The Latest Breaking News from FDA

The US Food and Drug Administration's recent decision to limit the use of the Johnson & Johnson Covid-19 vaccine to adults who cannot or will not get another vaccine will have profound consequences for African countries. The FDA said its move reflected the risk that the vaccine might cause a…

Needham writes that Merus NV (NASDAQ: MRUS) has enough data to initiate an FDA marketing application filing in mid-2022 after presenting Zenocutuzumab (Zeno) data in NRG1-fusion (NRG1+) Cancer. 

The FDA has accepted Quoin Pharmaceuticals Inc's (NASDAQ:QNRX) Investigational New Drug (IND) application for its licensed formulation, which uses Skinvisible Inc's (OTC:SKVI) Invisicare drug delivery technology.  The topical formulation "QRX003" was developed to treat Netherton's Syndrome, a debilitating hereditary disorder that affects the skin, hair, and the immune system. Skinvisible granted Quoin an exclusive, royalty-bearing…

PHILADELPHIA — Zoli’s parents plan to get their 4-year-old son vaccinated against COVID-19 as soon as shots for young children could finally become available later this month.

Industry and federal efforts to alleviate a baby formula shortage in the U.S. are ramping up, with the import of foreign brands supplementing increased domestic production.

23andMe (ME) saw its shares slump in price after it reported its fourth-quarter earnings results last month. However, given the company's multiple FDA authorizations for over-the-counter genetic health risk reports, would it be worth scooping up its shares now? Read on, let's find out.

WASHINGTON — A proposed federal ban on menthol cigarettes has underscored the tension lawmakers face in using so-called “sin tax” revenue to fund critical social programs at the state and federal levels.

The company that runs the largest baby formula factory in the US has reopened its plant, but consumers may be waiting months before supply levels return to normal.

The Abbott facility was closed in February after a recall involving bacterial infections in infants which led to a nationwide shortage