The Latest Breaking News from FDA

According to a recent report from the US House select subcommittee on the coronavirus crisis, Emergent Biosolutions Inc (NYSE:EBS) might have destroyed nearly 400 million doses of COVID-19 vaccines after failing to meet quality standards. Initially, 75 million - 85 million doses of drug substance were said to be destroyed after contamination.  "Despite major…

Avadel Pharmaceuticals PLC (NASDAQ: AVDL) reported 1Q results and provided updated color on the U.S. marketing application for FT218.

Joseph Kim, the longtime CEO of Inovio Pharmaceuticals Inc (NASDAQ:INO), is stepping down to make room for Jacqueline Shea, who first joined Inovio as COO in 2019. Shea will be overseeing a change in direction as Inovio, a laggard in the COVID-19 vaccine race, has closed a Phase 3 trial in favor of a…

Here's a roundup of top developments in the biotech space over the last 24 hours:

Regulus Therapeutics Inc. (NASDAQ: RGLS) announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for RGLS8429 for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

The U.S. Food and Drug Administration (FDA) has approved OLUMIANT® (baricitinib) for the treatment of COVID-19 in hospitalized patients.

In a Pre-EUA meeting, FDA said Veru Inc (NASDAQ:VERU) should submit a request for FDA emergency use authorization for sabizabulin in hospitalized COVID-19 patients. The FDA agreed that the Phase 3 COVID-19 study stopped by the Independent Data Monitoring Committee for overwhelming efficacy is sufficient to support the efficacy portion of a request for…

Along with much of the globe, US consumers are reeling from a cost of living and supply-chain crisis. One example is a shortage of baby formula caused by a constellation of factors, from rampant inflation to a massive recall over safety concerns.

The FDA approved Eli Lilly And Co's (NYSE:LLY) Olumiant (baricitinib) for COVID-19 in hospitalized adults requiring supplemental oxygen, mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).  Olumiant is the first immunomodulatory treatment for COVID-19 to receive FDA approval.  The FDA first issued an emergency use authorization (EUA) for Olumiant combined with remdesivir to treat…