Biocon Usfda Approval

Biocon gets USFDA's tentative approval for antibacterial drug Rifaximin

The USFDA's tentative approval means Biocon Pharma's Rifaximin 550 mg meets regulatory requirements but cannot be marketed in the US yet due to patents or exclusivity on the original drug

Biocon share price rises 3% as arm gets USFDA nod for two drugs; details

By 10:35 AM, Biocon share price was trading 2.84 per cent higher at ₹364.45 per share. In comparison, BSE Sensex was trading 0.38 per cent higher at 83,004.53 levels.

Biocon Biologics secures USFDA approval for Bosaya and Aukelso biosimilars

Biocon Biologics gets USFDA approval for Bosaya and Aukelso, denosumab biosimilars of Prolia and Xgeva, with provisional interchangeability status to widen patient access

Stocks to Watch, April 28: RIL, M&M, Biocon, Shriram Finance, Tata Tech

Stocks to Watch on Monday: RIL, M&M, Biocon, Shriram Finance, Tata Tech, India Cements, IDFC First Bank and Zydus Lifesciences are among the stocks to watch today, April 28, 2025

Biocon Biologics gets US FDA nod for Jobevne, expands oncology portfolio

Jobevne works by blocking a protein called VEGF, which helps tumours grow new blood vessels

Biocon extends rally, up 6% in 2 days on HSBC, Motilal Oswal 'Buy' upgrade

Notably, Biocon share price has surged about 6 per cent in the last two sessions

USFDA approves Biocon Biologics' biosimilar for Crohn's disease, psoriasis

YESINTEK, a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis

Biocon subsidiary gets USFDA nod for generic drug for chronic heart failure

Biotechnology firm Biocon said its subsidiary has received approval from the US health regulator to market a generic medication to treat chronic heart failure. Biocon Pharma has received approval of its ANDA for Sacubitril/Valsartan Tablets, in 24 mg/26 mg, 49 mg/51 mg and 97 mg/103 mg strengths, from the US Food and Drug Administration (USFDA), the company said in a regulatory filing. Sacubitril and valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The medicine is also used to treat paediatric patients over the age of one year. The approval further adds to Biocon's portfolio of vertically integrated, complex drug products, the company said.

Biocon Biologics announces getting US FDA approval for eye treatment drug

Company says approval is a 'significant milestone' and marks entry in new therapeutic area in the US

Biocon leads India's push into anti-obesity drugs as patents lapse

The company, helmed by Kiran Mazumdar Shaw, is leading the charge among Indian drugmakers - the world's largest supplier of generic medicines - as they race to grab a slice of the obesity drugs market

In next 4-5 years, we aim capex of Rs 1,500 cr: Biocon's Siddharth Mittal

Siddharth Mittal outlines the growth strategies and challenges ahead

Biocon considers selling generic API biz; turn into biosimilar major

The generic API business has been one of the primary businesses for Biocon, however, in recent years, the segment's contribution towards the company's consolidated financials has declined

Official action indicated for Biocon arm's unit in Malaysia after FDA probe

Biocon Ltd on Wednesday said the US health regulator has classified as 'official action indicated' for the manufacturing facility of group firm Biocon Sdn Bhd at Johor, Malaysia following an inspection. The OAI (official action indicated) status may cause delay and/or withholding of pending product approvals or supplements from the facility, Biocon Ltd said in a regulatory filing. "Biocon Sdn Bhd, a step-down subsidiary of Biocon Biologics Ltd, has received a communication from the US Food and Drug Administration (FDA) pursuant to its July 2023 cGMP inspection at its insulins manufacturing facility at Johor, Malaysia," a company spokesperson said in the filing. The USFDA has "determined the inspection classification as 'OAI' (Official Action Indicated). The OAI status may cause delay and/or withholding of pending product approvals or supplements from the facility", the spokesperson added. As per the USFDA, OAI implies that the regulator may withhold approval of any pending product

Biocon slips 4% after USFDA asks for corrective measures at Malaysian unit

The USFDA has determined the inspection classification as 'OAI' (Official Action Indicated) post inspection of Biocon's step-down subsidiary in Malaysia.

Stride Pharma Global receives USFDA approval or Efavirenz, other drugs

The company aims to launch about 60 new products in the next three years in the US market

We're geared to launch a new molecule every 1-2 years: Biocon Biologics MD

In an interview, Arun Chandravarkar explains why a company must continue investing in R&D despite the impact on short-term Ebitda

Biotechnology major Biocon gets USFDA approval for generic product

The product is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant

Serum Alliance will give revenue stream from H2FY23: Biocon Biologics exec

In a Q&A, Shreehas Tambe talks about the road ahead for the firm's biosimilars business and how its alliance with Serum is projected to pan out

USFDA accepts Biocon-Mylan's Avastin biosimilar application for review

The application seeks approval of biosimilar bevacizumab for treatment of patients with metastatic colorectal cancer in addition to other ailments

USFDA approves production of Biocon biosimilar at new Bengaluru unit

The US Food and Drug Administration's (USFDA's) nod to Biocon's supplemental biologics licence application for the new unit will expand the company's capacity multifold, the company said