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  • European Medicines...

Tag: european medicines agency

You Searched For "European Medicines Agency"
Orchid Pharmas new antibiotic Exblifeb gets European Medicines Agency approval

Orchid Pharma's new antibiotic 'Exblifeb' gets European Medicines Agency approval

Kajal Rajput30 Jan 2024 2:15 PM IST
New Delhi: Orchid Pharma on Tuesday said it has received approval from the European Medicines Agency for marketing its antibiotic 'Exblifeb'. The...
Garadacimab, XIIa inhibitor, receives FDA and EMA Filing acceptance for hereditary angioedema

Garadacimab, XIIa inhibitor, receives FDA and EMA Filing acceptance for hereditary angioedema

Medha Baranwal22 Dec 2023 5:45 PM IST
USA: Garadacimab, a first-in-class factor XIIa inhibitor, has received the Food and Drug Administration (FDA) and European Medicines Agency (EMA)...
No casual link found between GLP-1 drugs like Novo Nordisk Ozempic, thyroid cancer: EMA

No casual link found between GLP-1 drugs like Novo Nordisk Ozempic, thyroid cancer: EMA

Ruchika Sharma29 Oct 2023 12:30 PM IST
The European Medicines Agency (EMA) has said its safety panel did not find a causal link between popular GLP-1 drugs such as Novo...
Europe to face shortage of Eli Lilly diabetes drug Trulicity through September

Europe to face shortage of Eli Lilly diabetes drug Trulicity through September

Ruchika Sharma30 Aug 2023 11:30 AM IST
Europe: Europe will continue to face a shortage of Eli Lilly & Co's blockbuster diabetes drug Trulicity through September, the European Medicines...
CDSCO panel recommends market authorization for Covovax jab as heterologous booster dose

CDSCO panel recommends market authorization for Covovax jab as heterologous booster dose

MD Bureau13 Jan 2023 3:21 PM IST
New Delhi: An expert panel of the central drugs regulatory authority is likely to take a decision on Wednesday on granting market authorisation to...
GSK Depemokimab applications accepted for review in China, Japan for asthma with type 2 inflammation, CRSwNP

EMA validates marketing authorization application for blood cancer oral treatment Momelotinib: GSK

Ruchika Sharma5 Dec 2022 10:30 AM IST
Myelofibrosis is a rare blood cancer that results from dysregulated JAK-signal transducer and activator of transcription protein signalling and is...
Strides Pharma Secures NCLT Approval for OneSource, India’s First Specialty Pharma CDMO

Strides Pharma Science biologics arm gets EMA nod for osteoporosis drug Kauliv

Ruchika Sharma14 Nov 2022 12:30 PM IST
Kauliv is a biosimilar to Forsteo (innovator product), indicated for both men and postmenopausal women with osteoporosis who are at high risk for...
ViiV Healthcare Cabotegravir long-acting injectable for HIV prevention gets EMA validation

ViiV Healthcare Cabotegravir long-acting injectable for HIV prevention gets EMA validation

Ruchika Sharma30 Oct 2022 11:45 AM IST
Cabotegravir long-acting for PrEP is an integrase strand transfer inhibitor (INSTI).
Takeda gets positive CHMP opinion recommending nod of Dengue Vaccine in EU, Dengue-endemic countries

Takeda gets positive CHMP opinion recommending nod of Dengue Vaccine in EU, Dengue-endemic countries

Ruchika Sharma16 Oct 2022 12:00 PM IST
Japan: Takeda has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA)...
Pfizer, BioNTech complete submission to EMA for Omicron BA.4/BA.5-Adapted Bivalent vaccine booster in children aged 5 Through 11 years

Pfizer, BioNTech complete submission to EMA for Omicron BA.4/BA.5-Adapted Bivalent vaccine booster in children aged 5 Through 11 years

Ruchika Sharma2 Oct 2022 3:45 PM IST
COMIRNATY, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.
Sanofi gets EMA Committee recommendation for approval of Enjaymo for hemolytic anemia in adult patients with cold agglutinin disease

Sanofi gets EMA Committee recommendation for approval of Enjaymo for hemolytic anemia in adult patients with cold agglutinin disease

Ruchika Sharma18 Sept 2022 10:45 AM IST
Paris: Sanofi has recently announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted...
EMA on alert over new variants of COVID: Official

EMA on alert over new variants of COVID: Official

Ruchika Sharma5 Sept 2022 11:30 AM IST
On Thursday, the EMA ’s human medicines committee (CHMP) recommended the use of two vaccines adapted against the Omicron variant of Covid-19 from...
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