Social Media Ideas for European Medicines Agency

<![CDATA[EMA’s CHMP Recommends Eli Lilly’s Jaypirca for Approval]]>

On second try, Acadia drug gets nod from European regulators

The influential CHMP committee also threw its support behind more than a dozen other medicines while recommending the marketing authorization for Tavneos be revoked.

<![CDATA[FDA Advisory Committee Votes Unanimously in Favor of the Benefit-Risk Profile of mRNA-1010 ]]>

<![CDATA[FDA Issues CRL to Elevar Therpaeutics for Combination of Rivoceranib and Camrelizumab ]]>

How long do Europeans have to wait for new pharmaceuticals after EMA approval?

The answer is provided by EFPIA’s annual WAIT indicator (press release, report). First, we see a large decrease in the share of pharmaceuticals fully availbity, drive by a small in...

<![CDATA[Pharmaceutical Executive Daily: FDA Issues CRL to Elevar Therapeutics]]>

EMA: Amgen, Vifor Inflammatory Drug’s Benefits No Longer Outweigh Risks

A European Medicines Agency committee now recommends withdrawing marketing authorization for Tavneos, an Amgen drug marketed in Europe by a CSL Limited subsidiary. Meanwhile, an FD...

<![CDATA[Pharmaceutical Executive Daily: FDA Advisory Committee Votes Unanimously in Favor of The Benefit-Risk Profil...

<![CDATA[FDA Sends CRL to Cingulate for CTx-1301]]>

EMA Recommends Generic for Advanced/Metastatic Breast Cancer

By: Sophie Cousins From: medscape.com The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has recommended granting a marketing authorisation for Pa...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Ennumo]]>

<![CDATA[FDA Approves Leqembi Iqlik Subcutaneous Injection for Early Alzheimer’s Disease]]>

UK regulator announces closer ties with Welsh health sector

UK regulator the Medicines and Healthcare products Regulatory Agency (MHRA) announces greater presence in Wales to drive life sciences growth and development.

Approval of Parkinson’s therapy urged in Europe under brand name Hopledo

A European Medicines Agency (EMA) committee is recommending approval of Hopledo (IPX203) — an extended-release formulation of levodopa and carbidopa sold in the U.S. under the bran...

The EU Pharma Package: What U.S. Companies Need to Know

<![CDATA[FDA Pauses Release of New CRL’s Following Citizen’s Petition ]]>

<![CDATA[FDA Advisory Panel to Vote on Composition of Covid-19 Vaccines for 2026-2027 ]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Datroway]]>

Enhertu approved in the EU as first tumour agnostic HER2-directed therapy and antibody drug conjugate for patients with...

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as a monotherapy for the treatment of adult patients with unrese...

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Sends Complete Response Letter for Cingulate's CTx-1301]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Xocova]]>

Μας κόβουν τα νέα φάρμακα: Γιατί 3 στα 5 δεν θα έρθουν ποτέ στην Ελλάδα

Η μελέτη-σοκ του ΣΦΕΕ αποκαλύπτει ότι οι Έλληνες ασθενείς έχουν ελεύθερη πρόσβαση μόλις στο 20% των καινοτόμων θεραπειών - Με μέσο χρόνο αναμονής τις 641 ημέρες, οι φαρμακευτικές «...

MHRA issues Tuesday health alert for people taking several common medications

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a health alert warning that hot weather can affect how medicines work