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Results For "approval"

2608 News Found

Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India
Drug Approval | August 11, 2025

Shilpa Medicare receives approval of NorUDCA tablets for treatment of NAFLD in India

NorUDCA is the first?in?class treatment for Non?alcoholic Fatty Liver Disease (NAFLD) in India


Zydus receives final approval from USFDA for Prucalopride Tablets
Drug Approval | August 09, 2025

Zydus receives final approval from USFDA for Prucalopride Tablets

Prucalopride is prescribed for chronic idiopathic constipation


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


Zydus receives tentative approval from USFDA for Ibrutinib tablets
Drug Approval | July 24, 2025

Zydus receives tentative approval from USFDA for Ibrutinib tablets

Ibrutinib tablets will be produced at Zydus Lifesciences Ltd (SEZ), Ahmedabad


Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer
Drug Approval | July 21, 2025

Bayer’s Nubeqa receives EU approval for patients with advanced prostate cancer

European Commission granted approval of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC)


Zydus receives final approval from USFDA for Celecoxib Capsules
Drug Approval | July 15, 2025

Zydus receives final approval from USFDA for Celecoxib Capsules

Celecoxib is a nonsteroidal anti-inflammatory drug


Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’
Drug Approval | July 13, 2025

Moderna receives USFDA approval for Covid-19 vaccine ‘Spikevax’

Spikevax is now approved for all individuals aged 6 months through 64 years at increased risk for COVID-19 disease