FDA accepts Wockhardt's NDA for breakthrough antibiotic Zaynich

This is the first time in history that an NDA for a New Chemical Entity (NCE) from an Indian pharmaceutical company has been filed and accepted by the USFDA

Bayer welcomes US Solicitor General’s support as Supreme Court weighs Roundup case

At the heart of the showdown is a deep split among federal circuit courts over whether federal law overrides state failure-to-warn claims in Roundup personal-injury suits

OSR Holdings moves towards major licensing deal for oral cancer immunotherapy

Under the proposed terms, Vaximm would secure a $20 million upfront payment, up to $815 million tied to clinical, regulatory, and commercial milestones

Lupin receives FDA approval for biosimilar Armlupeg

Armlupeg is indicated for decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs

Lung Cancer Canada and Boehringer Ingelheim team up to transform lung cancer detection

Selected proposals in the innovation challenge will receive funding to develop transformative ideas, tools, and approaches to strengthen early diagnosis and improve patient outcomes

SAI Parenteral's acquires Australia's Noumed Pharmaceuticals for Rs. 125 Cr

MHRA clears inavolisib, offering new option for returning breast cancer

The oral, film-coated tablet is licensed for patients whose cancer has returned during or shortly after hormone therapy

Innoxel Lifesciences completes EU GMP inspection by Belgium's FAMHP

The audit was completed with zero critical and zero major observations

Piramal Pharma Solutions achieves global nitrosamine compliance, strengthening patient safety

Nitrosamines have prompted evolving global guidelines that demand rigorous industry oversight

Novo Nordisk fast-tracks higher-dose obesity drug to FDA

The drug, intended for chronic weight management alongside diet and exercise, is now under the FDA’s new CNPV expedited review pathway