Zydus receives tentative approval from USFDA for Ibrutinib tablets

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

NATCO Pharma API unit in Mekaguda receives EIR from USFDA

The company received one observation in the Form-483

Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products

Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India

Akums launches high-strength Paracetamol oral suspension 500mg/5ml

Akums bridges the long-standing gap between paediatric syrups and conventional tablet formats

AstraZeneca plans to invest $50 billion in US by 2030

Investment will support AstraZeneca’s ambition to reach $80 billion revenue by 2030, with 50% generated in the US

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

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

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

Lupin receives Form 483 with 4 observations from USFDA for Pithampur unit-2

The company is addressing these observations comprehensively