The FDA has approved the combination of Rybrevant plus Lazcluze for first-line treatment of adult patients with locally advanced or metastatic non-small-cell lung cancer, or NSCLC, with epidermal ...

Dr. Jeffrey Barke, a California primary care physician, said the FDA had no right to grant emergency use authorization because the public health emergency declared for the pandemic expired in May ...

What is an FDA Calendar? Biotech investing is risk-fraught, as stocks are at the mercy of several catalysts – most of which are make-or-break events, aka binary events. A prudent investment ...

The FDA green light comes after an advisory committee in June unanimously recommended that manufacturers develop updated Covid vaccines for this fall. Based on the evidence at the time ...

Cresilon has raised about $130 million in venture capital dollars and grown to comprise more than 80 employees — and last week, the company nabbed its second FDA clearance for human use.

The U.S. Food and Drug Administration (FDA) has approved updated COVID-19 vaccines from Moderna and Pfizer for the 2024-2025 season. The updated mRNA vaccines, Comirnaty and Spikevax, were fully ...

There is an opportunity to fix this by encouraging regulators such as the FDA and the EMA to agree on an aligned regulatory approach to the development of complex generics. In 2021, the FDA and ...

The Food and Drug Administration (FDA) approved updated COVID shots from Pfizer and Moderna Thursday, setting the stage for a vaccine rollout in the coming weeks. “In June, the FDA asked that ...

The FDA on Thursday said its marketing authorization of the product was its first ever for a over-the-counter hearing aid software device. Related Apple to release AirPods with built-in hearing ...

“We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said FDA vaccine chief Dr ...

Millions of updated COVID-19 vaccines will soon be ready for patients following Food and Drug Administration approval announced on Thursday. The updated vaccines from Pfizer and Moderna for people ...

“We strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants,” said FDA vaccine chief Dr ...