The decision to discontinue the study was made based on an analysis from an independent data and safety monitoring board.
Each capsule contains 140mg of bismuth subcitrate potassium, 125mg of metronidazole, and 125mg of tetracycline hydrochloride.
The product was designed using the Amphastar’s proprietary nasal delivery device.
The new autoinjector is designed with push-on-skin activation to be used in both in-office and at-home settings of care.
The application is supported by data from the pivotal phase 3 B-SIMPLE4 study which included 891 patients 6 months of age and older with molluscum contagiosum.
M-M-R II, Varivax, and ProQuad are supplied in single-dose vials as lyophilized vaccine for SC or IM injection after reconstitution.
The Lucira COVID-19 & Flu Home test is a single-use, nucleic acid amplification test intended for individuals with signs and symptoms consistent with a respiratory tract infection.
To assess the potential risk, the FDA is working with manufacturers of neonatal incubators and evaluating data from their products.
The BLA is supported by data from a phase 3 trial which included approximately 7400 pregnant individuals.
The MOVe-AHEAD study enrolled over 1500 participants 18 years of age and older who resided in the same household with someone who tested positive for SARS-CoV-2.
Rebyota is a fecal microbiota suspension for rectal administration.
The study analyzed 29,278 women who were in labor at 28 weeks’ gestation or more and who were planning a vaginal delivery.
The letters cite violations related to drug misbranding failing to bear adequate directions for their intended use(s).
The CDC is urging health care providers and patients to immediately discontinue use of EzriCare Artificial Tears.
The FDA has revised the EUAs for Paxlovid and Lagevrio for the treatment of mild to moderate COVID-19.
The 20vPnC vaccine consists of capsular polysaccharide conjugates for the 13 serotypes included in Prevnar 13, along with 7 additional serotypes that cause invasive pneumococcal disease.
The BLA is supported by data from a clinical trial which included 2341 healthy individuals 10 through 25 years of age.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The issue appears to be related to the availability of generic oseltamivir.
The bivalent vaccine contains the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The BLA is supported by data from the phase 3 RENOIR trial which included approximately 37,000 adults 60 years of age and older.
The all-oral and combination treatment arms demonstrated statistically significant composite responses of 10.1% and 19.2%, respectively.
The bivalent vaccine contains the original strain of the SARS-CoV-2 virus and a strain from the BA.4 and BA.5 lineages of the Omicron variant.
The BLA is supported by data from the pivotal TIDES trial which included over 20,000 patients 4 to 16 years of age.
Kineret is an interleukin-1 receptor antagonist.
The approval was supported by data from a phase 2 trial that included 70 patients aged 12 to less than 18 years with chronic HBV infection.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
SER-109 contains purified bacterial spores of multiple Firmicute species obtained from the stool of healthy human donors.
The Menveo 1-vial presentation does not require reconstitution before use and is expected to be broadly available in mid-2023.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
