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

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early Breast Cancer

Shots: Genentech has reported P-III (lidERA Breast Cancer) trial assessing giredestrant (QD) vs SoC endocrine therapy in pts (n=~4,100) with medium or high-risk stage I-III ER+, HER2- breast cancer Trial met its 1EP of improved invasive disease-free survival & showed a favorable OS trend; OS data remains immature. Results to be presented in future meetings…

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

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

ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Shots: The US FDA has accepted an NDA of 177Lu-edotreotide (ITM-11) for the treatment of GEP-NETs, with a PDUFA goal date of Aug 28, 2026 NDA was supported by the P-III (COMPETE) trial assessing ITM-11 vs everolimus (N=309) as a 1/2L treatment of inoperable, progressive, SSTR+ Grade 1 or 2 GEP-NETs, which met its 1EP of…

ByRidhi RastogiNovember 13, 2025

NEWS

Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria

Shots: The P-III (KALUMA) trial assessed KLU156 (ganaplacide/lumefantrine, or GanLum) vs Coartem for treating acute, uncomplicated malaria due to Plasmodium falciparum in 1,668 adults & children (≥10kg) across 12 African countries Trial showed non-inferiority to the SoC (1EP), achieving a PCR-corrected adequate clinical & parasitological response (APCR) of 97.4% vs 94% (post hoc per-protocol cure…

ByRidhi RastogiNovember 13, 2025

NEWS

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Shots: EirGenix has partnered with Sandoz to commercialize EG1206A, a biosimilar to Roche’s Perjeta (Pertuzumab), globally excl. Taiwan, Mainland China, Macau, South Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines, & Japan As per the deal, EirGenix will handle product development, manufacturing, & supply, receiving ~$152M in upfront & milestone payments, profit share post-launch…

ByRidhi RastogiNovember 12, 2025

NEWS

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Shots: Cogent Biosciences has reported the P-III (PEAK) trial data assessing bezuclastinib + sunitinib vs sunitinib monotx. in pts with imatinib-resistant or intolerant GIST; the US FDA’s NDA filing is planned for H1’26 As of Sep 30, 2025, trial met its 1EP of improved PFS (mPFS: 16.5 vs 9.2mos.) & showed ORR of 46% vs…

ByRidhi RastogiNovember 11, 2025

NEWS

Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

Shots: Genentech has reported the P-III trials results, incl. FENhance 2 study assessing fenebrutinib (PO) vs teriflunomide in 1,497 adults with RMS for ~96wks. Trial met its 1EP of reduced annualized relapse rate over ~96wks. with favorable liver safety; additional safety data will be further evaluated; data to be presented in future meeting, along with…

ByRidhi RastogiNovember 10, 2025

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

Genentech (Roche) Reports Interim P-III (lidERA Breast Cancer) Trial Data on Giredestrant for Early 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)

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

ITM Reports the US FDA’s NDA Acceptance for ¹⁷⁷Lu-edotreotide to Treat Gastroenteropancreatic Neuroendocrine Tumors (GEP-NETs)

Novartis Reports P-III (KALUMA) Trial Data of KLU156 for Uncomplicated Malaria

EirGenix Enters ~$152M Licensing Deal with Sandoz to Commercialize EG1206A (Biosimilar, Perjeta)

Cogent Biosciences Reports P-III (PEAK) Trial Data on Bezuclastinib Combination for Gastrointestinal Stromal Tumors (GIST)

Genentech (Roche) Reveals P-III Trials Findings on Fenebrutinib in Relapsing and Primary Progressive Multiple Sclerosis

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