Alembic receives USFDA final approval for Macitentan Tablets, 10 mg

Macitentan tablets are an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension

Novo Nordisk's Wegovy approved in the US for the treatment of MASH

The accelerated approval is supported by results from part 1 of the ESSENCE trial

FDA approves first immunotherapy for recurrent respiratory papillomatosis

Tonix receives FDA approval of Tonmya for treatment of fibromyalgia

From Policy to Practice: How India’s Pharmaceutical Industry is Being Shaped by the PLI Scheme – by Vikram Aditya Sehgal, Director – Finance, Centrient India

The PLI scheme focuses on incentivizing a strategic shift towards high-value, innovative products such as biologics, complex generics, and specialty formulations

FDA grants breakthrough therapy designation to Ifinatamab Deruxtecan for lung cancer patients

Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo

Xspray Pharma licenses patent rights to Handa Therapeutics, secures royalty agreement

Its lead product, Dasynoc, is awaiting FDA approval with a PDUFA date of October 7, 2025

AN2 Therapeutics begins first-in-human trial of oral AN2-502998 for chagas disease

Phase 1 dosing is expected to finish by the end of 2025

Enable injections receives enFuse system approval in Brazil and UK registration

AbbVie to invest $195 million to expand API manufacturing in North Chicago

The new facility will enhance AbbVie’s chemical synthesis capacity to support domestic production of current and next-generation neuroscience, immunology, and oncology medicines