The Latest Breaking News from FDA

FDA Official Says Frequent COVID-19 Booster Shows Not Sustainable: WSJ

According to a U.S. health regulator, asking people to get COVID-19 boosters frequently wasn't sustainable because of vaccine fatigue, and authorities needed to develop a long-term strategy for protection against the evolving virus.

Benzinga · Apr 7, 2022

The high-stakes push to get COVID vaccines to young children

The Omicron variant and and anti-vaccine backlash are complicating the effort.

Axios · Apr 7, 2022

These 3 Psychedelic Stocks Will Benefit When The FDA Green-Lights MDMA (Molly, Ecstasy)

What Happened: According to the Multidisciplinary Association of Psychedelic Studies (MAPS), a non-profit organization, the FDA is close to greenlighting MDMA as a treatment for PTSD. MAPS reported positive results from a phase-3 trial testing the efficacy of MDMA-assisted therapy.

Benzinga · Apr 6, 2022

States weigh shielding doctors' COVID misinformation, unproven remedies

The controversy began in September, more than a year into the pandemic, when the Tennessee Board of Medical Examiners issued a warning to doctors in the state: Spreading misinformation about COVID-19 vaccines could land them in big trouble with the board, including the possible revocation of their medical licenses.

Tribune News Service · Apr 6, 2022

Novartis' Breast Cancer PI3K Drug, Scores FDA Approval For Ultra-Rare Indication

The FDA has granted accelerated approval to Novartis AG's (NYSE: NVS) Vijoice (alpelisib) for patients 2 years of age and older with severe manifestations of PIK3CA-Related Overgrowth Spectrum (PROS) who require systemic therapy.

Benzinga · Apr 6, 2022

FDA Approves BioXcel's Igalmi - First Orally Dissolving Sublingual Film For Schizophrenia-Associated Agitation

The 

Benzinga · Apr 6, 2022

Repurposing generic drugs can reduce time and cost to develop new treatments – but low profitability remains a barrier

Discovering new ways to use existing drugs can come about intentionally or by chance.

The Conversation · Apr 6, 2022

The Daily Biotech Pulse: BioXcel's Igalmi Gets FDA Nod, Citius Spikes On Positive Phase 3 Data, Iovance Receives Positive Regulatory Feedback For Skin Cancer Therapy

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

Benzinga · Apr 6, 2022

Iovance Outlines Frontline Melanoma Strategy For Lifileucel / Pembrolizumab Combo Therapy

The 

Benzinga · Apr 6, 2022

Experts eye a new game plan for COVID vaccines

An FDA panel mulls long-term strategy for COVID shots

Axios · Apr 6, 2022