Alvotech and Dr. Reddy’s Announce FDA Acceptance of Biologic License Application for AVT03, a Proposed Biosimilar to Prolia® and Xgeva®
Dr. Reddy's Laboratories Ltd (RDY)
US:NYSE Investor Relations:
drreddys.com/investors
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Source: Business Wire
HYDERABAD, India & REYKJAVIK, Iceland--(BUSINESS WIRE)--Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY; along with its subsidiaries together referred to as “Dr. Reddy’s”) and Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has accepted a 351(k) Biologic License Application (BLA) submission for AVT03, developed by Alvotech, a proposed biosimilar of Prolia® (denosumab) and Xgeva® (denosumab).“The FDA's filing acceptance of Dr. Reddy's proposed denosumab biosimilar marks an important milestone in bringing this bi
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- Henlius 2024 Annual Results: Steady Revenue Growth with a Net Profit of RMB820.5 million, Up by 50.3% YoY [Yahoo! Finance]Yahoo! Finance
- Alvotech and Dr. Reddy's gets FDA nod for Biologic License Application for AVT03 [Seeking Alpha]Seeking Alpha
- Dr. Reddy's Issues a Nationwide Recall of Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL, in the U.S., due to Mislabeling of Infusion BagBusiness Wire
RDY
Earnings
- 1/24/25 - Beat
RDY
Sec Filings
- 3/24/25 - Form 6-K
- 3/21/25 - Form 6-K
- 3/13/25 - Form 6-K
- RDY's page on the SEC website