Submission supported by positive results from global, Phase 3 4WHIM clinical trial;U.S. regulatory approval in WHIM syndrome granted in ...

After reviewing the scientific evidence, the agency has decided 20 ZYN nicotine pouch products can legally be sold in the US.

The FDA has given marketing authorization to Zyn nicotine pouches. That doesn't necessarily mean they're safe to use, especially for young people, and experts say there's little evidence that they ...

The justices leaned toward a narrow ruling that would limit where vape manufacturers can challenge FDA rules for releasing ...

This marketing decision from the FDA covers 2 nicotine strengths, 3 mg and 6 mg, and 10 flavors of the small tobacco-free ...

In a statement, the FDA said it has authorized the marketing and sale of Philip Morris International’s Zyn nicotine pouches.

MeiraGTx's financials show $125 million in cash, but additional funding will be needed within the next 12 months. Click for ...

Sanofi SNY announced that the European Commission (“EC”) has granted marketing authorization to expand the use of its multiple myeloma (MM) drug, Sarclisa (isatuximab). With this nod, Sarclisa is now ...

InflaRx N.V. IFRX shares gained 7.7% on Wednesday following the European Commission's (EC) approval of marketing ...

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 ...