Drug Approval | September 26, 2025
FDA approves Alembic’s Paroxetine ER tablets
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder
Paroxetine Extended-Release Tablets USP, 25 mg and 37.5 mg, are indicated for the treatment of major depressive disorder
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The association called for an end to the constant issuance of regulatory circulars that make operations unpredictable and capital-intensive.
Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality
Bictegravir, Emtricitabine, and Tenofovir Alafenamide Tablets are indicated for the treatment of human immunodeficiency virus infection in adults and pediatric patients weighing at least 25 kg
Alkem's Pertuza is an affordable, indigenously-developed and manufactured biosimilar of pertuzumab
The facility has been classified as Voluntary Action Indicated
Corning and SGD Pharma formed JV in June 2023 to expand pharmaceutical manufacturing in India
Collaboration combines Lunit's AI expertise with Agilent's diagnostic leadership to revolutionize biomarker testing and enhance precision medicine capabilities
Agency initiates safety label change and notifies physicians of possible link
All drug substance for Moderna’s authorized Spikevax (COVID-19 mRNA vaccine) targeting the SARS-CoV-2 LP.8.1 variant is produced at the company’s facility in Laval, Quebec
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