Pharma News - Chemdiv

France to see record of more than 350,000 new COVID infections Tuesday - minister

France's health ministry will announce later on Tuesday a record of more than 350,000 new COVID infections over a 24-hour period, Health Minister Olivier Veran told lawmakers. ...

COUR Pharmaceuticals Receives FDA Fast Track Designation for CNP-104 for the Treatment of Primary Biliary Cholangitis

COUR Pharmaceuticals, a biotechnology company developing novel immune-modifying nanoparticles (CNPs) to treat immune disorders, today announced the U.S. Food and Drug Administration (FDA) granted F...

Idorsia's insomnia drug gets U.S. FDA approval

Swiss drugmaker Idorsia (IDIA.S) said on Monday it has received the U.S. Food and Drug Administration's approval for its treatment for insomnia in adult patients. ...

Mystery brain illness baffles Canadian doctors as cases continue to spread among young people

A mystery brain illness that is baffling Canadian doctors is increasingly affecting young people, a doctor has claimed.

FDA Grants ILiAD Biotechnologies Fast Track Designation for Next Generation Pertussis Vaccine BPZE1

ILiAD Biotechnologies, a late stage biotech development company focused on global eradication of disease due to Bordetella pertussis, today announced that the U.S. Food and Drug Administration (FD...

FDA Approves Two Pediatric Indications For J&J’s Xarelto

Xarelto now has 11 indications in the US, the most of any direct oral anticoagulant (DOAC), and is the most studied oral FactorXa inhibitor in its class.

New blood test can identify presence of cancer

The test is a technological first in determining the metastatic status of a cancer without using prior insight of the primary cancer presented.

FDA expands EUA of Pfizer-BioNTech’s Covid-19 booster shot to adolescents

FDA amended the EUA to reduce the time between the completion of the initial dosing regimen and booster shot to five months.

FDA grants Fast Track status to Genprex’s drug for NSCLC treatment

In preclinical studies, Reqorsa plus Keytruda were found to be efficient versus Keytruda alone in boosting survival.

U.S. Reports Record 1 Million Coronavirus Cases in a Single Day

The record comes after a holiday weekend, so a backlog of cases likely contributed to the number.

LEO Pharma’s Eczema Drug Wins FDA Approval

With 2021 nearly over, LEO Pharma has scored a big victory with Adbry (tralokinumab-ldrm), earning the FDA’s blessing for treating moderate-to-severe eczema (atopic dermatitis). The approval mark...

Viona Recalls 33 Lots of Diabetes Drug Due to Possible NMDA Contamination

Viona Pharmaceuticas is recalling 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg, because of potential contamination by N-nitrosodimethylamine (NDMA), a likely carcinogen.

Pharma News, 2022