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Results For "FDA"

1718 News Found

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn
News | January 02, 2024

Palatin completes sale of Vyleesi to Cosette Pharmaceuticals for up to $171 mn

Vyleesi is the first and only as-needed treatment approved by the Food and Drug Administration (FDA) for premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD)


Akums to empower mothers with Doxylamine + Pyridoxine extended-release tablets for severe morning sickness
News | December 28, 2023

Akums to empower mothers with Doxylamine + Pyridoxine extended-release tablets for severe morning sickness

This combination aims to offer an effective tool to manage symptoms of nausea and vomiting during pregnancy


Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment
Drug Approval | December 26, 2023

Wainua granted first-ever regulatory approval in the US for improving neuropathy impairment

US FDA approval based on NEURO-TTRansform Phase III results


Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion
News | December 24, 2023

Bristol Myers Squibb to buy Karuna Therapeutics for US$ 14 billion

Transaction delivers KarXT, a first-in-class M1/ M4 muscarinic receptor agonist with differentiated efficacy and safety


Briefs: Aurobindo Pharma and Granules Pharmaceuticals
Drug Approval | December 20, 2023

Briefs: Aurobindo Pharma and Granules Pharmaceuticals

Granules Pharmaceuticals gets 5 observations from USFDA on completion of GMP inspection


Briefs: Torrent Pharmaceuticals and Laurus Synthesis
News | December 17, 2023

Briefs: Torrent Pharmaceuticals and Laurus Synthesis

Laurus Synthesis receives Form 483 with 5 observations from USFDA


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