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J&J says FDA approves SC induction regimen of Tremfya
20 Sep 2025 07:14 GMT
… announced that the U.S. Food and Drug Administration has approved a subcutaneous induction …
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FDA Introduces Pilot Program to Expedite Nicotine Pouch PMTAs
20 Sep 2025 04:01 GMT
The Food and Drug Administration (FDA) has launched a pilot … tobacco products (such as FDA authorized nicotine pouches) can … chemicals,” the FDA’s statement continued.
The FDA will ultimately … real-time communication between FDA and applicants with the …
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Merck announces FDA approval of Keytruda Qlex
20 Sep 2025 07:14 GMT
… ) announced that the U.S. FDA has approved Keytruda Qlex injection …
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<![CDATA[FDA Approves Guselkumab (Tremfya) Subcutaneous Induction Regimen for Ulcerative Colitis]]>
20 Sep 2025 02:36 GMT
The US Food and Drug Administration (FDA) has approved a subcutaneous (SC) … received initial approval from the FDA in 2017 for treatment of … , results were consistent with the FDA-approved 200mg IV induction regimen …
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Hundreds of radiation therapy systems subject to FDA recall
20 Sep 2025 02:23 GMT
… ,” a notice from U.S. Food and Drug Administration reads.
In August, Philips sent …
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FDA approves pembrolizumab for subcutaneous injection for solid tumors
20 Sep 2025 02:36 GMT
… 19, 2025, the FDA approved pembrolizumab and berahyaluronidase … received IV pembrolizumab.
The FDA also noted, “The … toxicity.”
REFERENCES
1. FDA approves pembrolizumab and berahyaluronidase … -approved-drugs/fda-approves-pembrolizumab-and-berahyaluronidase …
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<![CDATA[FDA Approves Keytruda Qlex Subcutaneous Injection for Adult and Pediatric Patients With Solid Tumors]]>
20 Sep 2025 02:31 GMT
The FDA approved pembrolizumab and berahyaluronidase alfa- … and healthy cells. Pembrolizumab has FDA-approved indications as monotherapy and …
It is recommended by the FDA that, in this combination, 395 …
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Stealth BioTherapeutics Announces FDA Accelerated Approval of FORZINITY™ (elamipretide HCl), the First Therapy for Progressive and Life-limiting Ultra-rare Genetic Disease Barth Syndrome
20 Sep 2025 02:05 GMT
… that the U.S. Food and Drug Administration (FDA) has granted accelerated … or FDA at 1-800-FDA-1088 or www.fda.gov … well as the first FDA-approved mitochondria-targeted therapeutic … 47;stealth-biotherapeutics-announces-fda-accelerated-approval-of-forzinity …
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<![CDATA[Stuttering, Research, and the Push for FDA-Approved Therapies: A Conversation With Gerald McGuire, MD]]>
20 Sep 2025 02:23 GMT
… an overlooked condition with no FDA-approved therapies. The Stuttering … have any truly effective, FDA-approved treatments. This is … t have evidence-based, FDA-approved treatments that can … trials, even though nothing is FDA-approved yet.
For psychiatrists, …
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FDA Unleashes Wave of Enforcement: The Industry Faces a Crackdown on Drug Advertising
20 Sep 2025 01:48 GMT
… , 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion … and regulatory exemptions. Additionally, FDA scrutiny is extending to artificial … Loss | FDA.; Compounding and the FDA: Questions and Answers | FDA; FDA alerts health …