The year ahead in clinical trials looks set to be one that is challenged and influenced by regulatory developments, new guidance, and broader political shifts.

Biogen’s applications for the higher dose regimen of spinal muscular atrophy (SMA) drug Spinraza are now under review in the US and Europe.

The FDA has granted orphan drug designation (ODD) to Zai Lab’s ZL-1310, aimed at treating small cell lung cancer (SCLC).

Emergent Biosolutions (Gaithersburg, US) has purchased US and Canadian rights to Kloxxado, adding to its opioid overdose ...

Disc Medicine finalised the pivotal Phase III trial design of bitopertin in erythropoietic protoporphyria (EPP) with the FDA ...

The FDA reported that six patients died after being injected with Teva’s Copaxone or Sandoz’s Glatopa. The US Food and Drug ...

Cellipont and Secretome Therapeutics are set to enter a collaboration for the manufacturing of the latter’s cellular therapy, ...

Viralgen and Axovia are set to form a partnership to progress the development and manufacturing of gene therapy for retinal ...

Catalent, a global contract development and manufacturing organization (CDMO), has been recognized with two awards in the ...