法规动态
FDA、EMA、TGA 及全球法规动态
法规动态
2026年8月27日•1 分钟阅读
WHO regrets US announcement to withdraw from organization
The World Health Organization expressed regret over the United States' announced intention to withdraw from the WHO.
法规动态
2026年8月27日•1 分钟阅读
GSK and Spero Therapeutics Secure FDA Approval for Oral Carbapenem Utebzi for cUTI
GSK and Spero Therapeutics received FDA approval for Utebzi, the first oral carbapenem antibiotic for complex urinary tract infections, including pyelonephritis.
法规动态
2026年8月27日•1 分钟阅读
FDA Approves ANDA077507 for Glipizide and Metformin Hydrochloride Tablets
The FDA has approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.
法规动态
2026年8月27日•1 分钟阅读
FDA Announces Discontinued Alprazolam Extended‑Release Tablets (ANDA 077198)
The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.
法规动态
2026年8月27日•1 分钟阅读
FDA Approves Atenolol (ANDA076900) Oral Tablets
The FDA has approved the ANDA076900 for Atenolol tablets (25 mg, 50 mg, 100 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.
法规动态
2026年8月27日•1 分钟阅读
FDA selects Lilly, Regeneron, Fujifilm and four others for PreCheck pilot
The FDA has chosen seven firms, including Eli Lilly, Regeneron and Fujifilm, to join its PreCheck Pilot Program aimed at bolstering U.S. drug manufacturing and supply‑chain resilience.
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法规动态
2026年8月27日•1 分钟阅读
Medical Journal Retracts Pivotal Study Data for Amgen’s Rare‑Disease Drug Tavneos
Amgen’s rare‑disease drug Tavneos faces added scrutiny after a leading medical journal retracted its pivotal study data, heightening FDA pressure.
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法规动态
2026年8月27日•1 分钟阅读
AstraZeneca to Pay $34M to Settle Texas Medicaid Kickback Lawsuit
AstraZeneca agreed to pay $34 million to resolve a lawsuit alleging illegal kickbacks to induce Medicaid prescriptions in Texas.
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法规动态
2026年8月27日•1 分钟阅读
FDA Approves Orca Bio’s Allogeneic Treg Cell Therapy Tregzi for Blood Cancer Transplants
Orca Bio received FDA approval for Tregzi, an allogeneic regulatory T‑cell therapy for blood‑cancer patients needing transplants.
法规动态
2026年8月26日•1 分钟阅读
Parliamentary Committee Formation May Impact Health Policy Amid Election Ballot Shortage
Lawmakers aim to resolve standing committee deadlock in the 22nd National Assembly's plenary session on June 18, with health and welfare committee composition under focus.
法规动态
2026年8月26日•1 分钟阅读
FDA Approves ANDA076620 for Fosinopril Sodium Tablets Submitted by Actavis Labs
The FDA granted approval for ANDA076620 on Oct 15, 2004, covering three oral fosinopril sodium tablet strengths submitted by Actavis Labs, all currently listed as discontinued.
法规动态
2026年8月26日•1 分钟阅读
FDA Approves Teva Torsemide Generic Tablets (ANDA 076346)
The FDA has approved Teva Pharmaceuticals’ ANDA 076346 for torsemide oral tablets in 5 mg, 10 mg, 20 mg and 100 mg strengths, prescription‑only.