Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad

Biocon Biologics appoints Deepali Naair as Global Head - Brand & Corporate Communications

She was Group Chief Marketing Officer at CKA Birla Group in her last role

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths

Miltenyi Biotec and THSTI partner to launch CAR-T Cell and gene therapy training curriculum

This collaboration aims to bridge India’s talent and translational gap in this rapidly growing field by equipping professionals with practical expertise in the manufacturing of advanced therapies.

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