The Latest Breaking News from PFE

The FDA has granted Breakthrough Therapy Designation to Pfizer Inc's (NYSE:PFE) respiratory syncytial virus (RSV) vaccine candidate (PF-06928316 or RSVpreF) to prevent lower respiratory tract disease caused by RSV in 60 years of age or older. The positive results primarily inform the FDA decision of Phase 2a study evaluating the safety, immunogenicity, and efficacy…

Pfizer Inc (NYSE:PFE) has announced topline results from a Phase 3 study of etrasimod in moderately to severely active ulcerative colitis (UC).  In the study, etrasimod patients achieved statistically significant improvements in the primary endpoint of clinical remission at week 12 compared with placebo.  Statistically significant improvements were achieved in all key secondary…

Pfizer Inc (NYSE:PFE) voluntarily recalls Accuretic (quinapril HCl/hydrochlorothiazide) and two authorized generic versions due to the presence of nitrosamine, N-nitroso-quinapril, above an acceptable level.  Pfizer will recall six lots of Accuretic tablets, one lot of quinapril and hydrochlorothiazide tablets, and four lots of quinapril HCl/ hydrochlorothiazide tablets. Nitrosamines are common in water and…

Thirty-five generic drugmakers will produce low-cost versions of Pfizer Inc's (NYSE:PFE) COVID-19 pill, Paxlovid, to expand supplies of the highly effective drug in lower-income regions. Pfizer struck a deal last year with the group to allow generic drugmakers to make the pills for 95 low- and middle-income countries, covering up to approximately 53% of the…