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EMA

Showing 15 posts of 383 posts found.

Self-administered Crysvita receives positive CHMP opinion

May 10, 2021
Sales and Marketing CHMP, EMA

Kyowa Kirin’s drug for a rare metabolic bone disease, Crysvita, has received a positive opinion from the EMA’s Committee for …

News
GSK building

EMA begin review of GSK & Vir COVID-19 treatment

May 10, 2021
Sales and Marketing COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir

The EMA has begun a rolling review of GSK and Vir’s sotrovimab treatment for COVID-19, which will continue until there …

News
janssen_latest_logo_on_sign

Janssen submits MAA to EMA for novel CAR-T cell therapy

May 5, 2021
Research and Development EMA, EU, Janssen, multiple myeloma

Janssen have submitted a Marketing Authorisation Application (MAA) to the EMA seeking approval of cilta-cel, an investigational B cell maturation …

News
credit_-_daniel_leal-olivas-afp

LEO Pharma receives positive CHMP opinion for dermatitis treatment

April 26, 2021
Sales and Marketing CHMP, EMA, EU, dermatitis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion …

News

EMA to begin review of GSK and Vir’s COVID-19 treatment

April 16, 2021
Medical Communications COVID-19, EMA, GSK, covid-19 treatment, pharma, pharma news, vir

The EMA have begun a review of GSK and Vir Biotechnology’s investigational COVID-19 antibody (VIR-7831) for patients at high risk …

News

EMA launch investigation into J&J’s COVID-19 vaccine amid US blood clot reports

April 12, 2021
Sales and Marketing COVID-19, EMA, J&J, JJ, Vaccine

The EMA is reviewing reports of rare blood clots in four people in the US who received Johnson & Johnson’s …

News
Roche building

Roche’s SMA treatment Evrysdi approved by European Commission

March 30, 2021
Manufacturing and Production EMA, European Commission, PTC Therapeutics, Roche, sma, spinal muscular atrophy

The European Commission has granted marketing authorisation to Roche and PTC Therapeutics’ Evrysdi, for the treatment of patients aged 2 …

News

Janssen’s multiple sclerosis treatment recommended by EMA

March 29, 2021
Sales and Marketing CHMP, EMA, Janssen, Johnson & Johnson, PONVORY, multiple sclerosis

Janssen’s PONVORY therapy for the treatment of adults with relapsing forms of multiple sclerosis (MS) has been recommended by the …

News
credit_-_daniel_leal-olivas-afp

Astellas Pharma and Seagen cancer treatment gets MAA acceptance from EMA

March 26, 2021
Medical Communications EMA, oncology

Astellas Pharma and Seagen Inc. have announced that the EMA has accepted their marketing authorisation application (MAA) for enfortumab vedotin, …

News
stock-incyte-01-shutter

Incyte biliary tract cancer treatment approved in Japan

March 23, 2021
Manufacturing and Production EMA, Japan, oncology

The Japanese Ministry of Health, Labour, and Welfare (MHLW) have approved Incyte’s Pemazyre (pemigatinib) for the treatment of patients with …

News

AstraZeneca COVID-19 vaccine deemed “safe and effective” by EMA

March 19, 2021
Medical Communications AstraZeneca, COVID-19, EMA, Vaccine

AstraZeneca’s COVID-19 vaccine has been cleared for continued use by the EMA following an investigation into the reports of 37 …

News
astrazeneca_sign_sky

Netherlands suspends AstraZeneca vaccine despite safety assurances

March 15, 2021
Medical Communications, Sales and Marketing AstraZeneca, COVID-19, EMA, EU, WHO

The Netherlands has become the latest country to suspend the use of the Oxford-AstraZeneca vaccine amid concerns it may cause …

News

J&J’s one-shot COVID-19 vaccine approved by European Commission

March 12, 2021
Medical Communications COVID-19, EMA, Johnson & Johnson

The European Commission has granted Johnson and Johnson’s single-shot COVID-19 vaccine Conditional Marketing Authorisation (CMA), it was announced on Thursday. …

News
credit_-_daniel_leal-olivas-afp

CHMP recommends Lilly’s bamlanivimab for COVID-19 patients

March 8, 2021
Sales and Marketing COVID-19, EMA, Eli Lilly

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive scientific opinion for Eli Lilly’s bamlanivimab …

News

Ipsen receives CHMP recommendation for Cabometyx in combination with Opdivo

March 1, 2021
Sales and Marketing Cancer, EMA, ipsen

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval for Ipsen’s Cabometyx (cabozantinib) in combination with …

News

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