The Latest Breaking News from FDA

By John Vandermosten, CFA NASDAQ:LPCN READ THE FULL LPCN RESEARCH REPORT

FDA Chief Recognizes Slow Progress On CBD Regulations   Dr. Robert M. Califf confirmed on Thursday at a congressional panel that the FDA has made little progress on the regulatory framework around CBD products over the years since Trump signed the Farm Bill in late 2018.

TherapeuticsMD Inc (NASDAQ:TXMD) shares are trading higher after FDA approved the supplemental application, including minor revisions to Annovera's in vitro release testing specification that allowed for normal manufacturing variability. The FDA approved Annovera in August 2018 as the only long-lasting, reversible, procedure-free birth control. With the approval of the supplemental application, the company believes…

U.S. stocks traded higher this morning. Following the market opening Friday, the Dow traded up 0.20% to 31,316.89 while the NASDAQ rose 0.35% to 11,428.90. The S&P also rose, gaining, 0.34% to 3,914.24.

Formula isn’t just for babies. April Crohare desperately needs it for her 14-year-old son, Charlie. Due to medical complications from a rare brain disorder called lissencephaly, his only source of nutrition comes from infant formula through a feeding tube.

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

The Centers for Disease Control and Prevention recommended that children ages 5 to 11 receive the newly authorized COVID-19 booster shot from Pfizer Inc (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX). Following the recommendation, many of the nation's doctors, pharmacies, and other vaccination sites are expected to begin offering the extra doses to the 28 million U.S. children…

Recent rule changes made it easier for patients to get abortion pills through the mail, using telehealth services. Now there is growing demand for these services – and new legal battles brewing.

The FDA has instituted a clinical hold on Foghorn Therapeutics Inc's (NASDAQ:FHTX) Phase 1 dose-escalation study of FHD-286 in relapsed and/or refractory acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS).  The FDA initiated the partial clinical hold following the report of a recent death that occurred in a subject with potential differentiation syndrome.  Differentiation…

Economists condemn ‘rot’ in system after manufacturer issued billions in stock buybacks despite problems at Michigan factory

Gainers NeuroMetrix, Inc. (NASDAQ: NURO) shares jumped 76.3% to close at $5.50 on Thursday after the company announced the FDA has granted De Novo authorization to market the Quell neuromodulation device as an aid for reducing the symptoms of fibromyalgia.