Regulators are warming to real-world evidence in device submissions, but the FDA has identified a recurring failure mode: ...

FDA's drug review chief wants artificial intelligence to do what regulators can no longer do after a wave of retirements: ...

The FDA granted full approval to Lilly’s oral SERD imlunestrant, expanding its label from monotherapy to include combination ...

With Fayuvi now approved, Ultragenyx turns to building treatment-center capacity, securing payer access and identifying ...

Corcept Therapeutics’ Lifyorli and Impact Therapeutics’ Sepalna are on track for pan-EU marketing approval to treat patients ...

After the European Medicines Agency upheld its negative opinion for Xervyteg, MaaT Pharma said it was evaluating strategic funding options to strengthen the drug's evidence package and pursue future ...

The GENEROUS pilot is a closed club – limited to the 26 drug makers that already struck MFN deals with the Trump administration. The program's prices, and even which products are part of it, are still ...

The two companies are looking to catch up with rivals in AI-assisted drug discovery, and want to help train AI to think like ...

US FDA counters concerns about rising rates of complete response letters with a longitudinal analysis showing long-term ...

The company filed for approval of the drug in focal seizures, but it paused new enrollment in psychiatric studies due to adverse events.

New treatments from AstraZeneca and Xcovery/Betta Pharmaceuticals for generalized myasthenia gravis and ALK-positive advanced non-small cell lung cancer, respectively are on track for EU-wide ...

Aurobindo's generic equivalent of Teva's branded QVAR inhaler has gained approval from the US regulator, following ...