Pharma News - Chemdiv

FDA Approves Mallinckrodt's Terlivaz For Injection For Treatment Of Hepatorenal Syndrome

Mallinckrodt plc (MNKPF) said that the U.S. Food and Drug Administration approved Terlivaz (terlipressin) for injection.

A New Covid Variant Is Now Spreading - Omicron BA.4.6

London: BA.4.6, a subvariant of the omicron COVID variant which has been quickly gaining traction in the US, is now confirmed to be spreading in the UK.

Malaria vaccine candidate safe and immunogenic following first-in-human trials

Researchers from the Walter Reed Army Institute of Research (WRAIR) report the malaria vaccine FMP013 antigen and ALFQ adjuvant combination appears safe and immunogenic for adults in the first-in-h...

IMHE Modeling Shows 307 Percent Increase in Long COVID Cases From 2020 to 2021

There was a 307 percent increase in new long COVID cases identified between 2020 and 2021, according to modeling the University of Washington’s Institute for Health Metrics and Evaluation (IMHE)...

aTyr Pharma Receives Fast Track Designation for Efzofitimod

aTyr Pharma received a Fast Track designation for its investigational candidate efzofitimod in the treatment of patients with systemic sclerosis-associated interstitial lung disease. ...

FDA Accepts New Drug Application for Aripiprazole Long-Acting Injectable for Schizophrenia, Bipolar Disorder

The New Drug Application for aripiprazole 2-month, ready-to-use, long-acting injectable could lead to the first FDA approval of a 2-month schizophrenia and bipolar I disorder antipsychotic treatme...

Two FDA Committees to Discuss Perrigo’s Opill Drug for OTC Use

Two FDA committees, the Nonprescription Drugs Advisory Committee and the Obstetrics, Reproductive, and Urologic Drugs Advisory Committee, will be reviewing Perrigo’s Opill (norgestrel tablets) fo...

Pfizer’s Omicron BA.4/BA.5 vaccine recommended by CHMP

Pfizer and BioNTech’s COVID-19 vaccine targeting Omicron BA.4 and BA.5 has been recommended for authorisation by the EMA’s human medicines committee, shortly after the panel gave its blessing ...

FDA and EMA Accept Pfizer Submissions for Ritlecitinib for Alopecia Areata

The FDA and EMA have accepted Pfizer’s New Drug Application (NDA) and Marketing Authorization Application (MAA) for ritlecitinib, both for adults and adolescents 12 years of age and older with al...

$Patients with refractory metastatic colorectal cancer experience survival benefits with fruquintinib$

Patients with refractory metastatic colorectal cancer experience survival benefits with fruquintinib

Researchers from The University of Texas MD Anderson Cancer Center reported study results showing that the targeted therapy fruquintinib significantly improved overall survival (OS) and progression...

FDA nod for Sotyktu in moderate-to-severe plaque psoriasis

The US Food and Drug Administration (FDA) late on Friday announced the approval Sotyktu (deucravacitinib), a first-in-class, oral, selective, allosteric tyrosine kinase 2 (TYK2) inhibitor, for the ...

Intellia’s NTLA-2002 Receives Orphan Drug Designation

Intellia Therapeutics received Orphan Drug designation from the FDA for its investigational candidate NTLA-2002 in the treatment of patients with hereditary angioedema, a disorder characterized by ...

Pharma News, 2022