Actualizaciones regulatorias

The World Health Organization expressed regret over the United States' announced intention to withdraw from the WHO.

GSK and Spero Therapeutics received FDA approval for Utebzi, the first oral carbapenem antibiotic for complex urinary tract infections, including pyelonephritis.

The FDA has approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.

The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.

The FDA has approved the ANDA076900 for Atenolol tablets (25 mg, 50 mg, 100 mg) manufactured by Zydus Lifesciences and Zydus Pharmaceuticals USA.

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.

Amgen’s rare‑disease drug Tavneos faces added scrutiny after a leading medical journal retracted its pivotal study data, heightening FDA pressure.

AstraZeneca agreed to pay $34 million to resolve a lawsuit alleging illegal kickbacks to induce Medicaid prescriptions in Texas.

Orca Bio received FDA approval for Tregzi, an allogeneic regulatory T‑cell therapy for blood‑cancer patients needing transplants.

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.

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.

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.