Medscape13m
EMA Expedites Adolescent Chikungunya Vaccine Recommendation
Marketing authorization for the first EU vaccine to protect adolescents against chikungunya has been expedited for its public ...
Medscape15m
EMA Recommends Approval of Capvaxive Pneumococcal Vaccine
The European Medicines Agency (EMA) has recommended granting marketing authorization for the pneumococcal vaccine Capvaxive (pneumococcal polysaccharide conjugate vaccine [21-valent]) intended to ...
Merck's CAPVAXIVE gains CHMP nod for EU authorization
RAHWAY, N.J. - Merck & Co ., Inc. (NYSE:MRK) has received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its pneumococcal ...
AstraZeneca, Daiichi win EU backing for breast cancer drug Dato-DXd
AstraZeneca (AZN) stock in focus as its partner Daiichi Sankyo (DSNKY) wins EU backing for their jointly developed breast ...
IFLScience11d
FDA Authorizes Marketing For Nicotine Pouches For First Time – What Does This Mean?
After reviewing the scientific evidence, the agency has decided 20 ZYN nicotine pouch products can legally be sold in the US.
The American Journal of Managed Care10d
In a First-of-Its-Kind Decision, FDA Will Allow Marketing of Nicotine Pouches
This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free ...
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
Submission supported by positive results from global, Phase 3 4WHIM clinical trial;U.S. regulatory approval in WHIM syndrome granted in ...
FDA makes key decision on Zyn nicotine pouches
In a statement, the FDA said it has authorized the marketing and sale of Philip Morris International’s Zyn nicotine pouches.
For first time, FDA approves marketing of nicotine pouch products
The U.S. Food and Drug Administration on Thursday okayed the marketing of 20 Zyn nicotine pouch products after undertaking an extensive scientific review of them.
EurekAlert!2d
High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD
High-quality evidence for the treatment of very rare diseases: IQWiG is involved in the EU project RealiseD Developing clinical trials to provide good evidence for very rare diseases, so that ...