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Preparing for FDA Remote Inspections: What to Expect for 2022

If there’s one thing 2020 taught the world, it’s that the road ahead is ever-changing. Given the Delta variant on the rise and the significant …

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Current Features

It’s Now Time for Your OPDP Submissions to be FDA Compliant | Are You Ready?

The Prescribing Information, Labeling, and any other materials used for the promotion of Drug Products for their approved indication, or intended purpose of use, are …

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FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer

The US Food and Drug Administration (FDA) has approved Exelixis’ Cabometyx (cabozantinib) for the treatment of patients with previously treated radioactive iodine-refractory differentiated thyroid cancer …

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FDA approves first COVID-19 vaccine

The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be …

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FDA approval for Xywav for idiopathic hypersomnia in adults

Jazz Pharmaceutical’s Xywav (calcium, magnesium, potassium, and sodium oxybates) oral solution for the treatment of idiopathic hypersomnia in adults has been granted US Food and …

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FDA approves Keytruda plus Lenvima for advanced kidney cancer

The US Food and Drug Administration (FDA) has approved a combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) plus Eisai’s Lenvima (lenvatinib) for the first-line treatment …

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US rejects AZ and FibroGen’s anaemia drug roxadustat

The US Food and Drug Administration (US) has handed AstraZeneca a complete response letter (CRL) regarding its anaemia drug roxadustat. AZ had submitted a new …

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FDA approves magnetic device system for guiding sentinel lymph node biopsies in certain patients with breast cancer

The U.S. Food and Drug Administration today approved a magnetic device system for guiding lymph node biopsies in patients with breast cancer undergoing mastectomy. The …

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WuXi STA’s Jinshan Site Passes Fourth U.S. FDA Inspection

 STA Pharmaceutical Co., Ltd., (WuXi STA), a subsidiary of WuXi AppTec, announces that its Active Pharmaceutical Ingredient (API) manufacturing facility at Jinshan (Shanghai, China) has successfully …

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FDA Grants QIDP Designation to Acurx's Lead Antibiotic Product Candidate, ACX-362E for Clostridium Difficile Infection

Acurx Pharmaceuticals, LLC (“Acurx” or the “Company”), a privately held clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections, today …

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