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US FDA rejects Valeant’s Duobrii for plaque psoriasis

The US FDA has rejected Valeant Pharmaceutical International’s investigational topical treatment for plaque psoriasis, Duobrii.

Mylan awaits US FDA rejection for GSK generic

Mylan says ‘minor deficiencies’ in its abbreviated new drug application for its proposed generic version of GSK’s Advair Diskus have prompted the US FDA to issue a complete response letter.

DSP expanding statins portfolio with EU launch of generic Atorvastatin

DSP has released its generic Atorvastatin drug product within the EU with additional markets to be added later this year the firm looks to become a full-service generics company.

Recipharm buys Sanofi CMO site in UK, signs long-term supply deal

Sanofi is handing off its Holmes Chapel facility and all existing contract manufacturing agreements to CDMO Recipharm.

US FDA warns Taiwan Biotech for ‘dubious’ reports at manufacturing site

A lack of ‘basic documentation’ and ‘dubious’ environmental control system reports at Taiwan Biotech’s manufacturing plant were cited in the US FDA warning letter.