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

Pi Health to deliver clinical research services for GSK’s Phase 2 oncology trial

Physician-led Pi Health has demonstrated capabilities to dramatically reduce clinical trial timelines and administrative burden, while increasing data quality

Croda expanded UK facility, invests in biopharma innovation

The expansion, supported by a significant UK government grant, includes a new lipid system synthesis facility and enhanced R&D capabilities

AstraZeneca’s Koselugo recommended for approval in the EU for Neurofibromatosis type 1

The positive opinion is based on results from KOMET, the largest and only placebo-controlled, double-blind global Phase III trial in this patient population

Zydus receives EIR for oncology injectable manufacturing facility in Ahmedabad SEZ1

The facility has been classified as Voluntary Action Indicated

Glenmark signs cancer drug licensing deal with Hengrui Pharma for $18 million upfront payment

Hengrui is eligible to receive regulatory and commercial milestone payments of up to US$1.093 billion

FDA responds to evidence of possible association between autism and acetaminophen use during pregnancy

Agency initiates safety label change and notifies physicians of possible link

Briefs: Relonchem, Patel Chem Specialities and J & H Pharma Consultants

Relonchem receives marketing authorization for Moxonidine tablets

Zydus, Pinkathon to drive awareness on breast cancer across India

Zydus Pinkathon will be led by women to raise awareness on breast cancer and women's health

Shilpa Medicare receives initial authorization for Rivaroxaban Orodispersible films from EMA