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Results For "FDA-approval"

438 News Found

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease
Drug Approval | December 09, 2023

Vertex and CRISPR Therapeutics announce USFDA approval of Casgevy for treatment of sickle cell disease

Approximately 16,000 patients 12 years of age and older with severe sickle cell disease may now be eligible for this one-time treatment


Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH
Drug Approval | December 08, 2023

Novartis receives FDA approval for Fabhalta as the first oral monotherapy for adults with PNH

Late-stage Fabhalta development program ongoing in multiple complement-mediated conditions


Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension
Drug Approval | December 01, 2023

Eugia Pharma receives USFDA approval for Budesonide Inhalation Suspension

The product is expected to be launched in FY25


Strides receives USFDA approval for generic Suprep bowel prep kit
Drug Approval | November 23, 2023

Strides receives USFDA approval for generic Suprep bowel prep kit

The Product will be manufactured at the company's facility in Bengaluru


Strides receives USFDA approval for Levetiracetam Oral Solution
Drug Approval | November 21, 2023

Strides receives USFDA approval for Levetiracetam Oral Solution

The product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD) and is used in the treatment of seizures.


Kesin Pharma announces FDA approval and availability of Likmez oral suspension
Drug Approval | November 15, 2023

Kesin Pharma announces FDA approval and availability of Likmez oral suspension

Likmez oral suspension is the first and only FDA-approved liquid option for patients with adherence hurdles such as dysphagia, difficulty swallowing


Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules
Drug Approval | October 05, 2023

Marksans Pharma gets USFDA approval for Esomeprazole Magnesium delayed-release capsules

This product is bioequivalent to the reference listed drug (RLD), Nexium 24 HR Delayed- Release Capsules, 2.0mg (OTC), of AstraZeneca Pharmaceuticals


Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets
Drug Approval | October 05, 2023

Strides receives USFDA approval for Efavirenz, Emtricitabine & Tenofovir Disoproxil Fumurate tablets

The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products