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News about "US Food and Drug Administration "
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 | 132
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
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 | 177
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 | 206
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 | 201
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 | 407
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 | 381
Johnson & Johnson Secures US FDA Priority Review for TAR-200 NDA
Johnson & Johnson has announced that the US FDA has granted Priority Review to its New Drug Application for TAR-200, a first-of-its-kind intravesical gemcitabine-releasing system, for treating BCG-unresponsive high-risk non-muscle invasive bladder cancer with carcinoma in situ.
US Food And Drug Administration | 18/07/2025 | By Mrinmoy Dey | 113
GSK Secures FDA Approval for Prefilled Syringe Version of Shingles Vaccine Shingrix
GSK has received approval from the US Food and Drug Administration (FDA) for a new prefilled syringe presentation of Shingrix (Recombinant Zoster Vaccine, RZV), designed to prevent shingles (herpes zoster).
US Food And Drug Administration | 17/07/2025 | By Dineshwori | 400
Bayer Seeks US FDA Approval of gadoquatrane for MRI of CNS and Other Body Parts
Bayer has submitted a New Drug Application to the US FDA for gadoquatrane, an investigational MRI contrast agent. If approved, it would offer the lowest gadolinium dose among macrocyclic GBCAs in the US, cutting exposure by 60 percent while maintaining diagnostic efficacy.
US Food And Drug Administration | 18/06/2025 | By Abha | 160
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