FDA has determined that NRx’s Abbreviated New Drug Application (ANDA) is “substantially complete” and received for review.

If approved, ReadyFlow Autoinjector would deliver an IV-equivalent diuretic dose (subcutaneous furosemide injection 80 mg/ml) in under 10 ...

Submission of NDA in South Korea by Lotus Pharmaceutical results in the second ex-U.S. regulatory submission for VIZZSAN DIEGO and TAIPEI, Taiwan, Dec. 01, 2025 (GLOBE NEWSWIRE) -- LENZ Therapeutics, ...

Wockhardt's share price surged 6.5% following FDA acceptance of its New Drug Application for Zaynich, marking a significant ...

NDA for treatment of sBCC with Ameluz®-PDT submitted to U.S. Food and Drug Administration (FDA) on November 28, 2025First ...

Drugmaker Wockhardt said that the United States Food and Drug Administration (US FDA) had accepted the New Drug Application ...

The market capitalization of the company has soared by Rs 5,400 crore in these two days of sharp gains to Rs 25,493 crore.

Centanafadine is a first-in-class norepinephrine, dopamine, and serotonin reuptake inhibitor (NDSRI). Clinical studies have shown that centanafadine significantly reduces core symptoms of ADHD in ...

Nuvalent filed a new drug application for an experimental non-small cell lung cancer treatment with the Food and Drug Administration.

Please provide your email address to receive an email when new articles are posted on . Zabalafin Hydrogel is a novel, first-in-class, multi-target therapeutic plant-based drug. Phase 2b and phase 3 ...

Eisai (ESAIY) and Biogen (BIIB) announced that Eisai has filed a new drug application for Leqembi seeking approval for a subcutaneous formulation ...