Food and Drug Administration (FDA)
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The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis’ drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity at 48 weeks.
There are several scheduled PDFUA dates for the U.S. Food and Drug Administration over the next two weeks. Here’s a look.
The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg).
According to multiple reports, President Donald Trump is set to pick Hahn, a noted radiation oncologist, as the successor to Scott Gottlieb.
Motif Bio plc announced unaudited financial results for the half year ended June 30, 2019 and reported on its progress year to date.
The U.S. Food and Drug Administration (FDA) rejected the company’s inhaled triple-combination therapy, PT010, now known as Breztri Aerosphere.
Janssen’s Invokana snagged another regulatory approval to reduce the risk of end-stage kidney disease, cardiovascular death and worsening of kidney function in adults with type 2 diabetes and diabetic kidney disease.
IntelGenx Corp., a leader in pharmaceutical films, announced that it has resubmitted its 505 New Drug Application for RIZAPORT® VersaFilm® for the treatment of acute migraines to the U.S. Food and Drug Administration.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
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