Pharma News - Chemdiv

U.S. says use of Pfizer's COVID-19 antiviral up 315%

Use of Pfizer Inc’s (PFE.N) COVID-19 oral antiviral treatment Paxlovid has jumped 315% over the past four weeks, the U.S. Department of Health and Human Services said on Tuesday, as health offici...

MHRA Approves Verzenios for Certain Types of Early Breast Cancer

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization to Eli Lilly’s Verzenios (abemaciclib) in combination with endocrine therapy for adjuvant...

Evotec, Sernova Striving for Functional Diabetes Cure

Two life sciences powerhouses are coming together to develop an off-the-shelf beta cell replacement therapy for insulin-dependent diabetes patients, which they hope will become a functional cure f...

Otsuka Ends Partnership With Akebia Over CRL-Related CKD Anemia Drug

Otsuka Pharmaceutical said it is ending a collaboration with Akebia Therapeutics over the investigational chronic kidney disease-associated anemia drug vadadustat. ...

NICE Recommends AstraZeneca’s Imfinzi for NSCLC

The UK’s National Institute for Health and Care Excellence (NICE) is recommending AstraZeneca’s Imfinzi (durvalumab) for National Health Service (NHS) use in treating patients with locally adva...

FDA Authorizes First COVID-19 Test Available without a Prescription That Also Detects Flu and RSV

Today, the U.S. Food and Drug Administration authorized the Labcorp Seasonal Respiratory Virus RT-PCR DTC Test for use without a prescription by individuals with symptoms of respiratory viral infec...

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...