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NEWS

BeOne Medicines’ Tevimbra Receives the EC Approval for Nasopharyngeal Carcinoma

Shots: The EC has approved Tevimbra (tislelizumab) + gemcitabine & cisplatin for 1L treatment of adults with metastatic or recurrent nasopharyngeal carcinoma (NPC), not amenable to curative surgery or radiotherapy Approval was based on P-III (RATIONALE-309) trial assessing Tevimbra + gemcitabine & cisplatin vs PBO + gemcitabine & cisplatin in 263 treatment-naïve NPC pts Trial…
July 10, 2025

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VIEWPOINTS

Unlocking Approval: Sofie Berg from AbbVie in a Riveting Conversation with PharmaShots 

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…
July 9, 2025

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Vertex Pharmaceuticals
NEWS

Vertex Pharmaceuticals’ Alyftrek Receives the EC’s Approval to Treat Cystic Fibrosis

Shots:    The EC has approved Alyftrek (deutivacaftor/tezacaftor/vanzacaftor) to treat pts (≥6yrs.) with cystic fibrosis (CF), having ≥1 non-class I mutation in the CFTR gene; regulatory review is ongoing in Canada, Switzerland, Australia, & New Zealand In 2 H2H trials, Alyftrek + ivacaftor matched Kaftrio (ivacaftor/tezacaftor/elexacaftor) on ppFEV1 & showed superiority in reducing sweat chloride…
July 2, 2025

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Novartis
NEWS

Novartis Reports the Health Canada’s Approval of Kisqali (Ribociclib) for the Treatment of HR+/HER2- Early Breast Cancer

Shots: Health Canada has approved Kisqali (ribociclib) + an aromatase inhibitor (AI) for adj. treatment of adults with HR+/HER2-, stage II-III early breast cancer (EBC) at high risk of recurrence Approval was supported by global P-III (NATALEE) study assessing Kisqali + AI vs AI alone as an adj. treatment of pts (n=5101) with stage II & III…
June 19, 2025

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Gilead
NEWS

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots: FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & Peru Approval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…
June 19, 2025

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Merck new
NEWS

Merck Receives the US FDA’s Approval for Perioperative Keytruda for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has approved neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy (RT) ± cisplatin & then as a single agent to treat operable LA-HNSCC based on P-III (KEYNOTE-689) trial Trial assessed neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by adj. Keytruda (15 cycles) + SoC RT ± cisplatin vs…
June 16, 2025

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FDA Drug Approvals May 2025
INSIGHTS+

The US FDA New Drug Approvals in May 2025

Shots:      PharmaShots has compiled a list of US FDA-approved drugs in the month of May 2025       The US FDA has approved a total of 3 new drugs, including 2 new molecular entities and 1 Biologic leading to the treatment of patients and advances in the healthcare industry        The major highlighted drug was AbbVie’s Emrelis securing…
June 10, 2025

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