The Latest Breaking News from FDA

Details Of Revive Therapeutics' Update On Bucillamine Phase 3 Trial For COVID Treatment

Revive Therapeutics (OTC: RVVTF) has provided an update on Phase 3 of its Buc

Benzinga · Apr 28, 2022

FDA proposes ban on menthol cigarettes, flavored cigars

WASHINGTON — The Food and Drug Administration on Thursday proposed a long-awaited ban on menthol cigarettes and flavored cigars, targeting products used by more than a third of smokers.

Tribune News Service · Apr 28, 2022

FDA proposes ban on menthol cigarettes

FDA commissioner Robert Califf said these rules "are appropriate for the protection of public health."

Axios · Apr 28, 2022

TransMedics Receives FDA Premarket Approval for OCS™ DCD Heart Indication

TransMedics Group, Inc. (NASDAQ: TMDX) received premarket approval (PMA) from U.S. Food and Drug Administration (FDA) for its OCS™ Heart System in favour of use with organs from donors after circulatory death (DCD).

Benzinga · Apr 28, 2022

Moderna applies for US clearance of COVID shot for young kids

Moderna Inc. applied for emergency use authorization for its COVID-19 vaccine in children from six months to under 6 years old after a successful trial showed two doses generate high levels of antibodies to the virus.

Tribune News Service · Apr 28, 2022

The Daily Biotech Pulse: Moderna Seeks FDA Approval For COVID-19 Shot For Children 2-6, Tax Disclosure For Amgen, Fast Track Tags For SQZ Biotech, Timber Pharma Candidates

Here's a roundup of top developments in the biotech space over the last 24 hours:

Benzinga · Apr 28, 2022

Timber Pharmaceutical Gets FDA Fast Track designation for TMB-001 in Severe Subtypes of Congenital Ichthyosis

Timber Pharmaceuticals, Inc. (NYSE: TMBR)  announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TMB-001 for the treatment of X-linked recessive ichthyosis (XRI) and autosomal recessive congenital ichthyosis lamellar ichthyosis (ARCI-LI).

Benzinga · Apr 28, 2022

FDA proposes ban on menthol cigarettes, flavored cigars - Roll Call

The FDA Thursday proposed a ban on menthol cigarettes and all flavored cigars, a move that could take effect in about a year.

Roll Call · Apr 28, 2022

Moderna seeks to be 1st with COVID shots for littlest kids

Moderna is asking U.S. regulators to open its COVID-19 vaccine to the nation's youngest children

The Independent UK · Apr 28, 2022

Moderna seeks emergency authorization for COVID-19 vaccine in young children

Moderna said last month its vaccine for kids generated a strong immune response.

Axios · Apr 28, 2022