently issued two executive orders furthering his policy to reduce the number of federal regulations and the size of ...

Geron could have a tougher time than it anticipated at tomorrow’s FDA advisory committee meeting for myelodysplastic syndromes (MDS) drug candidate ... with MDS each year in the US, with 70% ...

The high cost of sickle cell gene therapies is pushing private insurers and Medicaid programs to develop new payment models.

"Net sales increased during the fourth quarter by 41.5 percent to SEK 64.2 million, compared with the corresponding quarter of 2023. The growth and strong performance are a result of robust developmen ...

Reports fourth quarter revenues of $1.0 billion, GAAP net loss of $(1.1) billion and GAAP EPS of $(2.91); loss includes approximately $0.2 billion of non-cash charges related to manufacturing resizing ...

The FDA has awarded fast ... EU and Australia went against approval. The EU is carrying out a re-examination of the drug which is due to complete later this year. Biogen reported this week that ...

The drug, which is currently approved as Sunlenca for multi-drug resistant HIV, would be the first twice-yearly PrEP option on the market. The company’s FDA ... a year of treatment. That number ...

One of Trump’s biggest complaints was that the agency was too slow to alert the world of an emerging health threat in China ...

Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with ...

The U.S. Food and Drug Administration has approved a new drug application for a tablet version of Evrysdi (risdiplam) for ...