Axsome Therapeutics’ AXSM Auvelity (AXS-05) was launched in the United States in 2022 for the treatment of major depressive disorder (MDD), making it the first approved drug in the company’s portfolio ...

Q4 2024 Earnings Call Transcript March 13, 2025 Cellectar Biosciences, Inc. beats earnings expectations. Reported EPS is ...

Company expects to submit New Drug Application (NDA) in April 2025 - DEER PARK, Ill., March 14, 2025 (GLOBE NEWSWIRE) -- Eton ...

Specialty pharmaceutical company PharmaTher Holdings’ drug application for Ketamine has received a June 4 approval goal date, advancing approval of the drug in the U.S. PharmaTher said it is ...

Discover how outsourcing regulatory submission content development improves efficiency and ensures compliance.

Promising Nonalcoholic Steatohepatitis Therapies such as AZD2693, Saroglitazar Magnesium 4 mg, Semaglutide (SEMA), Cilofexor ...

The FDA accepted a new drug application for SYD-101 to slow the progression of pediatric myopia and assigned a Prescription ...

The FDA has set a PDUFA target action date of October 23, 2025, for the low-dose atropine formulation.

Treatments for dry eye disease, neuroendocrine tumors, chronic spontaneous urticaria, Barth syndrome, and migraine are under review.

YSRCP leader P Sivashankar Reddy on Friday alleged that Chief Minister N Chandrababu Naidu, Deputy Chief Minister Pawan Kalyan, Nara Lokesh, and D Purandeswari orchestrated a conspiracy to defame the ...

This follows the final approval from the US FDA for its abbreviated new drug application (ANDA). Shares of Lupin Ltd ended at ...

Pharmaceuticals (SCPH) announced that the FDA has approved the supplemental new drug application for Furoscix to expand the indication to ...