Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…
Shots: The EMA’s CHMP has granted positive opinions and approvals to 3 Biologics and 10 new chemical entities in July 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Roche’s Itovebi Secures the EC’s Approval for PIK3CA-mutated Breast Cancer PharmaShots has compiled a list of 13 drugs…
Shots: AbbVie adds an eighth indication to Rinvoq’s label with the European Commission’s approval for treating adult patients with giant cell arteritis (GCA) Sofie Berg, Therapeutic Area Head of International Immunology at AbbVie, in a conversation with PharmaShots, shares insights from the SELECT-GCA trial evaluating Rinvoq in GCA, highlighting both primary and secondary endpoints Rinvoq…
Shots:EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada
Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…
Shots: The EC has approved to 5 Biologics and 3 New Chemical Entities in August 2024, leading to treatments for patients and advances in the healthcare industry The major highlighted drugs were Johnson & Johnson’s Balversa to treat Metastatic Urothelial Carcinoma (mUC) and Takeda’s Adzynma for Congenital Thrombotic Thrombocytopenic Purpura (cTTP) PharmaShots has compiled a list…
Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients The major highlights were NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal…
Shots : Followed by the CHMP’s positive opinion in Nov 2023 for Crohn’s disease, psoriasis and psoriatic arthritis, the EC has approved Uzpruvo across the EU and Iceland, Liechtenstein, and Norway The approval was based on the analytical & clinical results, data from the study (AVT04-GL-301) comparing the safety and efficacy of AVT04 vs Stelara…

