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Results For "FDA"

2187 News Found

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


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