Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)

Biogen to invest $2 billion to expand manufacturing capability in North Carolina

Investment builds on Biogen’s 30-year history of manufacturing in the region, with approximately $10 billion invested to date

Roche updates on sBLA for Columvi combination for people with relapsed or refractory diffuse large B-cell lymphoma

Based on the CRL, the STARGLO data do not provide sufficient evidence to support the proposed second-line DLBCL indication in the US patient population

AstraZeneca’s Tagrisso plus chemotherapy improves overall survival in EGFR-mutated advanced lung cancer

Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination

Lupin achieves GMP certification from TGA Australia for Dabhasa API facility

Kenvue collaborates with API to launch India’s first cough clinics

Aims to support healthcare practitioners with evidence-based cough categorization tools that enable choosing the right molecules for effective & targeted relief from cough

Concord Biotech announces successful completion EU GMP inspection at its API facility

This achievement underscores our unwavering commitment to upholding the highest standards of quality, safety, and regulatory compliance

Biocon Biologics expands diabetes portfolio with FDA approval of Kirsty

SMS Lifesciences India receives EIR with VAI status from USFDA for API facility at Kazipally

The receipt of EIR reaffirms the company's commitment to maintaining global quality standards

Capricor receives FDA’s CRL for Deramiocel BLA for duchenne muscular dystrophy

Capricor’s BLA for Deramiocel received Priority Review in March 2025