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Results For "new-drug-application"

435 News Found

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA
News | August 13, 2025

Senores Pharmaceuticals acquires ANDAs from Teva Pharmaceuticals USA

The acquired ANDAs represent a market opportunity of about US$ 38 million in the USA


Briefs: Nectar Lifesciences, Cipla and Marksans Pharma
News | August 12, 2025

Briefs: Nectar Lifesciences, Cipla and Marksans Pharma

Marksans Pharma gets USFDA nod for acid reflux drug


Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags
Drug Approval | August 12, 2025

Gland Pharma gets approval for Norepinephrine Bitartrate in 5% Dextrose injection bags

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Norepinephrine Bitartratein 5% Dextrose of Baxter Healthcare Corp


Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial
Drug Approval | August 12, 2025

Gland Pharma receives FDA approval for Cangrelor for Injection 50 mg/vial

The product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), KENGREAL of Chiesi USA


AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients
Drug Approval | August 06, 2025

AbbVie submits for FDA approval of Venclexta and Acalabrutinib combination for untreated CLL patients

The submission is supported by positive results from the Phase 3 AMPLIFY trial


Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP
Drug Approval | July 27, 2025

Alembic Pharmaceuticals announces USFDA final approval for Carbamazepine ER Tablets USP

Carbamazepine Extended-Release Tablets are indicated for use as an anticonvulsant drug


Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products
Drug Approval | July 24, 2025

Lupin receives USFDA approvals for Liraglutide and Glucagon injectable products

Both these products will be manufactured at Lupin’s Injectable facility at Nagpur, India


Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys
Drug Approval | July 21, 2025

Sarepta refuses to comply with FDA request to stop shipping gene therapy Elevidys

FDA requests Sarepta Therapeutics to suspend distribution of Elevidys and places clinical trials on hold for multiple gene therapy products following 3 deaths


FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%
Drug Approval | July 15, 2025

FDA approves Bayer’s Finerenone for new indication in patients with HF and LVEF of ?40%

Finerenone significantly reduced the combined risk of cardiovascular death and total (first and recurrent) heart failure events,


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel
Drug Approval | July 02, 2025

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Gel

Loteprednol Etabonate Ophthalmic Gel, 0.38% is a corticosteroid indicated for the treatment of postoperative inflammation and pain following ocular surgery