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Results For "Food-and-Drug-Administration"

1017 News Found

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution
Drug Approval | November 24, 2023

Lupin receives approval from USFDA for Bromfenac Ophthalmic Solution

Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain


Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Drug Approval | November 22, 2023

Lupin receives tentative approval from USFDA for Dapagliflozin Tablets

Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US


Lupin receives approval from USFDA for Pitavastatin Tablets
Drug Approval | November 22, 2023

Lupin receives approval from USFDA for Pitavastatin Tablets

Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol


Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer
Drug Approval | November 22, 2023

Truqap plus Faslodex approved in the US for patients with advanced HR-positive breast cancer

First-in-class AKT inhibitor has potential to reshape treatment for breast cancer patients


GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia
Drug Approval | November 21, 2023

GSK receives positive CHMP opinion recommending momelotinib for myelofibrosis patients with anaemia

Decision on EU marketing authorisation expected for momelotinib by early 2024


Lupin receives approval from US FDA for Ganirelix Acetate Injection
Drug Approval | November 20, 2023

Lupin receives approval from US FDA for Ganirelix Acetate Injection

The product will be manufactured at Lupin’s Nagpur facility in India


Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India
News | November 17, 2023

Dr. Reddy's rolls out drug-free non-invasive migraine management device ‘Nerivio’ in India

Nerivio is a prescription-based non-invasive device intended for acute and prophylactic (preventive) treatment of migrain


FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric
Drug Approval | November 17, 2023

FDA approves Merck’s Keytruda plus chemotherapy as first line treatment for locally advanced Metastatic HER2-Negative Gastric

Approval based on results from the Phase 3 KEYNOTE-859 trial, which demonstrated significant improvement in overall survival in these patients versus chemotherapy alone


Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting
Drug Approval | November 17, 2023

Pfizer and Astellas' XTANDI approved by USFDA in earlier prostate cancer treatment setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy in nonmetastatic castration-sensitive prostate cancer