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Bengaluru: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Health ...Read More >
Stocktwits - Indian equity markets took a breather, snapping a four-day winning streak, with the Nifty index ending above the 25,500 level. The Sensex fell 452 points to close at 83,606, while the Nifty 50 fell 120 points to finish at 25,517. Broader markets outperformed with the Nifty Midcap index gaining for the seventh straight session. The Midcap and Smallcap indices rose by over 0.5%. The retail investor sentiment surrounding the Nifty 50 remained 'bullish' on Stocktwits. Nifty sentimen ...Read More >
New Delhi, Jun 30 (PTI) Alembic Pharmaceuticals on Monday said it has received the final approval from the US health regulator for its generic Doxorubicin Hydrochloride Liposome injection in different types of cancer. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) is for Doxorubicin Hydrochloride Liposome injection of strengths 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) single-dose vials, Alembic Pharmaceuticals said in a statement ...Read More >
New Delhi: Drugmaker Wockhardt said its novel antibiotic Zaynich has an addressable market opportunity of $7 billion in the US and Europe. The company said it has completed a pre-NDA (non-disclosure agreement) meeting with the US Food and Drug Administration (USFDA) in May 2025. Filing to the USFDA is slated in the second quarter of the current fiscal with potential launch in FY2026-27, Wockhardt Ltd said in a regulatory filing. The company plans for regulatory approval for the product in Europ ...Read More >
The Maharashtra Food and Drug Administration (FDA) has suspended the food business licence of Kiranakart Technologies Pvt Ltd's Dharavi distribution outlet -- a key supply node for quick-commerce platform Zepto -- after an inspection revealed serious breaches of food safety regulations. The inspection, conducted on Saturday by Food Safety Officer Ram Bodke, was initiated at the directive of Yogesh Kadam, Minister of State for FDA, and supervised by Joint Commissioner Mangesh Mane. The findings ...Read More >
New Delhi, Dec 17 (PTI) Drug firm Granules India on Tuesday said its subsidiary has received approval from the US health regulator for a generic medication used to treat attention-deficit hyperactivity disorder. Granules Pharmaceuticals, Inc (GPI) has received approval from the US Food & Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Lisdexamfetamine Dimesylate chewable tablets, the drug firm said in a statement. The approved drug is available in multiple stren ...Read More >
Granules India shares slipped sharply in trade, down nearly 10% after the company informed that US FDA has classified the inspection at Gagillapur facility in Hyderabad, Telangana as an 'Official Action Indicated' (OAI). The exchanges were informed about an inspection at the facility on September 7, which had resulted in a Form 483 issuance with six observations. Now, Granules India has said that it has responded to 'all the observations' issued by the USFDA. "The Company has responded to all ...Read More >
AstraZeneca is benefiting from surging demand for cancer treatments like Imfinzi and Calquence, and has a robust pipeline expected to deliver two dozen new products by 2030. Leading vaccine makers like Eli Lilly (NYSE:LLY), Pfizer (NYSE:PFE), and AstraZeneca NASDAQ:AZN) may have faded from the spotlight since the peak of the COVID-19 pandemic, but now there is reason to expect renewed interest. As investors look ahead to the second Trump administration, the incoming president's nomination of ...Read More >
First & only immuno-oncology drug approved by various regulatory authorities around the world Dr. Reddy's Laboratories has announced the launch of Toripalimab in India. Toripalimab is a New Biological Entity (NBE). It is the only immuno-oncology drug approved by various regulatory authorities around the world such as United States Food and Drug Administration (USFDA), European Medicines Agency (EMA), Medicines and Healthcare products Regulatory Agency (MHRA), and others for the treatment of adu ...Read More >
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