News | March 12, 2025
Poly Medicure receives MDR certification for 54 products
The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards
The MDR certification reafirms that these products meet the highest safety, quality, and regulatory standards
Overall investment in the US facility is estimated around US$50 million
The study demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics between YESINTEK and the reference product Stelara
ANVIMO will be available in dosages of 240 mg and 480 mg
Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA
YESINTEK is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis
Findings to form the basis for a Phase 3 program, anticipated to start in H2 2025
The inspection was successfully completed
YESINTEK, is intended for the treatment of adults and children with plaque psoriasis and adults with psoriatic arthritis or Crohn's disease
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
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