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(Eng) FDA Issues Decisions on Additional E-Cigarette 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 took additional actions as part of the agency’s work to ensure any electronic nicotine [...]

(Eng) EMA recommends authorisation of COVID-19 medicine Evusheld

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 granting a marketing authorisation for Evusheld, developed by AstraZeneca AB, for the prevention of COVID-19 in [...]

(Eng) FDA Approves First Generic of Symbicort to Treat Asthma and COPD

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 generic of Symbicort (budesonide and formoterol fumarate dihydrate) Inhalation Aerosol for [...]

(Eng) FDA Approves Treatment for Wider Range of Patients with Heart Failure

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 Jardiance (empagliflozin) to reduce the risk of cardiovascular death and hospitalization for heart [...]

(Eng) EMA recommends authorisation of booster doses of Comirnaty from 12 years of age

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 that a booster dose of the COVID-19 vaccine Comirnaty may be given where appropriate [...]

(Eng) EMA recommends approval of Spikevax for children aged 6 to 11

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 granting an extension of indication for the COVID-19 vaccine Spikevax to include use in children aged [...]

(Eng) EMA: New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma

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 granting a marketing authorisation in the EU for Breyanzi (lisocabtagene maraleucel), a gene therapy for the treatment of adult patients [...]

(Eng) EMA: Increase in manufacturing capacity for Vaxzevria (previously COVID-19 Vaccine AstraZeneca)

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 approved a scale up of manufacturing of Vaxzevria (previously COVID-19 Vaccine AstraZeneca). An existing manufacturing [...]

(Eng) EMA: Preliminary data indicate COVID-19 vaccines remain effective against severe disease and hospitalisation caused by the Omicron variant

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 continues to monitor emerging data on the effectiveness of vaccines against COVID-19, including disease caused by the Omicron variant which [...]

Infarmed: Vacinas COVID-19 continuam eficazes contra doenças graves e hospitalização causadas pela variante Omicron

A Agência Europeia de Medicamentos (EMA na sigla em inglês) continua a monitorizar os dados sobre a eficácia das vacinas contra a COVID-19, incluindo a doença causada pela variante Omicron. Embora a variante Omicron pareça ser mais infeciosa do que outras variantes, os estudos realizados em alguns países, nomeadamente, África do Sul, Reino Unido e [...]

ANSM: Traitement curatif contre le Covid-19: un nouvel anticorps monoclonal dans l’arsenal thérapeutique

Dans le contexte d’émergence de nouveaux variants du Covid-19, nous restons mobilisés pour permettre aux patients un accès le plus précoce possible aux traitements innovants. A ce titre, nous avons participé au niveau européen à l'évaluation de la monothérapie par anticorps monoclonal Xevudy (sotrovimab, GSK) qui a obtenu une autorisation de mise sur le marché (AMM) européenne [...]

(Eng) EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19

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 started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is [...]

(Eng) FDA Shortens Interval for Booster Dose of Moderna COVID-19 Vaccine to Five Months

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 amended the emergency use authorization (EUA) for the Moderna COVID-19 Vaccine to shorten the [...]

(Eng) FDA Takes Multiple Actions to Expand Use of Pfizer-BioNTech COVID-19 Vaccine

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 amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine to: Expand the [...]

(Eng) UK MHRA: Oral COVID-19 antiviral, Paxlovid, approved by UK regulator

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 new combination treatment is for people with mild to moderate COVID-19 who are at high risk of developing severe COVID-19 [...]

(Eng) FDA Authorizes Additional Oral Antiviral for Treatment of COVID-19 in Certain Adults

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 issued an emergency use authorization (EUA) for Merck’s molnupiravir for the treatment of mild-to-moderate coronavirus disease [...]

(Eng) FDA Authorizes First Oral Antiviral for Treatment of COVID-19

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 issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and ritonavir tablets, co-packaged for [...]

(Eng) FDA Grants Marketing Authorization for Inferior Vena Cava Filter Removal Device

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 marketing of the first laser-based device for the removal of Inferior Vena Cava [...]

AEMPS: La EMA recomienda la autorización de la quinta vacuna frente a la COVID-19

La vacuna desarrollada por Novavax previene la enfermedad causada por SARS-CoV-2 en personas a partir de 18 años y es la primera basada en una plataforma de proteínas recombinantes La Comisión Europea ahora otorgará la autorización de comercialización condicional para que pueda distribuirse en todos los Estados miembro de la UE Las reacciones adversas observadas [...]

(Eng) FDA Approves First Injectable Treatment for HIV Pre-Exposure Prevention

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 Apretude (cabotegravir extended-release injectable suspension) for use in at-risk adults and adolescents weighing [...]

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