The Latest Breaking News from FDA

The Biden administration signaled that it would develop a proposed rule to establish a maximum nicotine level to reduce the addictiveness of cigarettes and certain other combusted tobacco products. The goal of the potential rule would be to reduce youth use, addiction, and death. 

The Biden administration wants to make the tobacco industry cut back the amount of addictive nicotine allowed in cigarettes sold in the U.S.

Gainers Convey Health Solutions Holdings, Inc. (NYSE: CNVY) shares jumped 138.4% to close at $10.30 as the company agreed to be taken private by TPG Capital.

Experts explain how the drug works, where it came from, and what kinds of side effects to expect

Ionis (NASDAQ: IONS) announced that Eplontersen met co-primary and secondary endpoints in interim analysis of the Phase 3 NEURO-TTRansform study for hereditary transthyretin-mediated amyloid polyneuropathy (ATTRv-PN) Ionis shares are trading low 4 percent at $35.10 in the after-hours session

Paratek Pharmaceuticals, Inc. (NASDAQ: PRTK) received Fast Track designation from the U.S.

Kiromic BioPharma Inc (NASDAQ:KRBP) has announced a strategic pipeline shift to prioritize its allogeneic, non-engineered off-the-shelf product candidate, Deltacel/KB-GDT. Kiromic expects to submit its first new investigational new drug (IND) application to the FDA in 2H of 2022.  The IND will seek to evaluate Deltacel in combination with a standard antitumor modality, with…

The FDA issued a Complete Response Letter regarding the marketing application for Acer Therapeutics Inc (NASDAQ:ACER) and its collaboration partner, Relief Therapeutics Holding SA's (OTC:RLFTF) ACER-001 (sodium phenylbutyrate), for urea cycle disorders (UCDs). The CRL states: "[The FDA's] field investigator could not complete inspection of [Acer's third-party contract packaging manufacturer] because the facility was not ready…

The U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Acer Therapeutics’ (NASDAQ: ACER) New Drug Application (NDA) for ACER-001 (sodium phenylbutyrate) for oral suspension in the treatment of patients with urea cycle disorders (UCDs).

Gainers Convey Health Solutions Holdings, Inc. (NYSE: CNVY) shares jumped 138.8% to $10.31 as the company agreed to be taken private by TPG Capital,.

The U.S. Food and Drug Administration (FDA) cleared Nuvectis Pharma’s (NASDAQ: NVCT) Investigational New Drug Application (IND) for NXP800, which includes the Phase 1 clinical trial protocol.