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(Eng) FDA Approves New Opioid for Intravenous Use in Hospitals, Other Controlled Clinical Settings

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Olinvyk (oliceridine), an opioid agonist for the management of moderate to severe acute [...]

(Eng) FDA Approves First Liquid Biopsy Next-Generation Sequencing Companion Diagnostic Test

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved the first liquid biopsy companion diagnostic that also uses next-generation sequencing (NGS) technology [...]

(Eng) FDA Approves Oral Treatment for Spinal Muscular Atrophy

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The U.S. Food and Drug Administration today approved Evrysdi (risdiplam) to treat patients two months of age and older with spinal muscular [...]

(Eng) FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration authorized the first two COVID-19 serology tests that display an estimated quantity of antibodies [...]

(Eng) FDA Approves New Indication for Drug Containing an Active Ingredient Derived from Cannabis to Treat Seizures in Rare Genetic Disease

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous [...]

(Eng) UK MHRA: New synthetic datasets to assist COVID-19 and cardiovascular research

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.The Medicines and Healthcare products Agency (MHRA) has announced the creation of two innovative synthetic datasets which will support the development of cutting-edge [...]

(Eng) FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new [...]

(Eng) FDA Approves First Cell-Based Gene Therapy For Adult Patients with Relapsed or Refractory MCL

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration approved Tecartus (brexucabtagene autoleucel), a cell-based gene therapy for treatment of adult patients diagnosed [...]

(Eng) EMA: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 20-23 July 2020

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Eleven new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended eleven medicines for approval at its July 2020 meeting, [...]

(Eng) EMA: Panexcell Clinical Laboratories: suspension of medicines over flawed studies

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.EMA’s human medicines committee (CHMP) has recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories Priv. Ltd at its [...]

(Eng) EMA: Vaginal ring to reduce the risk of HIV infection for women in non-EU countries with high disease burden

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.EMA’s human medicines committee (CHMP) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of [...]

(Eng) EMA: Authorised uses of cancer medicine Yondelis unchanged following review of new data

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.EMA has recommended that the use of Yondelis (trabectedin) in treating ovarian cancer remain unchanged following a review of a study that [...]

(Eng) FDA Proposes New Rule on Reporting Requirements

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration published the proposed rule, Annual Summary Reporting Requirements Under the Right to Try Act, that [...]

(Eng) FDA Extends Enforcement Discretion Policy for Certain Regenerative Medicine Products

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration is extending the enforcement discretion policy for certain human cell, tissue, and cellular and [...]

(Eng) FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.Today, the U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR [...]

La AEMPS presenta su Memoria Anual de Actividades 2019

El documento refleja, de una forma global, los procesos desempeñados en la AEMPS durante el año 2019. Al cierre de dicho año, se habían autorizado en España más de 18000 medicamentos, y solo en 2019, la AEMPS autorizó 1357 fármacos de uso humano y 109 de uso veterinario. El Reglamento delegado (UE) 2016/161, sobre dispositivos [...]

(Eng) WHO Pharmaceuticals Newsletter (No.3, 2020)

Disculpa, pero esta entrada está disponible sólo en Inglés Estadounidense. For the sake of viewer convenience, the content is shown below in the alternative language. You may click the link to switch the active language.This edition of the Newsletter also includes three short articles, on: the WHO Vaccine Safety Net, a working group meeting on [...]

ANSM – COVID-19: octroi d’une ATU de cohorte pour le médicament remdesivir, afin que les patients puissent continuer à en bénéficier en France

Pour permettre la continuité de l’accès au médicament antiviral Remdesivir sur le territoire national, l’ANSM vient d'octroyer une autorisation temporaire d’utilisation de cohorte (ATUc). Ainsi, sur la base d’une décision collégiale au niveau hospitalier, des patients atteints de la maladie COVID-19 pourront recevoir ce traitement. Cette décision fait suite à l’avis favorable  de l’Agence européenne des [...]