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USFDA approves expanded use of Bristol Myers immunotherapy for cancer

The approval marks the first-and-only immunotherapy-based treatment for use before surgery for non-small cell lung cancer

USFDA declines EUA nod to Covaxin

Despite receiving emergency use listing from the World Health Organization, Covaxin has not been cleared for any age group in the United States

Sanofi & GSK to seek USFDA & EMA approval for Covid-19...

When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralizing antibodies, with GMTs reaching 3711 units

Zydus posts consolidated revenues of Rs. 3655 crores in Q3

The company filed 12 additional ANDAs with the USFDA during the quarter and received 9 new product approvals (including 5 tentative approvals) from the USFDA.

Sun Pharma launches website for its long-term care portfolio in US

New website highlights the efficacy and safety profile for each product, while also educating healthcare providers and patients about our intent to mitigate risks associated with improper medication manipulation......................

Zydus Cadila’s Saroglitazar granted ‘Orphan Drug Designation’ by USFDA

Saroglitazar Mg is a potent and selective peroxisome proliferator-activated receptor alpha and gamma dual agonist used in the treatment of patients with Primary Biliary Cholangitis (PBC)........................

New technology allows control of gene therapy doses

Technique appears to solve a major safety issue and could lead to much more use of gene therapies.....................

Alvotech & Cipla Gulf join hands to commercialize key biosimilar in...

Under the partnership, Alvotech will be responsible for development and supply of AVT02, an adalimumab biosimilar, in select emerging markets., while Cipla Gulf will be responsible for registration and commercialization....................

Cost raising exercise via QCO won’t cover all aspects of patient...

Bureau of Indian Standards (BIS) through the Department of pharmaceuticals (DoP) is in the process of finalizing a quality control mechanism for medical devices...............

Lupin Bioresearch Centre completes fifth successful US-FDA inspection

Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune...................