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October 15, 2021

EMA Recommends VAXNEUVANCE Pneumococcal Vaccine for Approval EMA Recommends VAXNEUVANCE Pneumococcal Vaccine for Approval

The European Medicines Agency’s (EMA’s) human medicines committee has recommended approval for a pneumococcal vaccine in adults. The agency’s Committee for Medicinal Products for Human Use […]
October 15, 2021

EU Panel Likes Two Cancer Drugs, Drops One EU Panel Likes Two Cancer Drugs, Drops One

In Europe, two new cancer drugs have been recommended for approval, and one has had its marketing authorization withdrawn. The opinions were issued by the European […]
October 14, 2021

Lupin Recalls Irbesartan & Hydrochlorothiazide/Irbesartan Tablets Lupin Recalls Irbesartan & Hydrochlorothiazide/Irbesartan Tablets

Lupin Pharmaceuticals is recalling all batches of irbesartan tablets USP 75 mg, 150 mg, and 300 mg and irbesartan and hydrochlorothiazide (HCTZ) tablets USP 150 mg/12.5 […]
October 13, 2021

FDA Approves First-Line Pembrolizumab Plus Chemo for Cervical Cancer FDA Approves First-Line Pembrolizumab Plus Chemo for Cervical Cancer

The US Food and Drug Administration (FDA) has approved the checkpoint inhibitor pembrolizumab (Keytruda, Merck) alongside standard chemotherapy — with or without bevacizumab — as first-line therapy for patients with […]
October 13, 2021

New Approval in Early Breast Cancer: First Advance in 20 Years New Approval in Early Breast Cancer: First Advance in 20 Years

The CDK4/6 inhibitor abemaciclib (Verzenio) has been approved for use in early breast cancer for certain patients. One expert has described the drug as the first […]
October 13, 2021

US FDA Gives Marketing Nod to an e-Cigarette for the First Time US FDA Gives Marketing Nod to an e-Cigarette for the First Time

(Reuters) – The U.S. Food and Drug Administration (FDA) on Tuesday allowed British American Tobacco Plc (BAT) to market its Vuse Solo e-cigarettes and tobacco-flavored pods, […]
October 12, 2021

USPSTF Rules Out Aspirin for Over 60s in Primary CVD Prevention USPSTF Rules Out Aspirin for Over 60s in Primary CVD Prevention

New draft recommendations from the US Preventive Services Task Force (USPSTF) on the use of aspirin for the primary prevention of cardiovascular disease (CVD) have been […]
October 8, 2021

FDA Issues Warning About Use of Fillers With Needle-Free Devices FDA Issues Warning About Use of Fillers With Needle-Free Devices

The Food and Drug Administration issued a warning today about the use of needle-free devices for injecting dermal fillers — which are promoted to the public on social […]
October 8, 2021

FDA Approves Avacopan for Rare ANCA Autoimmune Disease FDA Approves Avacopan for Rare ANCA Autoimmune Disease

US regulators approved avacopan (Tavneos) for a rare immune disorder after receiving additional information to address concerns raised about the drug that were previously discussed at […]
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