Pharma News - Chemdiv

Fujirebio’s Diagnostic Test for Beta-amyloid Plaques Given FDA OK

The U.S. Food and Drug Administration (FDA) has granted marketing permission to a new test that checks for amyloid plaques in people being checked for Alzheimer’s disease. ...

Flu causes cardiac complications by directly infecting the heart

Researchers have shown for the first time in mice that heart problems associated with the flu are not caused by raging inflammation in the lungs, as has long been predicted. ...

NICE Recommends Gedeon Richter’s Ryeqo for Uterine Fibroids

The UK’s National Institute for Health and Care Excellence (NICE) is recommending Gedeon Richter’s Ryeqo (relugolix, estradiol and norethisterone acetate) for National Health Service use for t...

Lilly’s new drug Mounjaro (tirzepatide ) wins US FDA approval

Blood sugar control drug Mounjaro has been granted US regulatory approval, giving type 2 diabetics another way to help keep their glucose levels in check.

Aurobindo Gets Hit With Another Form 483

Aurobindo Pharma has taken another hit from the FDA after an inspection of its oral drug manufacturing facility in Hyderabad, India, earlier this month resulted in a Form 483 report with six observ...

UCB Psoriasis Drug Will Need to Wait for US Approval

It won't be a happy weekend for UCB as the U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to the Belgium-based company regarding its Biologics License Application (BLA) f...

PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE®

PolarityTE, Inc. (Nasdaq: PTE) today announced that the U.S. Food and Drug Administration (FDA) granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company's op...

FDA Approves Oral Form for the treatment of adults with amyotrophic lateral sclerosis (ALS)

FDA has approved Radicava ORS (edaravone) oral suspension for the treatment of adults with amyotrophic lateral sclerosis (ALS).

New data reinforces AstraZeneca and Sanofi’s nirsevimab as effective RSV immunisation

Nirsevimab is the first investigational immunisation designed to protect all infants across the RSV season with a single dose.

FDA Delays PDUFA Date for Amicus’ AT-GAA Therapy

The FDA has extended by 90 days its Prescription Drug User Fee Act (PDUFA) decision dates for Amicus Therapeutics’ AT-GAA dual therapy, which includes a Biologics License Application (BLA) for c...

Stealth BioTherapeutics Receives Orphan Drug Designation from FDA for Elamipretide for Treatment of Duchenne Muscular Dystrophy

Stealth Biotherapeutics Corp (Nasdaq: MITO), a clinical-stage biotechnology company focused on the discovery, development, and commercialization of novel therapies for diseases involving mitochond...

Common steroids after 'long COVID' recovery may cut risk of death by up to 51%

Evidence continues to gather that "long COVID," that is, continued negative health impacts months after apparent recovery from severe COVID-19, is an important risk for some patients. ...