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Results For "Food-and-Drug-Administration"

1262 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


Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%
Drug Approval | December 27, 2023

Lupin receives USFDA approval for Loteprednol Etabonate Ophthalmic Suspension, 0.2%

Loteprednol Etabonate Ophthalmic Suspension, 0.2%, is indicated for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis


Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results
Drug Approval | December 26, 2023

Roche receives USFDA’s priority review to Xolair for food allergies based on positive NIH Phase III study results

If approved, Xolair would be the first medicine to reduce allergic reactions to multiple foods following an accidental exposure


Eugia's East Windsor facility gets 10 observations from USFDA
Drug Approval | December 25, 2023

Eugia's East Windsor facility gets 10 observations from USFDA

The plant is yet to start commercial operations


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


USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer
Drug Approval | December 23, 2023

USFDA grants priority review for Patritumab Deruxtecan in US for certain patients with EGFR-mutated non-small cell lung cancer

If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients


FDA grants priority review to Merck’s new biologics license application for V116
Drug Approval | December 20, 2023

FDA grants priority review to Merck’s new biologics license application for V116

V116 is an investigational, 21-valent pneumococcal conjugate vaccine specifically designed to protect adults


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


Lupin receives tentative USFDA approval for Sitagliptin Tablets
Drug Approval | December 18, 2023

Lupin receives tentative USFDA approval for Sitagliptin Tablets

Sitagliptin Tablets USP, 25 mg, 50 mg, and 100 mg are indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus