Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Shots: The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025 Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT…

ByRidhi RastogiSeptember 22, 2025

NEWS

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Shots: The CHMP has recommended Enflonsia to prevent RSV lower respiratory tract disease in newborns & infants entering their first RSV season, with potential approval valid in all 30 EEA states Opinion was based on P-IIb/III (CLEVER) study assessing Enflonsia in preterm & full-term infants (≤1yr.), plus P-III (SMART) study of Enflonsia vs palivizumab in high-risk…

ByRidhi RastogiSeptember 22, 2025

NEWS

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

Shots: The CHMP has recommended Nipocalimab as an add-on therapy to treat anti-AChR Ab+ & anti-MuSK Ab+ gMG pts (≥12yrs.) Opinion was based on the P-III (Vivacity-MG3) trial assessing nipocalimab (30mg/kg, IV loading dose then 15mg/kg, Q2W) + SoC vs PBO + SoC in gMG pts (N=199; 153 were Ab +ve), which showed improved MG-ADL score…

ByRidhi RastogiSeptember 22, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)  

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)   This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, COVID-19, M&A and Biosimilars. Check out our full report below:   MAIA Biotechnology Reports P-II (THIO-101) Trial Data of Ateganosine Regimen for Advanced NSCLC Read More: MAIA Biotechnology Akeso Reports First…

ByRidhi RastogiSeptember 19, 2025

NEWS

KalVista Pharmaceuticals Reports EC and Swissmedic Approval of Ekterly (Sebetralstat) for Hereditary Angioedema (HAE)

Shots: The EC and Swissmedic have approved Ekterly to treat acute HAE attacks in pts (age≥12) across EEA states. Launch is expected in Germany in Q4’25 and in Switzerland in H2’26 Ekterly’s approval by the EC and Swissmedic was based on the P-III (KONFIDENT) trial. Published in NEJM (May 2024), results showed significantly faster symptom…

ByDipanshu DixitSeptember 19, 2025

NEWS

The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

Shots: The US FDA has received accelerated approval from the US FDA for Forzinity (elamipretide HCl)] to improve muscle strength in pts with Barth syndrome (Wt.≥30 kg or 66 lbs) Approval was based on efficacy and safety data from the TAZPOWER trial, which showed improved knee muscle strength Forzinity is a mitochondrial cardiolipin binder. It…

ByDipanshu DixitSeptember 19, 2025

NEWS

The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU

Shots: The EC has approved Voranigo for treating patients (age: ≥12yrs.; wt≥ 40kg) with Gr2 astrocytoma or oligodendroglioma with a susceptible IDH1/2 mutation post-surgery, but do not currently require radiotherapy or CT across EEA states Approval was based on the global pivotal P-III (INDIGO) trial, which demonstrated that vorasidenib significantly improved PFS and TTNI vs…

ByDipanshu DixitSeptember 19, 2025

NEWS

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Shots: The FDA has approved Opzelura cream 1.5% for short-term and non-continuous treatment of mild to moderate AD in non-immunocompromised children (aged≥ 2), when other topical therapies are ineffective or unsuitable sNDA approval was based on the P-III (TRuE-AD3) trial which evaluated the safety and efficacy of ruxolitinib in over 300 children receiving 0.75%, 1.5%,…

ByDipanshu DixitSeptember 19, 2025

NEWS

Biogen’s Zurzuvae Receives the EC’s Approval to Treat Severe Postpartum Depression

Shots: The EC has approved Zurzuvae (zuranolone) for the treatment of postpartum depression in adults following MHRA’s approval in Aug 2025 Approval was based on P-III (SKYLARK) trial assessing Zurzuvae (50mg) vs PBO in pts with severe postpartum depression Trial met its 1EP with a significant mean reduction in HAMD-17 total score at Day 15,…

ByRidhi RastogiSeptember 18, 2025

NEWS

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots: The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…

ByRidhi RastogiSeptember 18, 2025

Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

The CHMP Adopts Positive Opinion on Merck’s Enflonsia for RSV Prevention in Infants

Johnson & Johnson Reports the CHMP’s Positive Opinion of Nipocalimab for Generalized Myasthenia Gravis (gMG)

PharmaShots Weekly Snapshots (Sep 15, 2025 – Sep 19, 2025)

KalVista Pharmaceuticals Reports EC and Swissmedic Approval of Ekterly (Sebetralstat) for Hereditary Angioedema (HAE)

The US FDA Grants Accelerated Approval to Stealth BioTherapeutics’ Forzinity for Barth Syndrome

The EC Approves Servier’s Voranigo (vorasidenib) for Grade 2 IDH-Mutant Glioma in the EU

Incyte Reports the US FDA’s sNDA Approval of Opzelura (Ruxolitinib) for Atopic Dermatitis (AD)

Biogen’s Zurzuvae Receives the EC’s Approval to Treat Severe Postpartum Depression

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

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