The US Food and Drug Administration (FDA) of the United States, AstraZeneca’s Evusheld is proving ineffective against Omicron COVID-19 variants. Amid new reports, the antibody combination is ineffective against the latest subvariant of Omicron COVID-19 variants, including BA.4.6. The US FDA said that it can increase the risk of COVID-19 infection for the variants that […]
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Kite, a Gilead Company, announced the retroviral vector (RVV) manufacturing facility of the company in California, has received the US Food and Drug Administration (FDA) approval for commercial production. Viral vectors are important components needed to manufactures cell therapies of Kite to treat certain types of blood cancers. Kite is the only cell therapy company […]
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Bubs Australia Ltd., a baby formula producer, is seeking permanent access to the United States market after the US Food and Drug Administration (FDA) revealed how companies that have been filling a temporary shortage can become long-term suppliers of baby formula. Bubs Australia has lodged a letter of intent with the US FDA for permanent […]
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The US Food and Drug Administration (FDA) has approved IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% for ocular surface anesthesia by applying it topically to the area. The safety and efficacy of IHEEZO were demonstrated in three human clinical studies. The first two studies were randomized, placebo-controlled, and double-blinded and evaluated the effect of IHEEZO on […]
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GE Healthcare announced that the US Food and Drug Administration (FDA) has cleared its AIR Recon DL for 3D and PROPELLER imaging sequences. The advantages of AIR Recon DL are extended by the new features to cover all Magnetic Resonance Imaging (MRI) clinical procedures, which covers all anatomies and enables better image quality, enhanced patient […]
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Pharming Group N.V., announced that it has got acceptance from the US Food and Drug Administration (FDA) for priority review of Pharming’s New Drug Application (NDA) for leniolisib, an oral and selective phosphoinositide 3-kinase delta inhibitor. The inhibitor is used to treat the rare primary immunodeficiency activated phosphoinositide 3-kinase delta syndrome (APDS) in adults and […]
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The US Food and Drug Administration (FDA) has approved omidenepag isopropyl ophthalmic solution (OMLONTI) 0.002% eye drops for treating the elevated intraocular pressure (IOP) in patients with primary glaucoma. OMLONTI 0.002%, is a selective prostaglandin E2 receptor agonist that is indicated for the reduction of elevated intraocular pressure (IOP) in patients with ocular hypertension or […]
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Pfizer and its German partner BioNTech are asking the US Food and Drug Administration (FDA) to approve the new COVID-19 booster vaccine shots targeting the Omicron variant for school-age children. Pfizer and BioNTech submitted an application for emergency use authorization of their BA.4 and BA.5 focused bivalent vaccines for children between 5 to 11 years […]
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The US Food and Drug Administration (FDA) staff has raised concerns over the safety of an experimental cancer drug by Spectrum Pharmaceutical and also questioned the benefits the drug provided over existing therapies. The concerns over the cancer drug poziotinib were raised in the US FDA’s briefing documents ahead of a meeting of the regulator’s […]
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The US Food and Drug Administration (FDA) has approved intravenous therapy of Fennec Pharmaceuticals Inc. to prevent chemotherapy-induced hearing loss in children. The new therapy is called Pedmark. The approval, posted on the website of the US FDA, allows it to be used to decrease the risk of ototoxicity in children aged over one month […]
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