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October 19, 2021

FDA Approves Combo Pill for Severe, Acute Pain FDA Approves Combo Pill for Severe, Acute Pain

The US Food and Drug Administration (FDA) has approved a combination pill containing celecoxib and tramadol (Seglentis) for the treatment of adults with acute pain severe […]
October 18, 2021

FDA OKs New High-Dose Naloxone Product for Opioid Overdose FDA OKs New High-Dose Naloxone Product for Opioid Overdose

The US Food and Drug Administration (FDA) has approved a high-dose naloxone injection product for the emergency treatment of opioid overdose. ZIMHI from Adamis Pharmaceuticals is […]
October 18, 2021

FDA Expands Use of HIV Drug to Young Children FDA Expands Use of HIV Drug to Young Children

The US Food and Drug Administration (FDA) has approved an expanded indication of the antiretroviral medication Biktarvy for younger children living with HIV. The new lower […]
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In Europe, two new cancer drugs have been recommended for approval, and one has had its marketing authorization withdrawn.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, […]
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