The US Food and Drug Administration (FDA) approved AstraZeneca’s cancer drugs Imfinzi and Imjudo in combination with chemotherapy to treat patients with stage 4 non-small cell lung cancer. This approval is based on the phase 3 data published in September 2021. Imfinzi and Imjudo with chemotherapy have shown an overall 23 percent improvement in patients […]
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The US Food and Drug Administration’s (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has recommended AstraZeneca’s PT027 for the treatment of asthma in people aged 18 years and older. The Committee has voted 9 to 8 for adolescents aged 12 to 17 years, and the data do not support a favourable risk assessment for the use […]
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The US Food and Drug Administration (FDA) has approved Zydus Lifesciences’ hypertension drugs Bisoprolol Fumrate and Hydrochlorothiazide tablets in the United States. The US FDA has given clearance to Zydus Lifesciences to market generic medicines in the United States in multiple strengths. With increasing cases of hypertension, the combination of Bisoprolol Fumrate and hydrochlorothiazide is […]
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New Zealand’s The a2 Milk Company has received enforcement discretion from the US Food and Drug Administration to supply its a2 Platinum Premium Infant Milk Formula to the US market to help overcome the ongoing supply crisis. a2 Platinum is a leading international infant milk formula brand. The a2 Platinum is made with a2 milk, […]
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The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofivir alafenamide) 25 mg tablets by Gilead Sciences, Inc., to treat chronic hepatitis B virus (HBV) in pediatric patients older than 12 years with compensated liver disease. Vemlidy is a targeted, novel prodrug of tenofovir, which was previously […]
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The US Food and Drug Administration (FDA) has approved Johnson & Johnson’s new therapy to treat a type of multiple myeloma, and the therapy has given another option of treatment to patients suffering with incurable blood cancer. According to Johnson & Johnson, teclistamab therapy, which is branded as Tecvayli, is approved to treat adults with […]
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Zhiyi Biotech has announced that the US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application of the company to develop SK10 (Inactivated Bacteroids fragilis) for the treatment of Chemotherapy-induced Diarrhea (CID). The approval of the IND application authorizes Zhiyi Biotech to conduct a Phase 1 clinical trial in the United […]
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The US Food and Drug Administration (FDA) has authorized PADM Medical PRECISION ECO plant-based procedural mask with earloops under emergency use authorization (EUA). The face mask is the first plant based procedural mask in the world to receive EUA for use in medical and healthcare industries. PADM Medical Group of Companies, a global leader in […]
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The US Food and Drug Administration (FDA) of the United States has approved the on-body infusor ‘Furoscix’ for congestive heart failure developed by scpharmaceuticals. With this approval, Furoscix becomes the first self-administered, and subcutaneous loop diuretic for people with worsening heart failure. This infusor delivers generic furosemide that relieves fluid retention and swelling, which causes […]
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Eli Lilly and Company received Fast Track designation from the US Food and Drug Administration (FDA) for tirzepatide to treat adults with obesity or weight-related comorbidities. The US FDA grants Fast Track designation to facilitate development and expedite the review of medicines used for the treatment of serious conditions or diseases and to fulfil unmet […]
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