Pharma News - Chemdiv

FDA approves Pfizer vaccine for emergency use in children aged 5 to 11

The U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 vaccine for emergency use in children aged 5 to 11 on Friday, a critical step toward beginning vaccinations for the age grou...

Omeros Gets FDA Complete Response Letter Over Narsoplimab

Seattle-based Omeros has been hit with a Complete Response Letter (CRL) from the FDA regarding its biologics license application (BLA) for narsoplimab in the treatment of hematopoietic stem cell t...

The FDA authorizes Moderna and J&J COVID vaccine boosters

The Food and Drug Administration authorized booster doses of the COVID-19 vaccines made by Moderna and Johnson & Johnson following unanimous votes by a committee of independent advisers backin...

Sio Gene Therapies Announces Granting of FDA Fast Track Designation for Investigational AXO-AAV-GM1 (AAV9-GLB1) Gene Therapy in Patients with GM1 Gangliosidosis

NEW YORK and DURHAM, N.C., Oct. 21, 2021 (GLOBE NEWSWIRE) -- Sio Gene Therapies Inc. (NASDAQ: SIOX), a clinical-stage company focused on developing gene therapies to radically transform the lives ...

FDA OKs Roche’s Tecentriq for Some NSCLC Patients

Roche’s blockbuster monoclonal antibody Tecentriq (atezolizumab) got another approval from the FDA, this time for certain nonsmall-cell lung cancer (NSCLC) patients.

FDA-approved drug encourages sensory neurons to regrow after injury

A spinal cord injury damages the lines of communication between the body and brain, impeding the signals that drive movement and sensation.

FDA Expected To Approve J&J, Moderna Covid Booster Shots, ‘Mix and Match’ Doses

BALTIMORE (WJZ) — The FDA is expected to give the green light this week to booster shots for those already vaccinated with Moderna and Johnson and Johnson—a huge step in protecting against...

NIH reports interferon is ineffective in hospitalised Covid-19 patients

The National Institutes of Health (NIH) in the US has reported that interferon beta-1a in combination with remdesivir did not boost outcomes in an ACTT-3 clinical trial in hospitalised adult C...

Akero Therapeutics Receives FDA Fast Track Designation for Efruxifermin (EFX) for the Treatment of NASH

SOUTH SAN FRANCISCO, Oct.

Despite legal troubles, Johnson & Johnson is in the financial driver's seat for 2022 and beyond, CFO says

Headlines about its underachieving COVID-19 vaccine, its attempts to resolve opioid and talc litigation and the coming departure of CEO Alex Gorsky suggest that it has been a difficult year for Johnso...

FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ

FDA delays decision on Moderna's COVID-19 vaccine in 12-17 age group because of myocarditis concerns: WSJ After reports in four Nordic countries of the heart inflammation condition myocarditis, th...

Vertex’s type 1 diabetes therapy hits the mark in Phase I/II study

Vertex Pharmaceuticals has revealed ‘remarkable’ data from an early-stage study evaluating its stem-cell derived therapy VX-880 in type 1 diabetes (T1D).