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Air bubbles in the monoblock oil of Philips Unity and BV Pulsera mobile C‑arm systems can cause X‑ray generation failure, displaying an error and requiring a restart.

Air bubbles in the monoblock oil of Philips Unity and BV Pulsera C‑arm units can cause flashovers, preventing X‑ray generation during early use after long storage.

The FDA granted approval for Apotex Inc.’s ANDA 076391, an inhalation solution of albuterol sulfate, with original approval in 2003 and a labeling supplement in 2017.

The FDA has approved ANDA078152 for prescription oral ondansetron tablets in 4 mg and 8 mg strengths, submitted by AvKARE, Glenmark and BluePoint.

The FDA has approved ANDA077849 for a fluoxetine oral solution (20 mg/5 mL) manufactured by Lannett Company, adding a new prescription product to the market.

FDA has approved Novitium Pharma's ANDA077550 covering discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) with original approval in 2015 and a labeling supplement in 2023.

The Korean MFDS revised its GIFT fast‑track guidelines, permitting patient‑reported symptoms, quality‑of‑life data, preferences, interviews, videos and written opinions as reference material for priority review of rare disease drugs.

Health Canada reports that Philips MR imaging systems running software versions R5 or R11 may freeze during image reconstruction if memory limits are exceeded, halting the exam.

Philips reports a software fault in MR systems (versions R5 & R11) that can freeze the system during image reconstruction, requiring a restart.

MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.

JW중외제약이 비만용 GLP‑1 ‘보팡글루타이드’의 2형 당뇨병 적응증을 위한 3상 임상 IND를 식품의약품안전처에 제출, 174명 대상 2024년 1월 시작 예정.

양천구약사회가 정부의 비대면진료 약배송 확대 방침이 기존 합의를 깨고 절차적 정당성이 부족하다고 비판했습니다.