Month: June 2024

Rhythm Pharmaceuticals Receives Positive CHMP Opinion for ▼IMCIVREE® (setmelanotide) for the Treatment of Obesity and Control of Hunger in Patients between 2 and 6 years old with Bardet Biedl Syndrome or POMC, PCSK1, or LEPR Deficiency

Soleno Therapeutics Announces Submission of New Drug Application to the U.S. FDA for DCCR (Diazoxide Choline) Extended-Release Tablets for the Treatment of Prader-Willi Syndrome

REDWOOD CITY, Calif., June 28, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno”) (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing...

CHMP adopts positive opinion for BALVERSA® (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations

Pending approval, erdafitinib would become the first therapy targeting FGFR3 alterations in patients with metastatic urothelial carcinoma, one of Europe’s...

Odronextamab Recommended for EU Approval by the CHMP to Treat Relapsed/Refractory Follicular Lymphoma and Diffuse Large B-cell Lymphoma

Recommendation based on data from the Phase 1 and pivotal Phase 2 trials demonstrating robust and durable response rates in...

ARS Pharmaceuticals Announces EURneffy (adrenaline nasal spray) Recommended for Approval by CHMP for Emergency Treatment of Allergic Reactions (anaphylaxis)

EURneffy positioned to be the first and only needle-free adrenaline option authorized for emergency treatment of allergic reactions (anaphylaxis) in...

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