Pharma News - Chemdiv

Top five FDA dermatology approval stories of 2021

The FDA approved many new drugs and technologies over the past year, and in the dermatology world those approvals included treatments for a multitude of conditions. ...

Generic Version of Sanofi-Aventis’ Multaq Gets Tentative Approval

Alembic Pharmaceuticals has gotten tentative approval for its abbreviated new drug application (ANDA) for dronedarone, a generic equivalent to Sanofi-Aventis’ anti-arrhythmic Multaq, which the FD...

In 1st, US surgeons transplant pig heart into human patient

In a medical first, doctors transplanted a pig heart into a patient in a last-ditch effort to save his life and a Maryland hospital said Monday that he’s doing well three days after the highly e...

Free AI protein software packages nearly predicted structure of the Omicron coronavirus variant correctly

Using two different free protein-predicting AI algorithms, computer scientists were almost able to model Omicron before the coronavirus variant had been physically mapped. ...

Future of Biogen's Aduhelm hinges on U.S. Medicare Alzheimer's coverage

The future of Aduhelm, Biogen Inc's (BIIB.O) controversial and expensive Alzheimer's drug, may hinge on a decision due this week from the U.S. Medicare program on whether it will pay for the treatm...

Amgen Nabs EU Approval for Lumykras for Treating KRAS-Mutated Lung Cancer

Amgen’s Lumykras (sotorasib) — branded as Lumakras in the U.S. — has won conditional marketing approval in Europe for treating adults with KRAS G12C-mutated nonsmall-cell lung cancer (NSCLC) ...

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.