The Latest Breaking News from FDA

Novavax Inc (NASDAQ:NVAX) filed an application with Britain's drugs regulator for the authorization of its COVID-19 vaccine among adolescents aged 12 and older. Britain had in February cleared the two-dose vaccine, Nuvaxovid, for use in adults. Novavax's submission includes data from a late-stage trial in the U.S., where the vaccine showed 80% efficacy among…

The FDA has approved AstraZeneca plc (NASDAQ:AZN) and Daiichi Sankyo's (OTC:DSKYF) Enhertu (trastuzumab deruxtecan) for adult patients with unresectable or metastatic HER2-positive breast cancer. The approval covers patients who have received a prior anti-HER2-based regimen either in the metastatic setting or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within…

WASHINGTON — The future of abortion in the U.S. is moving to the mailbox.

Food and Drug Administration warns against unproven health claims of delta-8 THC and packaging that appeals to children

22nd Century Group, Inc. (NASDAQ: XXII) reported results for the first quarter ended March 31, 2022.. The company will host a live audio webcast on May 5, at 10:00 a.m. ET.

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

Last week, Moderna became the first manufacturer to officially ask the Food and Drug Administration to approve its COVID-19 vaccine for children under 6 years old. One of three companies with authorized COVID-19 vaccines in the United States, Moderna made the request a month after saying its data showed efficacy…

More than half of abortions in America are now done with pills, rather than surgery

There is “no evidence” that a second course of Pfizer Inc.’s Paxlovid will help COVID-19 patients whose symptoms return after an initial course of the antiviral, a U.S. Food and Drug Administration official said a day after Pfizer executives advocated the idea.

U.S. regulators are concerned about the safety of cannabis compounds taken by animals leaching into human foods like milk and eggs.

The U.S. Food and Drug Administration issued warning letters to five companies for selling products containing delta-8 THC in ways that violate the Federal Food, Drug, and Cosmetic Act. This action is the first time the FDA has issued warning letters for products containing delta-8 THC.