Biocon and Carnegie receive FDA tentative approval for Rifaximin tablets

Rifaximin tablets are a rifamycin antibacterial indicated for reducing the risk of overt hepatic encephalopathy

Merck completes acquisition of Verona Pharma

Through this acquisition Merck has added Ohtuvayre (ensifentrine) to its growing cardio-pulmonary pipeline and portfolio

Health Secretary Srivastava chairs meeting with states/UTs on quality and rational use of cough syrups

States exhorted to ensure rational use of cough syrups, particularly among children, as most coughs are self-limiting and do not require pharmacological treatment

FDA supports new ANDA prioritization pilot to support US generic drugs

Roche’s AI-based kidney disease algorithm gains European certification

The new algorithm will be introduced as part of Roche’s CKD Algorithm Panelon thenavify Algorithm Suite

FDA approves Roche’s Tecentriq + lurbinectedin as first-line maintenance therapy for lung cancer

Combination reduced the risk of disease progression or death by 46% and risk of death by 27% in pivotal phase III IMforte study

Amgen’s Phase III data supports FDA label expansion of Repatha

Repatha is now the first and only PCSK9 inhibitor to demonstrate significant reduction of cardiovascular events as both primary and secondary prevention

AstraZeneca Pharma India receives sale, distribution approval from CDSCO for Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder

Trastuzumab Deruxtecan 100mg/5mL vial lyophilized powder for concentrate for solution for infusion is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors

FDA issues CRL for Sentynl’s copper histidinate for treatment of Menkes disease

IPA welcomes Dr. Sharvil Patel as President and Glenn Saldanha as Vice President