3 There are four categories of drugs available on market without FDA approval: 1. DESI Pending – DESI drugs may stay on the market under current policies. 2. Over the Counter (OTC) Monograph ...

In the U.S., FDA cycle times are calculated from the time a drug is submitted for approval to when it is granted approval. Almost immediately after the FDA grants approval, the drug is authorized ...

Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) have secured US Food and Drug Administration approval for a once-monthly intravenous maintenance dosing regimen for Leqembi (lecanemab). Already approved ...

Biogen has announced that the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) have started reviewing a higher dose regimen of its spinal muscular atrophy (SMA) treatment ...

LAKE CHARLES, La. (KPLC) - Nearly 40 million Americans struggle with sleep apnea, but a drug approved in December may help. The U.S. Food and Drug Administration calls Zepbound the first and only ...

In an important regulatory win for Denmark’s Novo Nordisk (NOV: N), the US Food and Drug Administration (FDA) yesterday approved Ozempic (semaglutide) to reduce the risk of kidney disease worsening, ...

The new indications, approved Tuesday by the FDA, make Ozempic the most broadly indicated drug in its class, with the largest set of specific medical conditions that it may be prescribed to treat.

Eisai (ESAIY) and Biogen (BIIB) announced that the U.S. Food and Drug Administration, FDA, has approved the Supplemental Biologics License Application, sBLA, for once every four weeks lecanemab ...

MODEC and Toyo Engineering have jointly obtained an Approval in Principle (AiP) from ABS for a Blue Ammonia FPSO that will produce ammonia from the gas supplied by a traditional FPSO located nearby.

announced that the Therapeutic Goods Administration (TGA) in Australia has approved its treatment SYFOVRE® (pegcetacoplan) for adult patients suffering from geographic atrophy (GA) secondary to ...

At boot Düsseldorf 2025, YANMAR Marine International (YMI) will exhibit the new electric E-Saildrive series ahead of its consumer release in June 2025, as well as its HVO-approved inboard marine ...