Biocon Biologics has announced that its insulin manufacturing facility in Johor, Malaysia has been classified as an official action indicat...

"The USFDA has issued a CRL for the Biologics License Application (BLA) for Bevacizumab filed by our partner Viatris (Mylan)," a company sp...

The CRL cites additional data required in the BLA submission and an expectation of satisfactory implementation of a corrective and preventi...

The special CBI court, in an 80-page order rejecting the bail pleas of all five accused in the case earlier this week, said: "The questions...

A special court here had sent all the five accused, including a joint drug controller at Central Drugs Standard Control Organisation, to ju...

CBI has arrested five people including S Eswara Reddy, joint drug controller at CDSCO, L Praveen Kumar, associate vice president and head o...

The CBI has arrested Joint Drugs Controller S Eswara Reddy, Associate Vice President of Biocon Biologics L Praveen Kumar and three others i...

After completing the necessary paperwork, the CBI has arrested Reddy and Dua, nabbed during a trap operation on Monday while the alleged br...

Biocon's arm Biocon Biologics and Mylan, a subsidiary of Viatris Inc, have been informed by the USFDA of a deferred action on the BLA for M...

"To complete the application, the agency noted that an inspection of the manufacturing facility is required as a part of the standard revie...

Biocon and Mylan’s proposed biosimilar bevacizumab, a cancer drug, is expected to be the third biosimilar from the partnered portfolio for ...

This additional approval of its new manufacturing facility for pegfilgrastim in Bengaluru will enable the biotechnology major to enable its...

Biocon is confident of addressing these observations through a corrective and preventive action plan in a timely manner, it added.

The company said it does not expect the CRL to impact the timing of the launch of biosimilar Pegfilgrastim in the US market.

Biocon shares tanked 5.9 per cent to Rs 328.80 at the close on the BSE on Wednesday.

Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow- up inspection of t...

The company had posted a net profit after taxes, minority interest and share of profit from associates of Rs 104.1cr for the corresponding ...