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Results For "FDA"

1782 News Found

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets
Drug Approval | December 14, 2023

Granules India received ANDA approval for Pantoprazole Sodium Delayed-Release Tablets

Pantoprazole Sodium Delayed-Release Tablets are indicated for short-term treatment of Erosive Esophagitis associated with GERD


Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories
News | December 10, 2023

Briefs: GlaxoSmithKline Pharmaceuticals and Dr. Reddy's Laboratories

Dr. Reddy's Laboratories has been issued a Form 483 with three observations


ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346
News | December 10, 2023

ExeGi Pharma announces first patient enrollment in the PROF Trial of EXE-346

First published clinical trial using live biotherapeutic candidate in Covid-19 patients suggests role in improving outcomes


Zepbound is now available in US for adults living with obesity
News | December 09, 2023

Zepbound is now available in US for adults living with obesity

Express Scripts to add Zepbound to National Preferred Formulary


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