The Latest Breaking News from FDA

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. 

SVB Leerink initiated Selecta Biosciences Inc (NASDAQ:SELB) coverage with an Outperform rating and a price target of $7. The analysts view ImmTOR's approach to mitigate ADAs as de-risked by early clinical data from SEL-212 and believe that the ability to tame the immune response bodes well for ImmTOR's clinical potential in combination with…

Intercept Pharmaceuticals Inc's (NASDAQ:ICPT) pre-submission meeting to discuss the marketing application for obeticholic acid (OCA) in NASH has been moved to July (vs. June scheduling). The update follows a recent request from the FDA that topline data from the REGENERATE reanalysis be provided to the agency for review before the meeting.  SVB Leerink…

Everybody knows what almond, oat, and soy milk are. We don’t need the FDA’s intervention, no matter what the dairy lobby claims.

Adult bed rails have been linked to hundreds of deaths and injuries over the years. The CPSC is starting work on a federal safety standard, nearly a decade after consumer groups asked for one.

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.