The Latest Breaking News from FDA

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.

“As the Covid pandemic continues to evolve and be highly unpredictable, we must remain vigilant in protecting those who are at greatest risk of getting very sick from Covid," said CEO Albert Bourla.

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.

The World Health Organization said June 25 that monkeypox wasn’t yet a public health emergency of international concern. More than 4,500 cases have been reported worldwide, with more than 300 in the U.S.

Nicotine kills. Oh, not directly, for the most part. It’s just so addictive that cigarette smokers find it nearly impossible to quit a product that subtracts years off their lives, causes cancer, chronic obstructive pulmonary disease, strokes and heart disease, along with worsening Type 2 diabetes. In 2018, more than…

Agency says they are sometimes marketed as water-therapy products

WASHINGTON — With a little green bandaid on his furry red arm, Elmo, the beloved 3 1/2-half-year-old Muppet on the long-running children’s PBS program Sesame Street, said “there was a little pinch, but it was okay” when he received his coronavirus vaccine this week.