Shots:
The EC has approved Vyjuvek to treat wounds in DEB pts with COL7A1 mutations from birth in all 30 EEA states, with first EU launch set in Germany by mid-2025; MAA under PMDA’s review with decision anticipated in H2'25
Approval was based on comprehensive clinical dataset, incl. P-I/II (GEM-1) & P-III (GEM-3) trial data, showing…
Shots:
The CHMP has recommended Vyjuvek (B-VEC) for treating wounds in DEB pts with COL7A1 mutations from birth. The EC's decision is expected in Q2’25, with launch anticipated under the trade name Vyjuvek in 30 EEA states—Germany in mid-2025 & France in late 2025
Opinion was based on various clinical data, incl. P-I/II (GEM-1)…
Shots:
The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023
In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease
PharmaShots has…

