The FDA slams Lundbeck for now-deleted Vyepti webpages claiming
The FDA has chastised Lundbeck Seattle Biopharmaceuticals for two promotional webpages, neither of which is still online, that made allegedly inflated claims regarding the efficacy …
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Lundbeck’s online promotion of migraine med Vyepti has caught the attention of the FDA, with the agency inking an untitled letter…
The FDA has hit QOL Medical with an untitled letter over emails about Sucraid, accusing the company of creating a misleading…
As Amgen prepares to defend Tavneos’ market approval in the U.S., the company has received a bad omen overseas, with regulators…
Outlook Therapeutics has notched a win in its uphill battle to commercialize an ophthalmic version of Roche’s Avastin…
EMA's CHMP recommends revoking Tavneos' marketing authorization over flawed clinical data, as US approval also hangs in the…
The FDA has paused a controversial policy of releasing letters describing its rationale for rejecting drugs, Fierce Biotech has…
