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Diễn biến quy định từ FDA, EMA, TGA và các cơ quan toàn cầu
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24 thg 8, 2026•1 phút đọc
MHRA Removes Post‑Operative Pain Indication for All Prolonged‑Release Opioids
The MHRA has withdrawn the licence indication for post‑operative pain from all prolonged‑release opioids, citing heightened risk of persistent use and opioid‑induced respiratory complications.
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24 thg 8, 2026•1 phút đọc
MHRA Issues New Recommendations for Fezolinetant to Mitigate Liver Injury Risk
MHRA warns that fezolinetant can cause drug‑induced liver injury and advises liver function monitoring before and during treatment.
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24 thg 8, 2026•1 phút đọc
FDA Recall: Incorrect Expiration Date on Product Bottles
The FDA has issued a recall for bottles labeled with an incorrect expiry date of 11/2016; the correct date should be 09/2016.
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24 thg 8, 2026•1 phút đọc
FDA Recalls Sterile Injectable Drugs Due to Glass Particulate Contamination
The FDA has issued a recall for sterile injectable drugs after detecting glass particulate contamination in the active pharmaceutical ingredient.
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24 thg 8, 2026•1 phút đọc
FDA Recalls Products Due to Contaminated Excipient from Supplier
The FDA has issued a recall for products manufactured with a contaminated excipient that was previously recalled by the supplier, citing CGMP deviations.
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24 thg 8, 2026•1 phút đọc
Spero Therapeutics and GSK Advance Utebzi Toward FDA Approval
Four years after a FDA rejection, Spero Therapeutics and GSK have moved their oral UTI drug Utebzi closer to approval.
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24 thg 8, 2026•1 phút đọc
Korean Government Reaffirms Separate Payment Policy for Specimen Tests
Amid medical sector backlash, the Ministry of Health and Welfare reiterates its plan to implement separate payments for specimen testing and pursue spending efficiency measures.
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24 thg 8, 2026•1 phút đọc
South Korea proposes amendment to ban promotional sales by telemedicine platforms
A medical law amendment introduced by lawmaker Lee Hoon-gi aims to prohibit telemedicine intermediaries from selling drugs and conducting promotional activities, ensuring neutrality in drug distribution.
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24 thg 8, 2026•1 phút đọc
FDA Approves LIDOCAINE AND PRILOCAINE Topical Cream (ANDA076320)
The FDA approved ANDA076320 for a prescription topical cream containing 2.5% lidocaine and 2.5% prilocaine, manufactured by Encube Ethicals.
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24 thg 8, 2026•1 phút đọc
Hikma Pharm's Rosiglitazone Maleate Tablet ANDA Receives Tentative Approval (ANDA078658)
FDA granted tentative approval to Hikma Pharm's ANDA078658 for three oral rosiglitazone maleate tablet strengths (2 mg, 4 mg, 8 mg).
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24 thg 8, 2026•1 phút đọc
FDA Approves Dr. Reddy's DESLORATADINE Oral Disintegrating Tablets (ANDA 078367)
The FDA has approved Dr. Reddy's Laboratories' DESLORATADINE oral disintegrating tablets in 2.5 mg and 5 mg strengths under ANDA 078367.
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24 thg 8, 2026•1 phút đọc
MHRA warns of severe asthma risk from overuse of short‑acting β2‑agonists
The MHRA reminds healthcare professionals and patients that overusing short‑acting β2‑agonists can trigger severe asthma attacks and increase mortality, even with maintenance therapy.