The name's changing, but for investors, little else will. Yesterday, the FDA announced that on Aug. 11 it will finally put the "approvable letter" out of its misery. Loved by short sellers, hated ...

Under a new proposal, the Food & Drug Administration may stop issuing "approvable" and "not approvable" letters to drug sponsors whose applications need to be revised or amended. Instead, companies ...

Approvable letter -- that sounds pretty good, right? Like, basically, something is on the verge of a green light? Not if you get one from the FDA about a drug you hope to market.

Not so. In FDA-speak, an "approvable letter" actually is a rejection, telling the company it fell short of its burden to prove a drug's safety and effectiveness but it can keep trying.

Neurocrine Biosciences Inc <NBIX.O> said on Thursday that it has received an approvable letter from the U.S. Food and Drug Administration for its experimental sleep drug indiplon capsules.

Says received approvable letter for MelaFind Says will work with FDA to answer questions Shares up 129 pct in pre-market trade (Adds details in paragraphs 3-6 and share movement) Sept 26 (Reuters ...

BioWorld - Friday, October 27, 2023 See today's BioWorld Home » ViroPharma Prepares To Receive Not Approvable' Picovir Letter Upgrade your daily dose of biopharma and medtech news Subscribe to ...

The article Approvable, Just Not Approved originally appeared on Fool.com. Fool contributorBrian Orelliholds no position in any company mentioned. Check out hisholdings and a short bioMotley Fool ...

The article Approvable, Just Not Approved originally appeared on Fool.com. Fool contributorBrian Orelliholds no position in any company mentioned. Check out hisholdings and a short bioMotley Fool ...

The letter states that ThinPrep, which assists with cervical cancer screening, is approvable pending the FDA's inspection of Cytyc's manufacturing facility. The stock is off 2 cents to $10.