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FDA Tightens Grip On Safe Weight Loss Drugs, WHO Adds Them To Essential Medicines List
07 Sep 2025 18:11 GMT
… appear to comply with the FDA standards.
APIs from other … S. are now pivoting to generics of Novo Nordisk‘s Wegovy … S. Food and Drug Administration (FDA), over 80 bipartisan members asked … lawmakers requested an update on FDA enforcement efforts by July 30 …
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Aquestive Therapeutics Announces that FDA Will Not Require an Advisory Committee Meeting to Discuss New Drug Application for Anaphylm™
04 Sep 2025 11:00 GMT
… caregivers, and patients following FDA approval.” Anaphylaxis is a … process through the FDA of our product candidates … pharmacodynamic comparability submission for FDA approval of Anaphylm; … any competing products, including generics; risk associated with …
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Flexible Approaches Needed for GLP-1 Coverage Decisions | PBMI 2025
05 Sep 2025 00:08 GMT
… as manufacturers achieved FDA approval for weight … kidney disease. The FDA initially approved Wegovy … generics and new products become available and increase competition. Recently Teva Pharmaceuticals … has received FDA approval and …
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World Sexual Health Day 2025: Advancing Global Awareness and Prevention
04 Sep 2025 13:17 GMT
… complementing its March 2025 FDA approval for uncomplicated urinary … concerns identified. Doravirine, already FDA approved as Pifeltro, is … twice yearly, recently received FDA approval based on phase … access gaps until licensed generics are available, with the …
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FTC and DOJ hear from experts on how to increase competition and promote affordability in the U.S. pharmaceutical industry
04 Sep 2025 22:09 GMT
… distinction between biosimilar and interchangeable FDA designations. Thomas DeMatteo, Chief … ensure fair procurement reimbursement for generics. She also suggested designing programs … target the alleged withholding by drug companies of information from the U …
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Generic competition shouldn’t come at the expense of patient safety
08 Sep 2025 23:26 GMT
… . prescriptions are filled with generics. That overwhelming share saves … generics are world-leading in affordability, access, and quality.
But the FDA … development.
For decades, the FDA has insisted that aluminum … . When combined, the FDA’s calculations don’t …
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Can CDMOs keep up with the increasing demand for GLP-1 medications?
08 Sep 2025 18:29 GMT
… meantime, Lupin in July received FDA approval for its Abbreviated New … for companies in the Chinese generics market, according to data and …
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Superbugs are rising. India’s scientists are fighting back
08 Sep 2025 12:03 GMT
… US Food and Drug Administration (FDA). Drugmaker Wockhardt has over five … the drug to get US FDA approved.
During this time, the … Indian pharma giant in the generics space, had big ambitions. “Why … . In 2013-14, the US FDA imposed import alerts on two …
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Zydus Lifesciences shares in focus on licensing deal with Synthon for generic ZEPOSIA in US market
05 Sep 2025 05:00 GMT
… the company’s U.S. generics portfolio.
Under the terms, … from the U.S. FDA within 30 months of filing … integrated global leader in complex generics, with operations across eight countries … , President and CEO of Zydus Pharmaceuticals (USA).
Also read: You …
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AAM releases 2025 U.S. Generic & Biosimilar Medicines Savings Report
04 Sep 2025 20:13 GMT
… the overall healthcare system. Generics and biosimilars have saved over … and CEO of AAM. “Generics and biosimilars are the only … market. Policymakers must streamline FDA processes, curb patent abuse … generic and biosimilar medicines generics made up 90% of …