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Results For "FDA"

1718 News Found

Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug
News | December 07, 2023

Dr. Reddy's inks pact with Coya Therapeutics for development of sclerosis drug

Dr. Reddy's will make a US$ 7.5 million upfront payment to Coya


Granules India received ANDA approval for Sildenafil for oral suspension
Drug Approval | December 06, 2023

Granules India received ANDA approval for Sildenafil for oral suspension

The current annual U.S. market for Sildenafil for Oral Suspension is approximately $43 million


Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US
Drug Approval | December 02, 2023

Lupin launches Turqoz (Norgestrel and Ethinyl Estradiol) Tablets in US

Norgestrel and Ethinyl Estradiol Tablets USP (RLD: Lo/Ovral-28) had estimated annual sales of US $33 million in the US


Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial
Diagnostic Center | November 29, 2023

Dupixent significantly reduced COPD exacerbations in second positive Phase 3 trial

Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease


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


Teva announces approval of a generic version of Forteo in US
Drug Approval | November 20, 2023

Teva announces approval of a generic version of Forteo in US

This approval showcases Teva’s proven strengths in complex generic formulations development and device engineering


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


SMS Pharmaceuticals reports robust Q2FY24 operational performance
News | November 10, 2023

SMS Pharmaceuticals reports robust Q2FY24 operational performance

Q2FY24 EBITDA up by 105% y-o-y at Rs. 28 crore


Lupin launches Rocuronium Bromide injection in US
Drug Approval | November 09, 2023

Lupin launches Rocuronium Bromide injection in US

Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).