Pink Sheet - News And Expert Analysis On Pharma Policy And Regulation since 1939

The European Medicines Agency's green light for Redemplo adds to a rapid run of regulatory wins for Arrowhead Pharmaceuticals, which has secured approvals for the familial chylomicronemia syndrome drug in the US, China and Canada in the past six months.

Sanofi’s regulatory rollercoaster with tolebrutinib continues as the European Medicines Agency backs the multiple sclerosis drug that was rejected in the US but provisionally approved in the UAE.

The intrathecal formulation of Novartis’s gene therapy for spinal muscular atrophy, which is already approved in the US, has received the thumbs up from the European Medicines Agency.

Treatment for deafness is the first gene therapy approved under the FDA Commissioner’s National Priority Voucher program.

Chastened by FDA's rejection of Lykos' MDMA, the psychedelic drug pipeline is arriving at the agency with slimmed-down clinic times, minimal psychotherapy, and placebo-controlled trial designs, just as a Trump Executive Order promises to fast-track their review.

National language translations of patient‑facing documents are being relocated within the EU Clinical Trials Information System to cut upfront administrative and cost burdens for sponsors filing partial study applications.