Merck MRK announced that the FDA has accepted its supplemental new drug application (sNDA) seeking approval of its oral ...

The FDA has accepted a priority review sNDA for Welireg in adults and pediatric patients with advanced or metastatic ...

The Securities Commission of The Bahamas (SCB) has assessed $221.55 million in regulatory penalties against FTX Digital ...

IceCure's IceSense3, its predecessor cryoablation system, already has regulatory approval in China. The indicated use for ProSense® in China, per the Company's regulatory filing application ...

The Company also provided an update on key corporate, clinical, and regulatory development ... KDIGO guidelines and potential approval of the recently accepted sNDA to modify liver monitoring ...

Crypto exchange Coinbase (COIN) said it received regulatory approval to offer services to users in Argentina. The company received a Virtual Asset Service Provider (VASP) registration from ...

(RTTNews) - Johnson & Johnson (JNJ), Tuesday announced that the U.S. Food and Drug Administration has approved supplemental New Drug Application or sNDA for Spravato, a monotherapy for adults with ...

We are pleased to announce that our applications for the higher dose regimen of nusinersen are now under review in the US and Europe,” said Stephanie Fradette, Pharm.D., Head of the Neuromuscular ...