IFLScience10d
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.
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 ...
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 ...
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 ...
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.
Nasdaq9d
Sanofi Announces Expanded Marketing Authorization For Sarclisa In The EU - Quick Facts
The company noted that, with the expanded marketing authorization, Sarclisa is the first anti-CD38 therapy in combination with VRd in this patient population in the EU. Currently, Sarclisa is ...
Morningstar7d
X4 Pharmaceuticals Announces EMA Validation of Marketing Authorization Application (MAA) for Mavorixafor for the Treatment of WHIM Syndrome
today announced that its Marketing Authorization Application (MAA) for mavorixafor for the treatment of WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis), a rare primary ...