Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

Shots: Corcept has reported P-III (ROSELLA) trial data assessing relacorilant (PO, GR antagonist) + nab-paclitaxel vs nab-paclitaxel in 381 pts with PROC Trial met its 1EP of OS, showing a 35% reduction in death risk (mOS: 16 vs 11.9mos.), & previously met its PFS endpoint with a 30% reduction in progression risk, as presented at…

ByRidhi RastogiJanuary 23, 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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SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

Shots: The US FDA has granted clearance to ION-C Facet Fixation System, part of SurGenTec’s posterior cervical platform, for the treatment of cervical pseudoarthrosis Clearance was supported by IRB-approved long-term study data showing bridging bone across facet joints with no reported AEs, implant migration, or revision surgeries, & postoperative imaging confirming preserved cervical alignment &…

ByRidhi RastogiJanuary 21, 2026

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The US FDA Accepts Levicept’s LEVI-04 IND Application for Osteoarthritis

Shots: The US FDA has accepted IND application for LEVI-04 for the treatment of osteoarthritis Levicept has completed the P-II trial of LEVI-04 in 518 patients with pain & disability due to knee OA, with ACR Convergence data showing the 1EP was met & demonstrated significant analgesia & symptom control across all doses Further analyses…

ByRidhi RastogiJanuary 20, 2026

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iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Shots: The US FDA has granted RMAT designation to NouvNeu001 for the treatment of Parkinson's disease The P-I data showed marked improvements in MDS-UPDRS Part III motor scores, as low-dose pts achieved 30.6 (OFF; 52.82% improvement) & 12.9 (ON; 54.67% improvement) points at 12mos. & high-dose pts 23.3 (OFF) & 9.67 (ON) at 9mos., with…

ByRidhi RastogiJanuary 20, 2026

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Boehringer Ingelheim Reports the FDA Approval of Vetmedin to Delay Onset of Congestive Heart Failure in Dogs

Shots: The US FDA has granted full approval to Vetmedin chewable tablets (pimobendan) & Vetmedin oral solution for the delay of onset of CHF in dogs with Stage B2 preclinical myxomatous mitral valve disease (MMVD) Approval was based on the 2 multi-site studies, with the EPIC trial showing Vetmedin delayed CHF onset or cardiac-related death…

ByRidhi RastogiJanuary 20, 2026

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Johnson & Johnson Highlights Clinical Data on Caplyta (Lumateperone) for Major Depressive Disorder (MDD) at ACNP 2026

Shots: Data from the OLE 503 study of Caplyta & pooled results from P-III (Studies 501 & 502) trials assessing Caplyta vs PBO, both in combination with an antidepressant, in adults with MDD presented at ANCP’26 Pooled data showed higher remission (MADRS ≤10) with treatment at 6wks. (25.5% vs 13.6%), with complete remission (MADRS ≤5) in 10.6%…

ByRidhi RastogiJanuary 19, 2026

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Emergent BioSolutions Receives US FDA Approval of sNDA for NARCAN Nasal Spray with New Carrying Case to Reverse Opioid Overdoses

Shots: The US FDA has approved Emergent BioSolutions’ supplemental NDA (sNDA) for over-the-counter (OTC) NARCAN Nasal Spray to be packaged in a new, compact carrying case designed to improve portability and everyday preparedness The new carrying case includes two blister-packed doses with a Quick Start Guide and is intended to increase accessibility, discretion, and likelihood…

ByDipanshu DixitJanuary 15, 2026

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Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Shots: The US FDA has granted Breakthrough Therapy Designation (BTD) to Ipsen’s investigational therapy IPN60340 (ICT01) in combination with venetoclax and azacitidine for the treatment of 1L unfit acute myeloid leukemia (AML) The designation was supported by data from the P-I/II (EVICTION) study (n=57), where IPN60340 + Ven-Aza showed encouraging response rates, including a near…

ByPrince GiriJanuary 14, 2026

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Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

Shots: The US FDA has approved Zycubo (copper histidinate) for the treatment of pediatric patients with Menkes disease Approval was supported by clinical data showing improved OS with early Zycubo treatment vs an untreated external control, reflecting ~80% reduction in the risk of death & a mOS of 177.1 vs 17.6mos. Zycubo is a bioavailable…

ByRidhi RastogiJanuary 14, 2026

Corcept Therapeutics Reports P-III (ROSELLA) Trial Data on Relacorilant for Platinum-Resistant Ovarian Cancer (PROC)

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

SurGenTec Receives the US FDA Clearance for ION-C Facet Fixation System

The US FDA Accepts Levicept’s LEVI-04 IND Application for Osteoarthritis

iRegene Therapeutics’ NouvNeu001 Receives the US FDA RMAT Designation in Parkinson’s Disease

Boehringer Ingelheim Reports the FDA Approval of Vetmedin to Delay Onset of Congestive Heart Failure in Dogs

Johnson & Johnson Highlights Clinical Data on Caplyta (Lumateperone) for Major Depressive Disorder (MDD) at ACNP 2026

Emergent BioSolutions Receives US FDA Approval of sNDA for NARCAN Nasal Spray with New Carrying Case to Reverse Opioid Overdoses

Ipsen Receives US FDA Breakthrough Therapy Designation for IPN60340 in Unfit Acute Myeloid Leukemia

Sentynl Therapeutics Reports US FDA Approval of Zycubo to Treat Pediatric Menkes Disease

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