Exactech has initiated a recall to remove Equinoxe shoulder system devices packaged in defective bags from facilities’ unused inventory the FDA announced in an update of its Jan. 16 safety…
Two pharmaceutical giants based in Japan — Takeda and Astellas — have signed a master agreement along with Sumitomo Mitsui Banking Corporation to establish a joint venture company dedicated to…
Allergan must still face allegations that it violated the False Claims Act by incentivizing physicians to prescribe off-label Botox for pediatric migraine, although a federal circuit court judge dismissed charges…
Yet-to-be-finalized, a proposed FDA rule to update and condense prescription medication guides for consumers, will replace current prescription info that the agency says is confusing, repetitive and conflicting — potentially…
This month we see a prospective IND for a presbyopia eyedrop, a Crohn’s flop, and wins in obstructive sleep apnea and MS. Source: Drug Industry Daily
As the second session of the 118th Congress begins, FDAnews will track important pending legislation, that has been acted on since Oct. 1, 2023 to keep you updated on laws…
The Department of Justice (DOJ), HHS and the FTC have jointly launched a public-facing portal for reporting unfair and anticompetitive practices that the Biden administration says will support its efforts…
In this edition of Quick Notes, AstraZeneca nabs a new indication for a severe asthma drug, Alvotech and Teva win FDA approval for a Stelara biosimilar, Takeda secures approval for…
Stagnant liquid inside an air purification unit, hundreds of complaints on tablet counts and inadequate guidance to call centers are but a few of the litany of issues outlined in…
Drugmakers could make more use of regulatory intelligence to hone their approach to supplier oversight, according to one quality expert. Source: Drug Industry Daily