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

NEWS

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Shots: Roche reported positive topline results from the P-II (CT388-103) study evaluating CT-388, an investigational dual GLP-1/GIP receptor agonist, for the treatment of obesity Once-weekly CT-388 (SC) achieved a statistically significant PBO-adjusted weight loss of 22.5% (p<0.001; efficacy estimand) at 48 wks. at the highest dose (24 mg), with no weight-loss plateau observed; 54% of…

ByPrince GiriJanuary 28, 2026

NEWS

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Shots: The US FDA has cleared Novaliq’s IND application for NOV05, enabling initiation of the EYETAC P-II clinical study in pts with non-infectious anterior uveitis (NIAU) The EYETAC P-II study will be conducted in the US and is expected to begin in Q1’26, evaluating the safety, tolerability, and dose-dependent anti-inflammatory effects of NOV05 NOV05 is…

ByPrince GiriJanuary 27, 2026

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Ascletis Reports First Participants Dosing in US P-II Study of ASC30 for Type 2 Diabetes

Shots: Ascletis Pharma reported that the first participants have been dosed in a US 13-week P-II study of ASC30, an oral small-molecule GLP-1 receptor agonist, for the treatment of type 2 diabetes mellitus, with topline data expected in Q3’26 The study will enroll ~100 pts and evaluate ASC30’s effects on HbA1c as a 1EP, and…

ByPrince GiriJanuary 27, 2026

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Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Shots: Crinetics has dosed the first patient with atumelnant in the P-II/III (BALANCE-CAH) trial for the treatment of classic congenital adrenal hyperplasia (CAH) in children & adolescents The study will evaluate atumelnant across 3 phases: a P-II semi-sequential dose-ranging Part A, followed by a P-III PBO-controlled Part B, & an OLE portion in Part C…

ByRidhi RastogiJanuary 23, 2026

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Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Shots: Mabwell has dosed the first patient with 7MW4911 in a P- I/II study in the US for the treatment of advanced colorectal cancer & other advanced GI tumors Preclinical studies showed that 7MW4911 delivered potent antitumor activity across CDX/PDX GI tumor models & outperformed MMAE/DXd-based ADCs in multidrug-resistant settings. It also reversed tumor progression after…

ByRidhi RastogiJanuary 23, 2026

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Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

Shots: Ocugen has reported preliminary 12mos. data from its P-II (ArMaDa) trial (n=51) of OCU410 (AAV5-RORA) in GA secondary to dry AMD, with ~50% of pts evaluated to date Trial showed a 46% reduction in GA lesion growth vs control (medium + high dose), with the medium dose achieving a 54% reduction; 50% pts achieved…

ByRidhi RastogiJanuary 16, 2026

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J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Shots: J&J has reported longer follow-up results from Cohorts D & E of the P-Ib/II (OrigAMI-1) trial assessing Rybrevant (amivantamab-vmjw; IV) ± FOLFOX/FOLFIRI in pts with RAS/BRAF wild-type mCRC At mFU of 16mos., Rybrevant + FOLFOX (n=20) or FOLFIRI (n=23) achieved a cORR of 51%, with early responses & median time to first response of 8.3wks.,…

ByRidhi RastogiJanuary 12, 2026

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Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Shots: The EC has approved Sanofi's Teizeild (Tzield outside the EU) 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 Approval was based on the P-II (TN-10) trial assessing Teizeild (QD, n=44) vs PBO (n=32)…

ByRidhi RastogiJanuary 12, 2026

NEWS

Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

Shots: Madrigal has entered into an exclusive global license agreement with Pfizer for ervogastat (PF-06865571; PO) to treat metabolic dysfunction-associated steatohepatitis (MASH) As per the deal, Madrigal will receive an exclusive global license to develop, manufacture & commercialize ervogastat & 2 additional early-stage MASH assets, paying Pfizer $50M upfront with further milestone payments & net…

ByRidhi RastogiJanuary 12, 2026

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

Roche Reports Positive P-II Results of Dual GLP-1/GIP Agonist CT-388 in Obesity

Novaliq Receives US FDA IND Clearance to Advance NOV05 into P-II Trial for Non-infectious Anterior Uveitis

Ascletis Reports First Participants Dosing in US P-II Study of ASC30 for Type 2 Diabetes

Crinetics Pharmaceuticals Doses First Patient in P-II/III (BALANCE-CAH) Trial of Atumelnant for Pediatric Congenital Adrenal Hyperplasia

Mabwell Doses First US Patient in P-I/II Trial of 7MW4911 for Gastrointestinal (GI) Cancers

Ocugen Reports Positive Preliminary P-II (ArMaDa) Data of OCU410 in Geographic Atrophy (GA) Secondary to Dry AMD

J&J Presents the P-Ib/II (OrigAMI-1) Trial Data on Rybrevant for Metastatic Colorectal Cancer at ASCO GI 2026

Sanofi’s Teizeild (Teplizumab) Receives the EC Approval to Delay Progression of Type 1 Diabetes

Madrigal Pharmaceuticals Broadens MASH Pipeline with Pfizer’s Ervogastat Deal

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