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FDA Authorizes Additional COVID-19 Combination Test Ahead of Flu Season
americanpharmaceuticalreview
July 15, 2020
The U.S. Food and Drug Administration (FDA) further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for ...
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FDA grants fast track status to Pfizer and BioNTech Covid-19 vaccines
pharmaceutical-technology
July 15, 2020
Pfizer and BioNTech have received fast track designation from the US Food and Drug Administration (FDA) for two of their four potential Covid-19 vaccines.
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US priority review for AZ' Brilinta/aspirin combination
pharmatimes
July 14, 2020
The US Food and Drug Administration has agreed to a speedy review of AstraZeneca's Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who have experienced an acute ischaemic stroke or transient ischaemic attack (TIA).
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FDA grants Fast Track designation to two COVID-19 vaccines
europeanpharmaceuticalreview
July 14, 2020
Two investigational SARS-CoV-2 vaccine candidates, BNT162b1 and BNT162b2, currently in clinical trials have been granted Fast Track designation by the FDA.
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Rhythm Receives Rare Pediatric Disease Designation for POMC, LEPR Deficiency Obesity Treatment
americanpharmaceuticalreview
July 13, 2020
Rhythm Pharmaceuticals announced the U.S. Food and Drug Administration (FDA) has granted rare pediatric disease designations for setmelanotide.
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FDA Approves Urothelial Carcinoma Maintenance Treatment
americanpharmaceuticalreview
July 13, 2020
The U.S. Food and Drug Administration (FDA) approved avelumab (BAVENCIO, EMD Serono) for maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) ...
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FDA Approves Expanded Use for BOTOX
contractpharma
July 13, 2020
For the treatment of spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy.
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Ardelyx Submits NDA for Tenapanor
americanpharmaceuticalreview
July 10, 2020
Ardelyx announced the submission of a New Drug Application (NDA) for tenapanor to the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
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Strides receives USFDA approval for headache drug
expresspharma
July 10, 2020
Butalbital, Acetaminophen, Caffeine, and Codeine Phosphate Capsules will be marketed by Strides Pharma in the US market.
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FDA Approves Home-Administered Breast Cancer Treatment
americanpharmaceuticalreview
July 09, 2020
The U.S. Food and Drug Administration (FDA) has approved Phesgo—a combination of pertuzumab, trastuzumab and hyaluronidase–zzxf—for injection under the skin to treat adult patients with HER2-positive breast cancer.