Tecarfarin is a novel oral vitamin K antagonist with a similar mechanism of action to warfarin, though it is metabolized differently.
Under the FDA’s orders, the Company may not market or distribute these products in the US.
Airsupra is a first-in-class, pressurized metered dose inhaler, fixed-dose combination of albuterol and budesonide.
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.
BresoDX1 is designed to record a patient’s physiological signals during sleep using a sensor and a pulse oximeter.
The approval was based on data from 2 clinical trials that compared Xenoview MRI to xenon Xe 133 scintigraphy in adults with pulmonary disorders.
The ready-to-dilute formulation was developed to eliminate the reconstitution step with Alimta.
Actemra (tocilizumab) is an interleukin-6 receptor antagonist.
The ENHANCE-1 trial evaluated nebulized ensifentrine as monotherapy or as an add-on to a LAMA or a LABA in patients with moderate to severe COPD.
The approval was based on data from the phase 3 ELUCIDATE study.
Krazati is a highly selective and potent oral small molecule inhibitor of KRASG12C.
The combined vaccine is intended to simplify immunization practices against 2 severe respiratory diseases caused by evolving viruses that require vaccine adaptation.
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 bivalent formulations contain 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 approval was based on data from a phase 3 POSEIDON study.
Kineret is an interleukin-1 receptor antagonist.
Findings showed that treatment with cemiplimab-rwlc plus platinum-based chemotherapy demonstrated a statistically significant improvement in overall survival.
Sapanisertib is a dual mTORC 1/2 inhibitor that targets a key survival mechanism in KEAP1/NRF2-mutated tumor cells.
Alvelestat is an investigational oral neutrophil elastase inhibitor designed to protect AATD patients from further lung damage.
The RSVpreF vaccine candidate consists of 2 prefusion F proteins selected to optimize protection against RSV A and B.
Evusheld is a combination of 2 long-acting monoclonal antibodies designed to bind to distinct sites on the SARS-CoV-2 spike protein.
SnoreStop NasoSpray is a nasal spray used to temporarily help stop or reduce symptoms of nonapneic snoring.
Results showed both trials of leronlimab did not meet primary or secondary endpoints.
The sNDA is supported by data from the multicenter, double-blind, placebo-controlled phase 3 INCREASE study.
The Food and Drug Administration provided an update on its efforts to combat the sale of fraudulent products during the coronavirus disease 2019 pandemic.
Treatment with interferon beta-1b in combination with lopinavir/ritonavir and ribavirin was found to be safe and superior to lopinavir/ritonavir alone for reducing the duration of viral shedding and hospital stay in adults with COVID-19.
The FDA has approved the Investigational New Drug application for the phase 2a study of opaganib in patients with confirmed moderate to severe SARS-CoV-2 infection.
Positive topline data from the phase 2b study of INOpulse® delivery system announced for the treatment of pulmonary hypertension associated with pulmonary fibrosis.
Bellerophon Therapeutics announced positive topline results from cohort 2 of a study of INOpulse delivery system for PH-ILD.
Healthcare professionals are being advised to monitor patients regularly for pulmonary symptoms indicative of ILD and/or pneumonitis, including hypoxia, cough, dyspnea, and interstitial infiltrates on radiologic exams.
