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1219 News Found

ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease
News | April 17, 2025

ACIP votes to expand recommendation for Pfizer’s RSV vaccine ABRYSVO to include adults aged 50 – 59 at increased risk of disease

Vote expands existing recommendation, which was for all adults aged 75 and older and high-risk adults aged 60 to 74


Lupin receives EIR from USFDA for its injectable facility in Nagpur
Drug Approval | April 17, 2025

Lupin receives EIR from USFDA for its injectable facility in Nagpur

The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024


Biocon Biologics secures market entry date for Yesafili in US
News | April 15, 2025

Biocon Biologics secures market entry date for Yesafili in US

YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions


Zyuds Lifesciences receives USFDA approval for DMD treatment drug
Drug Approval | April 14, 2025

Zyuds Lifesciences receives USFDA approval for DMD treatment drug

Deflazacort is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 5 years of age and older


Nureca’s manufacturing subsidiary secures USFDA registration
News | April 14, 2025

Nureca’s manufacturing subsidiary secures USFDA registration

This registration authorizes Nureca Technologies to continue manufacturing and exporting asuite of medical devices to the United States


Aurolife Pharma gets 11 observations from USFDA for Raleigh plant
Drug Approval | April 14, 2025

Aurolife Pharma gets 11 observations from USFDA for Raleigh plant

The company does not expect this development to have any material impact on the current business operations


FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer
Drug Approval | April 12, 2025

FDA approves Opdivo plus Yervoy as treatment metastatic colorectal cancer

The approval was granted more than two months ahead of the Prescription Drug User Fee Act goal date


Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension
Drug Approval | April 12, 2025

Cipla receives USFDA approval for Protein-bound Paclitaxel for Injectable Suspension

Protein-bound Paclitaxel is indicated for the treatment of metastatic breast cancer, locally advanced or metastatic non-small cell lung cancer and metastatic adenocarcinoma of the pancreas


Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab
Drug Approval | April 11, 2025

Biocon Biologics announces USFDA approval for Jobevne biosimilar Bevacizumab

Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis


Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s
Drug Approval | April 09, 2025

Shilpa’s Unit-2 passes second consecutive FDA inspection with no 483s

Raichur site is the group’s largest API facility and part of a wider network of seven sites