Alembic Pharma receives USFDA tentative approval for Binimetinib tablets

Company becomes sole first applicant for 45 mg strength, positioning itself for potential 180-day generic exclusivity in the US market

Dr Reddy’s launches first-to-market generic Bosutinib in US oncology push

Dr Reddy’s has partnered with MSN Laboratories Private Limited on the product, with Dr Reddy’s holding exclusive US marketing rights while MSN leads development and manufacturing

Alembic Pharma receives USFDA tentative approval for generic Larotrectinib capsules

Company may qualify for 180-day generic exclusivity as sole first applicant for Bayer’s Vitrakvi capsules in the U.S.

Lupin secures U.S. FDA approval for interchangeable biosimilar Ranibizumab

Ranluspec is the only interchangeable ranibizumab biosimilar approved in the United States in both vial and pre-filled syringe (PFS) presentations

Aurobindo Pharma receives USFDA nod for generic Tofacitinib tablets

Approval for generic version of Xeljanz enables immediate launch and strengthens Aurobindo’s U.S. portfolio with its 586th ANDA approval

Roche’s MS drug fenebrutinib delivers striking Phase III results by cutting relapse rates by 58%

The company announced that its Phase III FENhance 1 and 2 studies both met their primary endpoints

Nuvation Bio secures global rights to promising brain tumor drug Safusidenib, expands Phase 3 study to Japan

Cipla strengthens US respiratory portfolio with final FDA nod for generic Nintedanib

ANDA approval for 100 mg and 150 mg capsules targeting idiopathic pulmonary fibrosis opens access to a $3.76 billion market in USA

Roche’s Fenebrutinib moves closer to being first BTK inhibitor for relapsing and progressive MS

Fenebrutinib has the potential to become the first and only high-efficacy oral, brain-penetrant treatment for both RMS and PPMS, showing a profound benefit on relapsing and progressive disease biology

Novartis’ remibrutinib bags positive CHMP opinion for chronic urticaria

The oral therapy is aimed at adults with chronic spontaneous urticaria (CSU) who do not respond adequately to H1-antihistamines