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Tag: US FDA

You Searched For "US FDA"
Serious liver injury in patients taking Ocaliva to treat primary biliary cholangitis

FDA Issues Urgent Safety Warning on Ocaliva, Highlights Risk of Serious Liver Injury in Primary Biliary Cholangitis Patients

Medha Baranwal15 Dec 2024 8:45 PM IST
USA: The U.S. Food and Drug Administration (FDA) has issued an important update to its Drug Safety Communication regarding Ocaliva (obeticholic acid),...
US FDA nod to Eli Lillys Eczema drug Ebglyss

US FDA nod to Eli Lilly's Eczema drug Ebglyss

MD Bureau Team15 Sept 2024 1:30 PM IST
Bengaluru: Eli Lilly said on Friday the U.S. Food and Drug Administration approved its eczema drug for use in adults and children above 12...
FDA Alerts on Overdosing Risks with Compounded Semaglutide Due to Dosing Errors and Variability

FDA Alerts on Overdosing Risks with Compounded Semaglutide Due to Dosing Errors and Variability

Medha Baranwal1 Aug 2024 9:30 AM IST
USA: Patients are experiencing overdoses of compounded semaglutide due to errors in both self-administration and clinician calculations, which may...
FDA approves once-daily oral antihypertensive Aprocitentan for uncontrolled BP

FDA approves once-daily oral antihypertensive Aprocitentan for uncontrolled BP

Medha Baranwal21 March 2024 8:00 PM IST
USA: The US Food and Drug Administration (FDA) has approved aprocitentan (Tryvio) for treating hypertension in combination with other antihypertensive...
Top Ten US-FDA Approved Pharmacological Agents in 2023: A Year in Review

Top Ten US-FDA Approved Pharmacological Agents in 2023: A Year in Review

MDTV Bureau30 Dec 2023 3:51 PM IST
We come to the end of 2023. Here are top ten pharmacological agents that received US-FDA approval throughout this year, across key therapy areas:1)...
FDA OKs first renal denervation device for hypertension treatment

FDA OKs first renal denervation device for hypertension treatment

Medha Baranwal14 Nov 2023 10:45 AM IST
USA: The US Food and Drug Administration (FDA) has approved Recor's Paradise Ultrasound Renal Denervation (RDN) system for hypertension treatment. The...
FDA approves expanded use of inclisiran for primary hyperlipidemia

FDA approves expanded use of inclisiran for primary hyperlipidemia

Dr. Kamal Kant Kohli13 July 2023 10:00 AM IST
The US Food and Drug Administration has approved expanded use of inclisiran (Leqvio) for primary hyperlipidemia besides its existing indications of...
Worlds first dual-chamber leadless pacemaker receives FDA approval for cardiac arrhythmia

World's first dual-chamber leadless pacemaker receives FDA approval for cardiac arrhythmia

Medha Baranwal7 July 2023 11:30 AM IST
USA: The US FDA (Food and Drug Administration) has approved the first chamber leadless pacing system, Aveir DR dual-chamber leadless pacemaker, for...
FDA Approves Colchicine as breakthrough for lowering CVD events

FDA Approves Colchicine as breakthrough for lowering CVD events

Chumbeni22 Jun 2023 10:30 AM IST
USA: Colchicine 0.5 mg (to be sold as Lodoco) has been approved by the US Food and Drug Administration (FDA), making it the first anti-inflammatory...
FDA withdraws preterm birth drug Makena (hydroxyprogesterone) and its generic versions

FDA withdraws preterm birth drug Makena (hydroxyprogesterone) and its generic versions

Medha Baranwal10 April 2023 10:30 AM IST
USA: Noting that the drug was ineffective in treating the complication of preterm birth, the US Food and Drug Administration (FDA), in its recent...
Non-invasive, digital self-neuromodulation, Prism for PTSD, receives FDA clearance

Non-invasive, digital self-neuromodulation, Prism for PTSD, receives FDA clearance

Medha Baranwal1 April 2023 10:00 AM IST
USA: The maker announced that the FDA cleared GrayMatters Health's Prism-a non-invasive, digital self-neuromodulation-for patients with post-traumatic...
FDA approves Leqembi for treatment of Alzheimers disease

FDA approves Leqembi for treatment of Alzheimer's disease

Dr. Kamal Kant Kohli9 Jan 2023 8:00 PM IST
USA: The US Food and drug administration has granted approval to a new drug (Leqembi) designed to slow cognitive decline in patients with early...
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