On August 23, 2024, the FDA approved Amgen’s aflibercept biosimilar PAVBLU (aflibercept-ayyh), a biosimilar of Regeneron’s EYLEA®. According to the approval letter, “Pavblu is indicated for ...

The inspection, which took place between September 23 and September 27, 2024, concluded with 4 observations from the ...

Despite Biocon's assurances that the findings would not impact its business, investor sentiment appeared cautious.

Biocon shares fell 2% to Rs 361.5 after the USFDA issued four observations following an inspection of its Bengaluru API facility. The company will address these within the stipulated time and does not ...

Pharma company Biocon is set to announce its financial results for the quarter ended September 30, 2024, tomorrow, October 1 ...

Alembic Pharmaceuticals oral solid formulation facility (F-1) located in Panelav, Gujarat received establishment inspection report (EIR) from United States Food and Drug Administration (USFDA), which ...

Let's catch up on the latest news from the stock market. From significant investments to major deals, fund raising and ...

The scope of the inspection included one Drug Substance and one Drug Product manufacturing unit, a Medical Device Assembly ...

Biocon's Bengaluru API facility receives four observations from US FDA, company to address without business impact.

The US Food and Drug Administration (USFDA) conducted a surveillance inspection of the API facility (Site 2), located at ...

Biocon's Bengaluru-based API facility received four observations from the USFDA following an inspection. The company plans to ...