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news.ViiV Healthcare seeks FDA approval for cabotegravir plus rilpivirine to treat HIV
The company has submitted a new drug application (NDA) to the FDA for two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who
The company has submitted a new drug application (NDA) to the FDA for two-drug regimen to treat HIV-1 infection in adults whose viral load is suppressed and who
The indication the CHMP adopted is for TALZENNA as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene (gBRCA)1/2-mutations, who have human epidermal growth
SLE, simply referred as lupus, is a serious chronic disease that causes inflammation and damage to different body tissues and organs. The FDA provided priority review designation to
Stellar-3 is a randomized, double-blind and placebo-controlled trial, which assessed the safety and efficacy of selonsertib in patients with bridging fibrosis (F3) due to NASH. According to the
This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs
HES is a rare and often incapacitating disorder with limited treatment options. The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to
The investment will help GSK to expand the production capacity of major components of the adjuvant system used in several of its vaccines such as Shingrix, which secured
Prismic is developing novel non-addictive prescription drugs with unique safety profiles with the goal of addressing the opioid crisis based on formulations utilizing micro-palmitoylethanolamide’s (“PEA”) “entourage” effect on
Under an exclusive worldwide license agreement, Fulcrum will develop and commercialize losmapimod, a potential disease-modifying therapy for facioscapulohumeral muscular dystrophy (FSHD). Fulcrum is planning to advance losmapimod into
Keytruda is an anti-PD-1 therapy, while Inlyta is a tyrosine kinase inhibitor. Keytruda will help enhance the ability of the body’s immune system to detect and combat tumor