Palobiofarma Receives Rare Pediatric Disease Designation from the U.S. FDA for PBF-999 for the Treatment of Prader-Willi Syndrome

by Palobiofarma

1 year ago
Palobiofarma, Rare Pediatric Disease (RPD) Designation, FDA, Prader-Willi Syndrome

Palobiofarma has announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) Designation for the company’s phosphodiesterase 10 (PDE-10) inhibitor, PBF-999, f...

Oncoheroes Biosciences and Allarity Therapeutics Sign Exclusive Pediatric Licensing Agreement for Dovitinib and Stenoparib

by Oncoheroes Biosciences

3 years ago
Allarity Therapeutics, Oncoheroes Biosciences, FDA, Stenoparib, Dovitinib, children’s cancer

Oncoheroes Biosciences, Inc. (“Oncoheroes”), and Allarity Therapeutics, Inc. (Nasdaq: ALLR) (“Allarity”) have signed a worldwide, exclusive pediatric licensing agreement for dovitinib, a pan-t...

LA EMA rechaza la aprobación en Europa de aducanumab

by Fundación Pasqual Maragall

3 years ago
FDA, Alzheimer, aducanumab, EMA

En junio, la FDA, responsable de la regulación de fármacos en Estados Unidos, decidió aprobar, en medio de una polémica, la comercialización de aducanumab, un fármaco con posibles efectos modifi...

La FDA aprueba el primer tratamiento farmacológico dirigido contra tumores pulmonares con mutaciones en el gen KRAS

by Revista Genética Médica

3 years ago
terapias farmacológicas, FDA, cáncer de pulmón

El pasado 28 de mayo, la Administración de Medicamentos y Alimentos de los Estados Unidos (FDA, por sus siglas en inglés) aprobó la primera terapia dirigida para cáncer de pulmón en pacientes con...

Drugs approved by the FDA in 2020 reflect continuing trend of structural innovation

by CAS, a division of the American Chemical Society

4 years ago
oncology, drugs, FDA, pharmaceutical industry, molecular shape

New drug innovation remained strong in 2020. The total of 53 drugs approved represented the second-highest number of approvals in more than two decades, a positive indicator of productivity in the pha...

EEUU autoriza el ensayo de un medicamento con células madre de cordón umbilical para tratar la artritis reumatoide

by Secuvita

4 years ago
Baylx, FDA, medicamento, células madre, cordón umbilical, artritis reumatoide

La Administración de Alimentos y Medicamentos de los Estados Unidos (FDA) ha aprobado la investigación con un fármaco con células madre mesenquimales de cordón umbilical para tratar la artritis r...

Life cycle in process validation. Continued Process Verification

by Telstar

5 years ago
pharmaceutical industry, life cycle, FDA

This article introduces the concept of life cycle applied to process validation and how this idea was already underlying the first FDA reports on the challenges that the pharmaceutical industry had to...

The FDA licenses Chemotargets CLARITY platform

by IMIM - Institut Hospital del Mar d'Investigacions Mèdiques

5 years ago
FDA, Chemotargets, drugs, molecular

Chemotargets -a global leader in the development of intelligence platforms and drug design prediction, headquartered in the Barcelona Science Park- has signed a license agreement for its CLARITY® pla...

NDMA | Ranitidine medicines

by Asphalion

5 years ago
Ranitidine, FDA, medicines, stomach acid

In September 2019, the European Commission (EC) requested EMA to start a review of ranitidine medicines after tests showed that some of these products contained the impurity N-nitrosodimethylamine (ND...

Grifols announces collaboration with US Government for a treatment against Covid-19

by CataloniaBio

5 years ago
Grifols, plasma, covid-19, infectious diseases, FDA

Grifols, a CataloniaBio & HealthTech member, has entered into a formal collaboration with the Food and Drug Administration (FDA) and other public health agencies of United States to collect plas...

Approval review of pemigatinib for patients harbouring FGFR2 fusions

by OncoDNA

5 years ago
fibroblast, liver, FDA, pemigatinib

The FDA have granted priority approval review of pemigatinib for patients harbouring FGFR2 fusions, based on interim data from the phase II FIGHT-202 study showing ORR 36%

VHIO investigators establish ‘user-friendly’ criteria to capture hyperprogression in patients treated with immune checkpoint inhibitors

by VHIO

5 years ago
La Caixa, FDA, hyperprogression, immune checkpoint

While cancer immunotherapy continues to show promise in improving outcomes for patients across several tumor types, we must collectively strive to potentiate and personalize this armory to successfull...