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 Rastogi3 days ago

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 Rastogi4 days ago

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

LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE)

Shots: China’s NMPA has accepted NDA of Anzupgo cream (delgocitinib) for treating mod. to sev. chronic hand eczema (CHE) in adults, who had an inadequate response or are unamenable to topical corticosteroids; decision expected in 2027 NDA was based on P-III (DELTA China) trial assessing Anzupgo (BID) vs vehicle in 362 Chinese pts with mod. to sev.…

ByRidhi RastogiOctober 17, 2025

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HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Shots: HUTCHMED has reported the P-II/III (FRUSICA-2) trial data assessing fruquintinib + sintilimab vs axitinib/everolimus as 2L treatment in 234 pts with locally advanced or metastatic RCC As of Feb 17, 2025 (mFU of 16.6mos.), regimen showed a mPFS of 22.2 vs 6.9mos., ORR of 60.5% vs 24.3%, & mDoR 23.7 vs 11.3mos., with benefits observed…

ByRidhi RastogiOctober 13, 2025

NEWS

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

Shots: The EMA has received MAA for TransCon CNP (navepegritide) for the treatment of children with achondroplasia; NDA is under the US FDA’s priority review (PDUFA: Nov 30, 2025) MAA is supported by 3 trials assessing TransCon CNP vs PBO & up to 3yrs. of OLE data, incl. ApproaCH trial results in children with achondroplasia,…

ByRidhi RastogiOctober 9, 2025

NEWS

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

Shots: The US FDA has received an NDA for tavapadon (QD, PO) for Parkinson’s disease (PD), supported by P-III (TEMPO-1 & 2) trials in early PD & P-III (TEMPO-3) evaluating adjunctive use with levodopa in pts with motor fluctuations, plus interim data from P-III (TEMPO-4) open label study TEMPO-1 (n=529) & TEMPO-2 (n=304) evaluated fixed…

ByRidhi RastogiSeptember 29, 2025

NEWS

Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Shots: Japan’s PMDA has accepted the NDA of nadofaragene firadenovec (intravesically; Q3W) for the treatment of Bacillus Calmette-Guérin (BCG)-unresponsive HR-NMIBC with CIS ± papillary tumors (Ta/T1) NDA was backed by P-III study evaluating nadofaragene in 157 pts, where 5yr. follow-up data showed OS rate of 80% & a 49% cystectomy-free survival in adults with CIS…

ByRidhi RastogiSeptember 12, 2025

NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…

ByRidhi RastogiSeptember 11, 2025

NEWS

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

Shots: The US FDA has accepted NDA of ensitrelvir fumaric acid for the prevention of COVID-19 following exposure to an infected individual (PDUFA: Jun 16, 2026); regulatory review is ongoing in Taiwan, Japan (for both PEP & paediatric pts), & the EU NDA was supported by global P-III (SCORPIO-PEP) trial assessing ensitrelvir vs PBO as post-exposure…

ByRidhi RastogiSeptember 3, 2025

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)

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

LEO Pharma Reports the NMPA’s NDA Acceptance for Anzupgo (Delgocitinib) to Treat Chronic Hand Eczema (CHE)

HUTCHMED Reports the P-II/III (FRUSICA-2) Trial Data of Fruquintinib + Sintilimab for Renal Cell Carcinoma (RCC)

Ascendis Pharma Reports the EMA’s MAA Submission for TransCon CNP to Treat Achondroplasia in Children

AbbVie Reports the US FDA’s NDA submission of Tavapadon to Treat Parkinson’s Disease

Ferring Reports the PMDA’s NDA Acceptance of Nadofaragene Firadenovec to Treat BCG-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer (HR-NMIBC)

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shionogi Reports the US FDA’s Acceptance of Ensitrelvir Post-Exposure COVID-19 Prevention

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