GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

Shots: The Japanese MHLW has accepted the NDA of bepirovirsen, an antisense oligonucleotide, for the treatment of adults with chronic hepatitis B (CHB) NDA was supported by the P-III (B-Well 1 & B-Well 2) trial results assessing bepirovirsen vs PBO in pts from 29 countries for the treatment of CHB Trials showed statistically significant &…

ByRidhi Rastogi3 days ago

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GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

Shots: The Chinese NMPA has accepted NDA & granted priority review to linerixibat, an IBAT inhibitor, for the treatment of cholestatic pruritus in primary biliary cholangitis (PBC) pts; regulatory review is ongoing in the US, EU, UK & Canada NDA was supported by P-III (GLISTEN) trial assessing linerixibat (40mg) vs PBO to treat PBC pts…

ByRidhi Rastogi4 days ago

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BMS Reports the US FDA’s NDA Acceptance for Iberdomide Combination in R/R Multiple Myeloma

Shots: The US FDA has accepted the NDA of iberdomide + daratumumab & dexamethasone (IberDd) for the treatment of pts with r/r multiple myeloma, with submission to be reviewed under Project Orbis (PDUFA: Aug 17, 2026) NDA was supported by the planned analysis of MRD negativity rates in the P-III (EXCALIBER-RRMM) trial assessing IberDd vs…

ByRidhi RastogiFebruary 18, 2026

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Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Shots: The US FDA has accepted NDA & granted priority review to oveporexton (TAK-861) for the treatment of NT1, with PDUFA goal date in Q3’26 NDA was supported by robust clinical data, incl. global P-III (FirstLight & RadiantLight) trials assessing oveporexton in NT1 pts Oveporexton showed objective and patient-reported improvements in wakefulness, EDS, cataplexy, attention,…

ByRidhi RastogiFebruary 10, 2026

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Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Shots: The US FDA has accepted NDA of zanzalintinib + Tecentriq (atezolizumab) for the treatment of adults with mCRC who have been previously treated with fluoropyrimidine, oxaliplatin & irinotecan-based CT, &, if RAS wild-type, an anti-EGFR therapy (PDUFA: Dec 03, 2026) NDA was based on P-III (STELLAR-303) trial assessing zanzalintinib in combination with atezolizumab (n=451)…

ByRidhi RastogiFebruary 3, 2026

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Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

Shots: The US FDA has received an NDA of lirafugratinib for the 2L treatment of cholangiocarcinoma (CCA) patients with FGFR2 fusion or rearrangement NDA was backed by the P-I/II (ReFocus) trial, which showed 46.5% ORR, 12mos. PFS rate of 49.2% (mPFS: 11.3mos.), 12mos. OS of 74.6% (mOS: 22.8mos.), DCR of 96.5%, & mDoR of 11.8mos.,…

ByRidhi RastogiJanuary 29, 2026

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The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Shots: The US FDA has accepted NDA under priority review of gedatolisib in HR+/ HER2-, PIK3CA wild-type advanced breast cancer, which will be reviewed under RTOR pathway (PDUFA: Jul 17, 2026) NDA was supported by data from the PIK3CA wild-type cohort of the P-III (VIKTORIA-1) study assessing gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2-…

ByRidhi RastogiJanuary 22, 2026

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Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Shots: The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…

ByRidhi RastogiJanuary 13, 2026

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Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Shots: The US FDA has received an NDA of rusfertide (SC) for the treatment of adults with polycythemia vera (PV) NDA was followed by 32wk. primary analysis & 52wk. data from the global P-III (VERIFY) trial (n=293) as well as P-II (REVIVE) study, where VERIFY met its 1EP & all key 2EPs, showing higher response…

ByRidhi RastogiJanuary 6, 2026

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Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

Shots: The US FDA has issued a Complete Response Letter (CRL) to Corcept for the NDA of relacorilant for the treatment of hypertension secondary to hypercortisolism While the US FDA acknowledged that the pivotal P-III (GRACE) study met its 1EP and that data from the GRADIENT study provided supportive evidence, the Agency concluded that additional…

ByDipanshu DixitJanuary 2, 2026

GSK Reports the MHLW’s NDA Acceptance for Bepirovirsen to Treat Chronic Hepatitis B

GSK Reports the NMPA’s NDA Acceptance with Priority Review of Linerixibat for Cholestatic Pruritus

BMS Reports the US FDA’s NDA Acceptance for Iberdomide Combination in R/R Multiple Myeloma

Takeda Receives the US FDA Priority Review for Oveporexton to Treat Narcolepsy Type 1 (NT1)

Exelixis Reports the US FDA’s NDA Acceptance of Zanzalintinib + Tecentriq for Metastatic Colorectal Cancer (mCRC)

Elevar Therapeutics Seeks the US FDA Approval for Lirafugratinib to Treat Cholangiocarcinoma

The US FDA Accepts Celcuity’s Gedatolisib NDA under Priority Review to Treat HR+/HER2- Breast Cancer

Merck KGaA Reports US FDA’s NDA Acceptance of Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)

Takeda and Protagonist Therapeutics Report the US FDA’s NDA Submission for Rusfertide to Treat Polycythemia Vera

Corcept Receives US FDA Complete Response Letter for Relacorilant in Hypercortisolism

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