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EMA

Showing 15 posts of 383 posts found.

BridgeBio Pharma shares positive feedback from FDA and EMA for phase 3 trial of infigratinib

September 7, 2023
Research and Development BridgeBio Pharma, EMA, FDA, Musculo-skeletal disorder, achondroplasia, clinical trial

BridgeBio Pharma has announced positive feedback from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) on …

News

Iveric Bio’s marketing authorisation application for avacincaptad pegol accepted by EMA

August 18, 2023
Medical Communications CHMP, EMA, Iveric Bio, MAA, Opthalmology

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the marketing authorisation application (MAA) for avacincaptad pegol …

News
Vaccine image

ViiV Healthcare gains positive CHMP opinion for cabotegravir for HIV prevention

July 24, 2023
Medical Communications CHMP, EMA, HIV, HIV/AIDS, ViiV Healthcare, cabotegravir

GSK has announced that ViiV Healthcare has received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal …

News
Chemotherapy

EMA accepts Astellas’ MAA for Zolbetuximab

July 14, 2023
Medical Communications Astellas, Cancer, EMA, Oncology, zolbetuximab

Astellas Pharma has announced that the European Medicines Agency (EMA) has accepted the company’s marketing authorisation application (MAA) for regulatory …

News

OSE Immunotherapies’ UC drug gets DSMB positive recommendation

July 6, 2023
Research and Development EMA, Gastrointestinal tract, OSE Immunotherapeutics, ulcerative colitis

French biotech company OSE Immunotherapeutics has announced that its Ulcerative Colitis (UC) trial’s Independent Drug Safety Monitoring Board (DSMB) has provided …

News

AstraZeneca’s Soliris given EU CHMP recommendation for marketing authorisation

June 26, 2023
Medical Communications AstraZeneca, CHMP, EMA, Immunology, soliris

UK-based biopharmaceutical company AstraZeneca has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) …

News

CHMP gives positive opinion recommending authorisation to GSK’s CKD drug

June 26, 2023
Medical Communications CKD, EMA, Nephrology

Global biopharmaceutical company GSK has announced that the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) …

News

Is the pharmaceutical sector prepared to face a titanium dioxide ban?

May 19, 2023
Manufacturing and Production ACG, EMA, EU, Titanium Dioxide

Dr Subhashis Chakraborty, head of Global Product Management, ACG Capsules In the wake of the ban on titanium dioxide (TiO2) …

News
Press release

Spanner in the works for Sputnik V as missing data reported

July 13, 2021
Manufacturing and Production COVID-19, EMA, Russia, Vaccine

Developers of Russia’s Sputnik V COVID-19 vaccine have repeatedly failed to present data to regulators, Reuters has reported. Five sources …

News
stock-incyte-01-shutter

CHMP issue positive opinion for Incyte and MorphoSys’ tafasitamab

June 29, 2021
Manufacturing and Production CHMP, EMA, EU, FDA, US

Incyte and MorphoSys have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive …

News
biogen_austria_238

Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar

June 28, 2021
Sales and Marketing EC, EMA, EU, biosimilars

Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has adopted a …

News
credit_-_daniel_leal-olivas-afp

Kite’s leukaemia cell therapy application validated by EMA

June 24, 2021
EMA, Kite, leukemia

Kite has announced that their Type II variation application for a new indication to the approved license for autologous anti-CD19-transduced …

News

FDA accepts Ipsen’s NDA for ultra-rare genetic disorder drug

June 1, 2021
Manufacturing and Production EMA, FDA, FOP, NDA, ipsen

The FDA have accepted Ipsen’s New Drug Application (NDA) for palovarotene, an oral, investigational, selective RARγ agonist for the prevention …

News
takeda_usa_pharmaceuticals_u

Takeda: Dengue vaccine successful in long-term trials & set for global distribution

May 25, 2021
Manufacturing and Production EMA, Vaccine, dengue

Japanese pharma company Takeda has announced long-term safety and efficacy results for its dengue vaccine candidate, TAK-003, and has successfully …

News
vertex-headquarters

Vertex applies to expand indication of cystic fibrosis drug

May 20, 2021
EMA, MHRA, cystic fibrosis

Vertex has announced that the EMA and MHRA have validated the post marketing applications for an expanded indication of Kaftiro …

News

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Novo Nordisk partners with UNICEF to prevent global childhood obesity

September 21, 2023

EC approves Menarini Group’s Orserdu for breast cancer treatment

September 21, 2023

Pharmanovia acquires CNS portfolio from Sanofi

September 20, 2023

Exscientia enters AI drug discovery collaboration with Merck KGaA

September 20, 2023

EC approves Pfizer’s Litfulo for adolescents and adults with alopecia

September 19, 2023