The Latest Breaking News from FDA

The FDA is approving more drugs that haven’t been shown to work. Are patients being harmed?

LOS ANGELES — Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.

Los Angeles Times · Mar 4, 2022

FDA Denies Pediatric EUA To Ocugen For Bharat Biotech's COVID-19 Vaccine Covaxin

The FDA has declined to issue an Emergency Use Authorization (EUA) for Covaxin for active immunization to prevent COVID-19 in individuals 2 to 18 years of age. Ocugen Inc (NASDAQ:OCGN) is working with the vaccine's developer, Bharat Biotech of India, to bring Covaxin to the U.S. Related: FDA Lifts Clinical Hold On Ocugen's COVID-19…

Benzinga · Mar 4, 2022

Why Ocugen Shares Are Falling

Ocugen Inc (NASDAQ: OCGN) shares are trading lower by 22.8% at $2.54 after the company announced the FDA declined to issue an EUA for COVAXIN for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 2 to 18 years of age.

Benzinga · Mar 4, 2022

WHO Conditionally Recommends Merck's COVID-19 Antiviral Pill For High-Risk Patients

A World Health Organization (WHO) panel has backed the use of Merck & Co Inc's (NYSE:MRK) COVID-19 antiviral pill for high-risk patients. The expert panel conditionally recommended molnupiravir for patients with non-severe disease at high risk of hospitalization, such as the immunocompromised, the unvaccinated, older people, and those with chronic conditions. The recommendation was…

Benzinga · Mar 3, 2022

AVITA Medical Inks Supply Pact With Premier For RECELL System

AVITA Medical Inc (NASDAQ:RCEL) has been awarded a group purchasing agreement with Premier Inc (NASDAQ:PINC) The new agreement allows Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for the RECELL System for the treatment of adult and pediatric patients with severe burns.  The RECELL System is a…

Benzinga · Mar 3, 2022

Reports of infant illnesses investigated following US formula recall

FDA and CDC urge parents to avoid feeding babies formula produced at Michigan facility operated by Abbott Nutrition

The Guardian - US · Mar 3, 2022

LSD And Magic Mushroom's Active Compound Appear To Have The Same Effects, New Study Finds

A new peer-reviewed study compared the effects of LSD and psilocybin, two substances currently standing as top molecules behind the recent psychedelic medicine boom. While both compounds have a rich history of human use, not much research has been dedicated to contrasting the effects they produce in human psychology. The…

Benzinga · Mar 3, 2022

Abbott facing lawsuits, FDA investigation over recalled infant formula after reports of illness, death

Parents who bought recalled infant formulas made by Abbott Laboratories are filing proposed class-action lawsuits against Abbott, as the U.S. Food and Drug Administration investigates reports of three babies who became sick and two who died after consuming the formulas.

Chicago Tribune · Mar 2, 2022

CBD In Children: Poll Finds Over One-Third Of Parents Think Consuming CBD Is Same As Cannabis, What About FDA?

About 80% of parents confirmed they know little to nothing about CBD use in children, according to a recent poll by the Universit

Benzinga · Mar 2, 2022

Sensus Healthcare Offloads Sculptura Assets To Focus On Core Dermatology Offerings

Sensus Healthcare Inc (NASDAQ:SRTS) sold its Sculptura assets to Empyrean Medical Systems for $15 million in cash.  The sale included an inventory of Sculptura systems and parts, in addition to all related intellectual property. The Sculptura system provides targeted Directional Anisotropic Radiation Therapy (ART) and brachytherapy utilizing proprietary, state-of-the-art 3D Beam Sculpting to treat…

Benzinga · Mar 2, 2022