U.S. Food and Drug Administration

A new study has warned that declining childhood vaccination rates in the United States could trigger a dramatic resurgence of diseases that were eradicated years ago. What Happened: On Sunday, former U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb shared a study on X...

The U.S. Food and Drug Administration (FDA) may approve updated COVID-19 vaccines this week to combat recent strains as the country endures its most significant summer outbreak in two years. The FDA is expected to give the nod to updated mRNA vaccines from Moderna, Inc. (NASDAQ:MRNA) and Pfizer Inc...

Three Key Takeaways: FDA Nods to MDMA Therapy Application: The FDA has accepted Lykos Therapeutics’ application for MDMA-assisted therapy for PTSD, marking a significant step in recognizing psychedelic therapies’ medical potential. A Milestone in Psychedelic Research: This development...

This is an excerpt from the March 4, 2021 edition of Medically Necessary, a health care supply chain newsletter. Subscribe here. Good afternoon. Medically Necessary is a newsletter by Matt Blois about the health care supply chain — how we get drugs, devices and medical supplies to health care...

The United States Food and Drug Administration is willing to expedite the COVID-19 vaccine authorization process, including granting emergency use authorization to a candidate before it completes late-stage clinical trials, according to Chairman Stephen Hahn. What Happened: Hanh told the...

Poseida Therapeutics Inc. (NASDAQ: PSTX) stock dropped about 34.5% in the after-hours trading on Monday, after a patient died in a prostate cancer drug trial, according to a filing the company made with the United States Securities and Exchange Commission. What Happened The trial was carried out in...

The shares of Alterity Therapeutics Ltd. (NASDAQ: ATHE) advanced in the after-hours session trading in New York on Monday and in the regular session in Sydney on Tuesday. What Happened: The surge came as Alterity Therapeutics reported positive data from an animal testing of ATH434 — its leading...

The Food and Drug Administration is eyeing the creation of a regulatory framework for e-cigarettes, a product that government data shows is increasingly popular with teenagers — and tobacco stocks are reacting to the downside.  The FDA started the largest-ever tobacco compliance...

After striking a 10-year high in June, Altria Group Inc (NYSE: MO) saw a 16-percent pullback driven largely by the Food and Drug Administration’s call to reduce cigarette nicotine. Cowen Equity Research had initially reacted to the news with a $60 price target and Hold rating, but now, amid...

Puma Biotechnology Inc (NASDAQ: PBYI) popped 88 percent Monday on news that its neratinib candidate, an early-stage breast cancer treatment for human epidermal growth factor receptor-2 (HER2) positive mutations, was advancing in the U.S. Food and Drug Administration investigatory process. For...

Sarepta Therapeutics Inc (NASDAQ: SRPT) was trading higher Friday after a Thursday-night update of Exondys 51 annual sales guidance from $80 million to $95 million. The figure still fell short of Oppenheimer’s $100 million estimate — and analyst Hartaj Singh even considers his rate...

Neither Republicans nor Democrats are eager to cut the National Institutes of Health funding by the president’s suggested $5.8 billion, but with the proposal still on the table, the sum is not yet safe. And as 18 percent of the current $31.7 billion budget hangs in the balance, more Americans...

TherapeuticsMD Inc (NYSE: TXMD) has waned as much as 40 percent since April 7, when the company received an FDA letter noting deficiencies in the new drug application for vulvovaginal atrophy treatment, Yuvvexy (TX-004HR). The regulatory agency said the deficiencies preclude talk of the drugs...

The buzz around Apple Inc.’s (NASDAQ: AAPL) smart-watch debut has been on the rise in past weeks as developers scramble to create apps that will be compatible with the device’s operating system. Biometric apps are expected to be in high demand upon the device’s release, as...