The Latest Breaking News from FDA

The updated shots will provide more protection against subvariants that now make up more than 50% of U.S. cases.

U.S. regulators are telling COVID-19 vaccine makers to tweak any booster doses intended for fall so they protect against the newest omicron relatives

Concerns over the Federal Reserve’s aggressive interest rate hikes to fight elevated inflation and the possibility of the economy tipping into a recession have fostered significant volatility in the market of late. Despite the market uncertainties, Wall Street analysts expect fundamentally sound sub-$5 stocks Provention Bio (PRVB) and Trevi (TRVI)…

The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Aura Biosciences’ (NASDAQ: AURA) belzupacap sarotalocan (AU-011) for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC).

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

Avadel Pharmaceuticals plc (NASDAQ: AVDL) announced its steps to explore every available pathway to accelerate the FDA approval of its lead drug candidate, FT218, before June 2023. 

AstraZeneca Plc (NASDAQ:AZN) announced high-level results from a planned interim analysis of the AEGEAN Phase 3 trial of Imfinzi (durvalumab) combined with neoadjuvant chemotherapy in patients with resectable non-small cell lung cancer (NSCLC). The data showed that Imfinzi plus neoadjuvant chemo before surgery demonstrated a statistically significant and meaningful improvement in pathologic complete…

The FDA has placed Sanofi SA's (NASDAQ:SNY) Phase 3 studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold.  New enrollment in the U.S. is paused, and participants in the U.S. who have been in the trial for fewer than 60 days shall suspend the study drug.  The participants who…

Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) have announced a new vaccine supply agreement with the U.S. government. Under the agreement, the U.S. government will receive 105 million doses (30 µg, 10 µg and 3 µg). This may include adult omicron-adapted COVID-19 vaccines, subject to the FDA authorization.  The doses are planned to be delivered…

The FDA will have to decide the exact recipe. But expect a combination shot that adds protection against omicron or some of its newer relatives to the original vaccine.

Gainers Allena Pharmaceuticals, Inc. (NASDAQ: ALNA) shares surged 114.3% to close at $0.2550 on Wednesday after the company announced it has terminated its previously announced at-the-market offering.