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Zecuity Clinical Development Timeline
Chronicle of the development and review of NuPathe's (now Teva's) sumatriptan iontophoretic transdermal system for acute migraine.
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The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
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US FDA’s rejection of Biohaven’s troriluzole is a huge disappointment for patients with SCA and the company. But it is also a notable example of how communication strategies are changing now that FDA is making its ‘complete response’ letters public.
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Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.
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The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.
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‘Why We Would Do It Again’ – Gilead & Roche On Pioneering Global Initiative For Manufacturing Change
Gilead and Roche reflect on their experiences with a global initiative that delivered aligned regulatory decisions through joint hybrid inspections and synchronized review of post-approval changes.
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The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.
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In this exclusive article with Peter Crowley, Secretary and Scientific Director of the BP Commission, you’ll discover how the BP is preparing for its landmark 2026 edition while strengthening its influence as a global bridge between science, regulation, and industry.