On November 5, 2020, the United States Court of Appeals for the Federal Circuit, in Valeant Pharmaceuticals N. Am. LLC v. Mylan Pharmaceuticals Inc., No. 19-2402, resolved a split among district ...

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🔺NDA (New Drug Application) and ANDA (Abbreviated New Drug Application) are two types of regulatory submissions to the FDA for approval of new drugs. 🔸NDA (New Drug Application) 1.

Axsome Therapeutics, Inc. (NASDAQ:AXSM) signed a settlement agreement with Teva Pharmaceuticals Inc (NYSE:TEVA). The ...

Shares of Axsome Therapeutics (NASDAQ: AXSM) are flying higher on Monday. The move up comes as the S&P 500 (SNPINDEX: ^GSPC) ...

Axsome Therapeutics, Inc. (NASDAQ: AXSM) (Axsome), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, ...

Lisdexamfetamine Dimesylate is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and ...

Mumbai: Global pharma major Lupin Limited has announced that it has received approval from the United States Food and Drug ...

This week, the Supreme Court announced that “reverse payment” settlements of patent litigation between branded and generic pharmaceutical companies are, when challenged in a subsequent ...

Hyderabad: NATCO Pharma Limited has announced final approval of its Abbreviated New Drug Application (ANDA) for Bosentan ...

Axsome Therapeutics (AXSM) announced that it has entered into a settlement agreement with Teva Pharmaceuticals (TEVA) resolving all patent ...

Bosentan Tablets for Oral Suspension are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital ...