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Human medicines European public assessment report (EPAR): Avamys, fluticasone fu...
Human medicines European public assessment report (EPAR): Cimzia, certolizumab p...
Human medicines European public assessment report (EPAR): Iclusig, ponatinib, Da...
Human medicines European public assessment report (EPAR): Flucelvax Tetra, influ...
Septerna stood out from the crowd of biotech IPOs last year due to the lack of c...
The cuts hit the FDA's medical device center particularly hard, including review...
Human medicines European public assessment report (EPAR): Imjudo, tremelimumab, ...
Penmenvy, which protects against five common types of disease-causing bacteria, ...
ICU Medical has voluntarily recalled two lots of potassium chloride intravenous ...
Human medicines European public assessment report (EPAR): Spexotras, trametinib,...
In this edition of STAT Health Tech: HHS cuts impacting AI regulation at FDA, am...
Biogen has refueled its R&D engine, paying Stoke Therapeutics $165 million upfro...
Human medicines European public assessment report (EPAR): Vyndaqel, tafamidis, D...
Human medicines European public assessment report (EPAR): GoResp Digihaler (prev...
Checklist for the submission of Type IA and Type IB (without linguistic review) ...
Changing the labelling and package leaflet (Article 61(3) notifications)
And other biotech stories from the past weekend.
Transfer of marketing authorisation: questions and answers
Argenx is urging patients to “Live Vyvidly.” The biotech put the message out in ...
Thousands of U.S. health agency employees were terminated and told it was for po...