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FDA approves over-the-counter sales of Narcan. But would you know what to do to save a life?
In a move that health experts say may reduce the number of fentanyl deaths, the FDA has approved over-the-counter sales of Narcan nasal spray -- a medication that rapidly reverses fentanyl overdose.
Medscape6d
FDA Approves Ustekinumab Biosimilar Yesintek
The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque ...
WebMD7d
FDA Approves New SVT Drug for Critical Care Use
The FDA has approved Rapiblyk, a new drug to treat irregular heartbeats in critically ill hospitalized patients with severe supraventricular tachycardia (SVT), including atrial fibrillation and ...
Reuters5d
FDA approves AstraZeneca's Imfinzi for limited-stage small cell lung cancer
Dec 4 (Reuters) - The U.S. Food and Drug Administration has approved AstraZeneca (AZN.L), opens new tab blockbuster drug Imfinzi to treat some adults with limited-stage small cell lung cancer, the ...
WebMD28d
FDA Approves New Immunotherapy for Aggressive Leukemia
The FDA has approved a new treatment, Aucatzyl, for a type of aggressive blood cancer called B-cell acute lymphoblastic leukemia (B-cell ALL). This treatment, a CAR T-cell immunotherapy ...
The American Journal of Managed Care13d
FDA Approves Imatinib Oral Solution for Treatment of Various Cancers
Safety and efficacy in pediatric Ph+ ALL populations have not been established. The FDA approval marks the first oral solution indicated for patients with different forms of leukemia.
The American Journal of Managed Care14d
FDA Approves Acoramidis for ATTR-CM
Acoramidis is the first FDA-approved treatment for ATTR-CM with near-complete TTR stabilization, reducing cardiovascular death and hospitalization. The phase 3 ATTRibute-CM trial showed acoramidis ...
Business Wire1mon
FDA Approves Novocure’s Optune Lua® for the Treatment of Metastatic Non-Small Cell Lung Cancer
Optune Lua is a wearable, portable, FDA-approved device used together with PD-1/PD-L1 inhibitors (immunotherapy) or docetaxel. It is indicated for adult patients with metastatic non-small cell ...
TCTMD1mon
FDA Approves Varipulse Pulsed-Field Ablation System for AF
The FDA approval was based on results from the admIRE trial, a single-arm, investigational device exemption study conducted at 30 US centers. Among 277 patients with drug-refractory, symptomatic ...
Nasdaq16d
BridgeBio Pharma : FDA Approves Heart Disease Drug 'acoramidis'
The FDA approval is based on positive results seen in the ATTRibute-CM Phase 3 study, where Attruby significantly reduced death and cardiovascular-related hospitalization, and improved quality of ...
Benzinga.com13d
FDA Approves BridgeBio Pharma's Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market
FDA approves BridgeBio's Attruby for ATTR-CM, the first treatment labeled for near-complete stabilization of TTR in adults. ATTRibute-CM Phase 3 trial showed significant improvements in ...