Henlius and Intas receive Positive CHMP Opinion for HETRONIFLY® (approved as HANSIZHUANG in China) in European markets as First-Line Treatment for adult pati…
HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...
DPA International on MSN1d
EU extends authorization of the mpox vaccine to adolescents
The European Commission on Friday extended the authorization of the Imvanex mpox vaccine to teenagers aged 12 to 17.
Maintaining Buy Rating on Apellis Pharmaceuticals Amid European Setback and US Market Focus
Bank of America Securities analyst Tazeen Ahmad has maintained their bullish stance on APLS stock, giving a Buy rating yesterday. Tazeen Ahmad ...
The Pharma Letter1d
Latest batch of EMA’s human medicines committee recommendations
Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting ...
Pharmabiz1d
EMA’s human medicines committee elects Bruno Sepodes as new chair
EMA’s human medicines committee elects Bruno Sepodes as new chair: Amsterdam, The Netherlands Friday, September 20, 2024, ...
Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and ...
Merck Gets European Panel Backing for Keytruda in Two Gynecologic Cancers
Merck & Co. said a European Medicines Agency panel recommended expanded approval of the drugmaker's blockbuster cancer treatment Keytruda in two types of gynecologic cancers.
PipelineReview.com1d
Wegovy® recommended by the European regulatory authorities for label update to reflect reduced heart failure symptoms and improved physical function
BAGSVAERD, Denmark I 19, 2024 I Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human ...
PharmiWeb17d
Prilenia’s Pridopidine for Huntington’s Disease Accepted for European Marketing Authorisation Review
Pridopidine’s Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) is the first submission for approval for an investigational new treatment for adults with Huntington’s ...
European shares slip but set for weekly gains; Mercedes drops
By Shubham Batra (Reuters) -European shares slipped on Friday after a rally in the previous session spurred by the U.S.
BioNTech SE: Pfizer and BioNTech Receive Positive CHMP Opinion for Omicron KP.2-adapted COVID-19 Vaccine in the European Union
Upon authorization by the European Commission, the Omicron KP.2-adapted COVID-19 vaccine will be available for individuals 6 months of age and older Data demonstrate that the Omicron KP.2-adapted ...
Medscape1d
Two New Drugs Approved for Age-Related Macular Degeneration
The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...