French Senate offers a class action mechanism that could impose a 50% penalty on drug firms.
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The FDA's Oncologic Drugs Advisory Committee will consider whether appropriate dosages of belantamab mafodotin have been identified for two second-line, multiple myeloma indications. Ocular toxicities and large number of dose modifications in trials raised FDA concerns about benefit-risk.
The official separation of those impacted by the reduction-in-force and some others who are leaving the agency are not yet reflected in CDER employee gains and losses data.
A new plan to tackle medicine shortages proposes to develop a set of incentives for companies to manufacture essential medicines in Spain.
