Drug Approval | May 14, 2025
Briefs: Zydus and CuraTeQ Biologics
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
CuraTeQ Biologics receives approval for biosimilar Zefylti from UK’s MHRA
Haloperidol Decanoate Injection indicated for the treatment of patients with schizophrenia who require prolonged parenteral antipsychotic therapy
The Protect VL project was born out of a vision to reduce the environmental footprint of medical devices
Tolvaptan Tablets are indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease
Glatiramer Acetate is the generic version of Copaxone 20 mg/ml, 40 mg/ml, Single-Dose Prefilled Syringes
Lupin is one of the first ANDA applicants and is eligible for 180 days of shared generic exclusivity
The CEP certification for Metformin Hydrochloride aligns with the company's strategy to penetrate stringently regulated markets
Gelhaus has a proven track record of driving business growth
he inspection covering the sterile drug product filling and packaging line, quality systems and quality control laboratories concluded compliance with the principles and guidelines of Good Manufacturing Practice
IGI recently completed the dose-escalation portion of its Phase 1 clinical study in patients with heavily pretreated multiple myeloma
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