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

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

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, ...

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

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

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

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

Tagrisso and Imfinzi are projected to generate global sales of $8bn and $7bn, respectively, by 2030, according to GlobalData.

Panellists at the World Economic Forum 2025 Davos meeting discussed how artificial intelligence (AI) could help close the gap ...

The FDA placed a clinical hold on two Atara assets, following an inspection at a third-party site that also led to a CRL for ...

The US FDA has granted breakthrough therapy designation to Bluejay Therapeutics’ brelovitug, to treat chronic hepatitis delta ...