The Latest Breaking News from FDA

Q&A: I’m eligible for a second COVID-19 booster shot. Should I get it?

So you took the first COVID-19 vaccine that was offered to you and — if it was one of the two mRNA vaccines available in the U.S. — you went back on schedule to get the second jab. When the Centers for Disease Control and Prevention recommended a booster shot,…

Los Angeles Times · Mar 31, 2022

FDA Warns CBD Companies To Stop Claiming Their Products Can Treat COVID-19

The FDA issued a letter warning seven CBD companies to re

Benzinga · Mar 31, 2022

Clovis Oncology's Rubraca Significantly Improves PFS In Ovarian Cancer Regardless Of Biomarker Status

Clovis Oncology Inc (NASDAQ:CLVS) announced positive topline data from the monotherapy arm of Phase 3 ATHENA-MONO trial of Rubraca (Rucaparib) as first-line maintenance treatment in ovarian cancer. Rubraca achieved the primary endpoint of significantly improved progression-free survival (PFS) compared with placebo (20.2 months vs. 9.2 months). The median PFS for the HRD-positive patient…

Benzinga · Mar 31, 2022

FDA panel narrowly sides against experimental ALS drug

Federal health advisers have narrowly ruled against an experimental drug for the debilitating illness known as Lou Gehrig’s disease

The Independent UK · Mar 30, 2022

FDA Rejects Akebia Therapeutics' Vadadustat For CKD-Associated Anemia

The FDA has issued a complete response letter (CRL) to Akebia Therapeutics Inc's (NASDAQ:AKBA) marketing application (NDA) for vadadustat for anemia due to chronic kidney disease (CKD).  Vadadustat is an investigational oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. The FDA issues a CRL to indicate that the review cycle for an application is complete…

Benzinga · Mar 30, 2022

EMA Starts Review Of Sanofi-GlaxoSmithKline's COVID-19 Vaccine

The European Medicines Agency has started reviewing Sanofi SA (NASDAQ:SNY) and its partner GlaxoSmithKline Plc's (NYSE:GSK) application seeking conditional authorization for their COVID-19 vaccine. The vaccine candidate, Vidprevtyn, was already being evaluated under a rolling review by EMA. The drugmakers had earlier said that they would seek regulatory approval for their COVID-19 vaccine to be…

Benzinga · Mar 30, 2022

5 Healthcare Stocks Likely to Withstand a Recession

The healthcare industry has attracted massive investor interest since the onset of the COVID-19 pandemic and could remain in the limelight as COVID cases surge again and necessitate the need for more COVID shots. In addition, the healthcare sector is known to withstand recessions relatively well. So, with several analysts…

StockNews.com · Mar 30, 2022

Ketamine Wellness Centers Offering FDA Approved Esketamine Treatment For Major Depressive Disorder

Ketamine Wellness Centers subsidiary of Delic Holdings Corp (OTCQB: DELCF) (CSE:DELC) (FRA:6X0), has expanded its treatment options to include SPRAVATO nasal spray. The KWC clinics located in Houston, Las Vegas and Seattle will be offering this treatment option beginning April 1.

Benzinga · Mar 30, 2022

Adagio's COVID-19 Antibody Meets Primary Goals Across Pre & Post-Exposure Prophylaxis, Treatment

Adagio Therapeutics Inc's (NASDAQ:ADGI) Phase 2/3 trials evaluating 300 mg adintrevimab (ADG20) as pre-and-post-exposure prophylaxis (EVADE) and treatment (STAMP) for COVID-19 have met its primary endpoints. Following the emergence of the omicron variant, a pre-specified exploratory analysis in a subset of the pre-exposure cohort, adintrevimab exhibited a clinically meaningful reduction in cases…

Benzinga · Mar 30, 2022

FDA Says Yes To Testing Receptor Life's Dry Power Inhaled CBD To Treat Social Anxiety Disorder

The FDA accepted Receptor Life Sciences’ investigational new drug application for RLS103. RLS103, a dry powder inhaled CBD, which is a first-in-class drug/device combination product for the acute treatment of social anxiety disorder.

Benzinga · Mar 30, 2022