This month Takeda struggles to find the bright side of disappointing phase 3 data, Pfizer touts “unprecedented” lung cancer success, NS Pharma’s Duchenne muscular dystrophy drug fails in phase 3,…

Merck and Daiichi Sankyo’s non-small cell lung cancer drug suffered a setback with the companies’ receipt of an FDA complete response letter (CRL) identifying third party manufacturer inspection issues as…

The ongoing effort by the FTC to remove what it labels improper and inaccurate — or “junk” — listings of drug patents in the FDA’s Orange Book continues, with all…

In this edition of Quick Notes EU, we take a peek at new advice regarding phthalates in medical devices, advice for drugmakers facing shortage woes and Finland’s worry over the…

The FDA issued a complete response letter (CRL) for foscarbidopa/foslevodopa (ABBV-951) based on observations from an inspection at one of AbbVie’s third-party manufacturing facilities, the company announced yesterday. Source: Drug…

In a reversal of the previous court’s decision, the US Court of Appeals for the Federal Circuit gave Amarin a win in its fight over Hikma’s generic version of Amarin’s…

The seven-year effort to modernize FDA’s New Drugs Regulatory Program (NDRP) has paid off, with improvements in assessing drug approval applications, monitoring drug safety, operational efficiency and recruiting and retaining…

Finding troubling irregularities in their analysis of FDA’s foreign drug manufacturer inspections, House Energy and Commerce Republicans are pressing the agency for answers. Source: Drug Industry Daily

The FDA is seeking comments on both its information technology (IT) and its customer experience strategies to guide its work and its allocation of budget and resources in the coming…

Novo Nordisk announced plans to invest $4.1 billion to build a fill and finishing manufacturing facility in North Carolina and grow its ability to produce current and future injectable treatments…