Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

Shots: The US FDA has approved Epkinly (epcoritamab-bysp) + rituximab & lenalidomide (R2) for the treatment of adults with r/r follicular lymphoma (FL) & converted accelerated approval of Epkinly monotx. to full approval for r/r FL following ≥2L of systemic therapy Approval was based on P-III (EPCORE FL-1) trial assessing Epkinly + R2 (n=243)vs R2 alone(n=245)in…

ByRidhi RastogiNovember 19, 2025

NEWS

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Shots: The US FDA has received an NDA of gedatolisib under the RTOR program for the treatment of HR+, HER2-, advanced breast cancer NDA was supported by data from PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs fulvestrant in HR+/HER2- advanced breast cancer pts Trial showed that gedatolisib…

ByRidhi RastogiNovember 18, 2025

NEWS

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

Shots: The CHMP has recommended Minjuvi (tafasitamab) + rituximab & lenalidomide for the treatment of adult pts with r/r FL (Grade 1-3a) who received ≥1L of systemic therapy Opinion was based on the P-III (inMIND) trial (N=654) assessing Minjuvi combination vs PBO + rituximab & lenalidomide in r/r FL (n=548) & r/r nodal, splenic or…

ByRidhi RastogiNovember 17, 2025

NEWS

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: The CHMP has recommended Dawnzera for the routine prevention of HAE attacks in pts (≥12yrs.) following the US FDA approval in Aug 2025; EC’s decision is expected in Q1’26 Opinion was based on P-III (OASIS-HAE) trial & OASISplus study, showing improvements across multiple domains, incl. sustained reduction in mean monthly HAE attack rate even when Dawnzera…

ByRidhi RastogiNovember 17, 2025

NEWS

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

Shots: The CHMP has recommended Teizeild to delay the onset of stage 3 type 1 diabetes (T1D) in adult & pediatric pts (≥8yrs.) with stage 2 T1D; regulatory review is ongoing in the other regions Opinion was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32) for 14 days in 76…

ByRidhi RastogiNovember 17, 2025

WEEKLY SNAPSHOT

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)    

This week, PharmaShots’ news was all about the updates on Clinical Trials, Regulatory, Pharma, MedTech, M&A, Animal Health, and Biosimilars. Check out our full report below:    Ionis Highlights P-III (CORE & CORE2) Trials Results of Olezarsen for Severe Hypertriglyceridemia (sHTG) at AHA 2025 Read More: Ionis AstraZeneca Reports P-III (NATRON) Trial Data on Fasenra (Benralizumab) to Treat Hypereosinophilic Syndrome (HES) …

ByRidhi RastogiNovember 14, 2025

NEWS

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Shots: The Japanese MHLW has accepted an NDA of Vyepti for the treatment of pts living with migraine, who are eligible for preventive therapy; regulatory review is also ongoing in China & South Korea The NDA was supported by extensive clinical data, incl. the P-III (SUNRISE) trial of Vyepti (100 or 300mg, IV) vs PBO…

ByRidhi RastogiNovember 14, 2025

NEWS

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Shots: The US FDA has accepted the resubmitted BLA of ONS-5010 (bevacizumab-vikg) for the treatment of wAMD, considering a Class 1 review & granting a PDUFA goal date Dec 31, 2025; if approved, it will be branded Lytenava ONS-5010 (intravitreal) is an ophthalmic bevacizumab formulation that binds all VEGF isoforms to block VEGF interaction with…

ByRidhi RastogiNovember 14, 2025

NEWS

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Shots: The US FDA has granted full approval to Komzifti (QD, PO) to treat adults with r/r AML with NPM1 mutation who have no satisfactory alternative treatment options before the PDUFA date of Nov 30, 2025 Approval was backed by P-I/II (KOMET-001) trial in 112 r/r NPM1-mutant AML pts, showing 21.4% CR + CRh with a median…

ByRidhi RastogiNovember 14, 2025

NEWS

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

Shots: The UK’s MHRA has approved Leqembi (IV, Q4W) as a maintenance therapy for early Alzheimer’s pts after completing 18mos. of Q2W Leqembi treatment Leqembi is approved in 51 countries for early AD & under review in 9, while the Q4W maintenance is approved in the UK, China, the US, & others, with 4 applications…

ByRidhi RastogiNovember 14, 2025

Genmab and AbbVie Report the US FDA Approval of Epkinly to Treat R/R Follicular Lymphoma

The US FDA Receives Celcuity’s NDA for Gedatolisib to Treat Advanced Breast Cancer

Incyte’s Minjuvi Combination Gains the CHMP’s Positive Opinion for R/R Follicular Lymphoma (FL)

The CHMP Recommends Ionis and Otsuka’s Dawnzera (Donidalorsen) as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Sanofi’s Teizeild (Teplizumab) Receives the CHMP’s Positive Opinion to Delay Progression of Type 1 Diabetes

PharmaShots Weekly Snapshots (Nov 10, 2025 – Nov 14, 2025)

Lundbeck Reports the MHLW’s NDA Acceptance of Vyepti (Eptinezumab) for the Preventive Treatment of Migraine

Outlook Therapeutics Reports the US FDA’s BLA Acceptance of ONS-5010 to Treat Wet Age-Related Macular Degeneration (wAMD)

Kura Oncology and Kyowa Kirin Report the US FDA’s Approval Komzifti (Ziftomenib) for NPM1-Mutated Acute Myeloid Leukemia (AML)

Eisai and BioArctic Report the MHRA Approval of Leqembi (Lecanemab) as a Maintenance Therapy to Treat Early Alzheimer’s Disease

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