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News about "US Food and Drug Administration "
US Food and Drug Administration to Drop Two-Study Requirement for New Drug Approvals
The US Food and Drug Administration has announced plans to eliminate its long-standing expectation that new medicines be supported by at least two pivotal clinical trials, signaling a significant shift in regulatory policy aimed at accelerating patient access to innovative therapies.
US Food And Drug Administration | 19/02/2026 | By Darshana
FDA Approves Tenpoint Therapeutics' Yuvezzi, First Dual-Action Eye Drop for Presbyopia
The US FDA has approved Yuvezzi (carbachol and brimonidine tartrate), the first dual-agent eye drop for presbyopia, offering significant near-vision improvement with favourable tolerability.
US Food And Drug Administration | 31/01/2026 | By News Bureau | 209
SN Bioscience's SNB-101 Secures FDA Orphan Drug Designation for Gastric Cancer
SNB-101 is a polymer nanoparticle–based anticancer drug that uses SN-38, a highly potent but extremely insoluble active pharmaceutical ingredient.
US Food And Drug Administration | 29/12/2025 | By Abha | 116
Beckman Coulter Launches RUO Immunoassay Test
Access BD-Tau, along with Beckman Coulter Diagnostics's expanding portfolio of neuro-degenerative disease RUO assays, is available for use on the ground-breaking DxI 9000 Immunoassay Analyzer and Access 2 Analyzer.
US Food And Drug Administration | 12/09/2025 | By Dineshwori | 160
Gland Pharma Secures USFDA Approval for Ready-to-Use Vasopressin Injection
The product is bioequivalent and therapeutically equivalent to the reference drug Vasostrict. Vasopressin is indicated for adults with vasodilatory shock who remain hypotensive despite adequate fluid resuscitation and catecholamine support.
US Food And Drug Administration | 27/08/2025 | By Darshana | 134
Extrovis AG, Dr. Reddy's Partner to Roll Out CARAC 0.5 Percent Generic in US Market
Extrovis AG and Dr. Reddy's Laboratories have announced the launch of Fluorouracil Cream, 0.5 percent, an authorised generic and therapeutic equivalent of Carac (fluorouracil cream) 0.5 percent, in the US market.
US Food And Drug Administration | 19/08/2025 | By Dineshwori | 227
Governor of New York State Kathy Hochul has announced that Garonit Pharmaceutical, a global manufacturer of antiseptic products and health care solutions, will establish a state-of-the-art, 200,000-square-foot pharmaceutical manufacturing facility in New Windsor, Orange County.
US Food And Drug Administration | 05/08/2025 | By Dineshwori | 264
Moderna Sees 41 Percent Q2 Revenue Drop as COVID Vaccine Sales Decline
Moderna posted USD 142 million in revenue for the second quarter 2025, down 41 percent from USD 241 million in the same period last year.
US Food And Drug Administration | 04/08/2025 | By Dineshwori | 229
FDA Appoints Dr. George F Tidmarsh as Director of Center for Drug Evaluation and Research
The US Food and Drug Administration (FDA) has appointed Stanford faculty member Dr. George Francis Tidmarsh as the new Director of the Center for Drug Evaluation and Research (CDER).
US Food And Drug Administration | 21/07/2025 | By Dineshwori | 460
FDA Drug Approvals Fall in 2024, But Small Pharma Fuels Innovation Surge
The US Food and Drug Administration (FDA) approved 127 innovator and biosimilar drugs in 2024, marking a decline from the 149 approvals recorded in 2023, according to a report by leading data and analytics firm GlobalData.
US Food And Drug Administration | 19/07/2025 | By Dineshwori | 432
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