Caplin Point receives EIR from FDA with Zero 483 observations

The inspection, which is a routine part of the FDA's regulatory oversight, evaluates compliance with Good Manufacturing Practices and other regulatory requirements.

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A

Sumitomo Pharma America receives USFDA approval of vibegron for benign prostatic hyperplasia

GEMTESA is the first and only beta-3 agonist approved for the treatment of men with OAB symptoms who are receiving pharmacological therapy for BPH

USFDA accepts Blenrep combinations for treatment of relapsed/refractory multiple myeloma

If approved, Blenrep (belantamab mafodotin) in combinations with BorDex (BVd) and PomDex (BPd) could redefine multiple myeloma treatment at or after first relapse

Shilpa Medicare’s acceptance by USFDA of NDA filed by its CDMO partner Unicycive for Oxylanthanum Carbonate

Briefs: Lupin, Alembic Pharmaceuticals and Piramal Pharma

Lupin's Pithampur Unit-1 gets Form 483 from USFDA with 3 observations

Sanofi’s dupixent approved in the US as the first-ever biologic medicine for patients with COPD

Dupixent is indicated for the approximately 300,000 adults in the US with inadequately controlled COPD and an eosinophilic phenotype

Briefs: Biocon, Aarti Drugs and Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Limited has informed that the USFDA has issued Form 483 with zero observations

Fasenra approved in the US for eosinophilic granulomatosis with polyangiitis

New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids

USFDA concludes audit for Laurus Labs’ API manufacturing facility at Hyderabad with zero Form 483 observations

The USFDA inspection focused on evaluating the facility's adherence to global regulatory requirements and best practices