Viatris launches RYZUMVl 0.75% in US

The average time of dilation lasts three to eight hours

AstraZeneca and Daiichi Sankyo’s BLA for Dato-DXd accepted in the US for treatment of breast cancer

Application based on results from the TROPION-Breast01 Phase III trial

FDA Granted ODD to Utidelone Injectable from Biostar Pharma for treatment of breast cancer brain metastasis

Utidelone has the ability to cross BBB due to its unique physicochemical characteristic and insusceptibility to P-glycoprotein-mediated efflux

Krazati monotherapy shows significant survival benefit in KRAS G12C-mutated NSCLC Phase III Krystal -12 data

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 21, 2024

Briefs: Alkem Laboratories and Zydus Lifesciences

USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant

Biocon to obtain approval for diabetes drug, Liraglutide in UK

Liraglutide is a drug-device combination formulation used in the treatment of Type 2 Diabetes Mellitus

Warren Remedies commences commercial production of APIs

Briefs: Concord Biotech and Neuland Laboratories

The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483

Briefs: Zydus Lifesciences and Rainbow Children's Medicare

Zydus Lifesciences receives EIR report from USFDA for API Ahmedabad facility

Jagsonpal Pharmaceuticals launches QueeZy-ER

The product combines proven efficacy of Doxylamine succinate 20 mg and Pyridoxine hydrochloride 20 mg in an Extended Release formulation