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Tag: FDA approval

You Searched For "FDA Approval"
USFDA nod to Ipratropium Bromide Nasal Solution

Lupin's Generic Entresto Approved by USFDA, Set to Rival Novartis' Bestseller

Farhat Nasim29 Jan 2025 8:04 PM IST
Mumbai: In a fresh challenge to Novartis' blockbuster heart failure drug Entresto, Indian generics maker Lupin has received approval from the U.S....
Jazz Pharmas Ziihera Gets USFDA Nod To Treat HER2-Positive Biliary Tract Cancer

Jazz Pharma's Ziihera Gets USFDA Nod To Treat HER2-Positive Biliary Tract Cancer

Farhat Nasim22 Nov 2024 12:30 PM IST
The drug zanidatamab-hrii, sold under the brand name Ziihera, is approved for use in previously treated adults with metastatic HER2-positive biliary...
Phentolamine Ophthalmic Solution Reverses Mydriasis Faster,  suggests study

Phentolamine Ophthalmic Solution Reverses Mydriasis Faster, suggests study

Dr Riya Dave2 Oct 2024 8:15 PM IST
According to research, the ophthalmic solution of phentolamine 0.75% (RYZUMV), developed by Ocuphire Pharma, strongly and quickly reverses...
FDA Approves Clobetasol Propionate Ophthalmic Suspension for Post-Operative Ocular Care

FDA Approves Clobetasol Propionate Ophthalmic Suspension for Post-Operative Ocular Care

Dr Riya Dave5 March 2024 8:00 PM IST
The FDA has approved clobetasol propionate ophthalmic suspension 0.05% (APP13007) for managing post-operative inflammation and pain following ocular...
Linaclotide Proves Effective for Pediatric Constipation

Linaclotide Proves Effective for Pediatric Constipation

Dr Riya Dave16 Jan 2024 7:00 AM IST
In a significant development for pediatric gastroenterology, linaclotide, a guanylate cyclase C agonist, has been granted approval by the US Food and...
FDA approves Depression drug after rejecting it multiple times in 20 years

FDA approves Depression drug after rejecting it multiple times in 20 years

Isra Zaman2 Oct 2023 9:15 AM IST
Gepirone hydrochloride extended-release (ER), marketed as Exxua, has finally received FDA approval for the treatment of major depressive disorder...
FDA Approves Updated mRNA Vaccines to Combat Emerging COVID-19 Variants

FDA Approves Updated mRNA Vaccines to Combat Emerging COVID-19 Variants

Jacinthlyn Sylvia13 Sept 2023 11:15 AM IST
The US Food and Drug Administration (FDA) has officially granted emergency use authorization for updated COVID-19 vaccines that are designed to better...
FDA approves first oral JAK inhibitor for treatment of alopecia areata in adolescents

FDA approves first oral JAK inhibitor for treatment of alopecia areata in adolescents

Medha Baranwal28 Jun 2023 8:00 PM IST
USA: The US FDA (Food and Drug Administration) has approved ritlecitinib (Litfulo), a Janus kinase (JAK) inhibitor, for adults and adolescents with...
Gene therapy receives FDA approval for Duchenne Muscular Dystrophy

Gene therapy receives FDA approval for Duchenne Muscular Dystrophy

Medha Baranwal24 Jun 2023 10:00 AM IST
USA: The U.S. Food and Drug Administration (FDA) has approved delandistrogene moxeparvovec (Elevidys), the first gene therapy for children 4 through 5...
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...
Tzield, first drug to delay type 1 diabetes onset, receives FDA approval

Tzield, first drug to delay type 1 diabetes onset, receives FDA approval

Medha Baranwal19 Nov 2022 11:15 AM IST
TZIELD is the first disease-modifying therapy for type 1 diabetes, a life-threatening autoimmune disease.USA: Tzield (teplizumab-mzwv), an injection...
FDA approves first drug-eluting contact lens with antihistamine for itchy eyes

FDA approves first drug-eluting contact lens with antihistamine for itchy eyes

Dr. Kamal Kant Kohli4 March 2022 8:15 AM IST
The US food and drug administration has approved first drug-eluting contact lens containing an antihistamine for people with allergic eye itch....
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