Bristol Myers Squibb and bluebird bio, Inc. announced the submission of their Biologics License Application (BLA) to the FDA for idecabtagene vicleucel (ide-cel; bb2121), the companies’ lead investigational… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nepexto, intended for the… read more.
Seqirus, a global leader in influenza prevention, announced that its adjuvanted quadrivalent influenza vaccine (aQIV) – launching as Fluad Tetra – has received a positive opinion from the… read more.
Horizon Therapeutics announced new pooled efficacy data from the Phase II and III clinical trials of Tepezza (teprotumumab-trbw) showing that the recently approved medicine effectively reduces proptosis (eye… read more.
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional marketing authorisation for the medicinal product Pretomanid FGK, intended… read more.
A new retrospective data analysis published in Kidney Medicine shows that a higher percentage of hemodialysis patients prescribed Velphoro (sucroferric oxyhydroxide chewable tablets), from Fresenius Medical, achieved target… read more.
Regeneron Pharmaceuticals announced that detailed Phase III ELIPSE HoFH trial results of REGN 1500 (evinacumab) in patients with homozygous familial hypercholesterolemia (HoFH). The data showed the trial met… read more.
Regeneron Pharma has presented Phase III ODYSSEY HoFH trial results from a late-breaking presentation, demonstrating the effect of Praluent (alirocumab) in patients with homozygous familial hypercholesterolemia (HoFH). The… read more.
Axsome Therapeutics announced that AXS 05 (bupropion + dextromethorphan) met key secondary endpoints in the STRIDE-1 trial by rapidly and statistically significantly improving symptoms of depression on the… read more.
The Dapagliflozin And Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) Phase III trial for Farxiga (dapagliflozin) in patients with chronic kidney disease (CKD) will be stopped… read more.
The European Commission has granted marketing authorisation in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor (ARi), from Orion Corporation and Bayer. The approval… read more.
Merck Inc announced the presentation of results from the VICTORIA trial, a Phase III study evaluating the efficacy and safety of its investigational drug BAY 1021189 (vericiguat), an… read more.
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