European Medicines Agency
Fake Ozempic products seized in EU and UK, Novo Nordisk warns
As Novo Nordisk grapples with the challenges posed by illicit sales of semaglutide, authorities in the UK and Europe have ...
EU regulator denies approval for Amylyx’s Albrioza, a potential ALS treatment
While Amylyx’s ALS drug, known as Albrioza in Europe and Relyvrio in the US, has made significant strides in the ...
Sandoz gets CHMP nod for biosimilar of Herceptin, a drug for HER2+ breast and gastric cancer
Sandoz, a leading global player in generic and biosimilar medications, has received a noteworthy endorsement from the Committee for Medicinal ...
PTC Therapeutics’ Translarna at risk of losing EU approval after failing to impress FDA for DMD
PTC Therapeutics is facing a significant setback as it seeks to maintain approval for its Duchenne muscular dystrophy (DMD) therapy, ...
EMA Accepts Filing for Odronextamab to Address Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-Cell Lymphoma
Regeneron Pharmaceuticals achieved a significant milestone with the European Medicines Agency (EMA) accepting the Marketing Authorization Application (MAA) for odronextamab, ...
Sandoz’s Biosimilar Natalizumab Receives Positive CHMP Opinion for Multiple Sclerosis Treatment
Source – Novartis On July 24, 2023 Sandoz announced a significant milestone. The Committee for Medicinal Products for Human Use ...
GLP-1 medications from Novo Nordisk are being examined in Europe following reports suggest potential suicide risks
Following reports of two cases of suicidal thoughts and one case of self-harm among users in Iceland, the European Medicines ...
Moderna Submits Global Regulatory Applications for its RSV Vaccine, mRNA-1345
Source – Moderna On July 5, 2023 Moderna, a biotech company at the forefront of mRNA vaccines, shared an update ...
For its updated Covid-19 vaccine, Moderna submits a regulatory application to the European Medicines Agency
Source – Moderna On July 3, 2023 Moderna announced the submission of a regulatory application to the European Medicines Agency ...
Regulatory Update: Amylyx’s ALS drug faces rejection by the European Medicines Agency (EMA)
Source – Amylyx Pharmaceuticals On June 23, 2023, the European Medicines Agency (EMA) has formally issued a negative opinion regarding ...
Boehringer Ingelheim’s Zantac arbitration is won by Sanofi
Source – Sanofi On 20 June 2023 in Paris, Sanofi reports that the International Chamber of Commerce tribunal has rejected ...
In Germany, a COVID-19 vaccine damage claim will be defended by BioNTech
Source- BioNTech The COVID-19 vaccine partner of Pfizer, BioNTech, is going to court in its native Germany to defend itself ...
