NEWS

Gedeon Richter Receives the CHMP Positive Opinion for Fylrevy for Hormone Replacement Therapy (HRT)

Shots: The CHMP has recommended Fylrevy (estetrol/Donesta) as HRT for oestrogen deficiency symptoms in postmenopausal women, both non-hysterectomised (14.2 mg and 18.9 mg) and hysterectomized (18.9 mg); the decision will be anticipated across EEA markets Fylrevy is an oral estetrol-based oestrogen therapy designed to treat a broad range of oestrogen deficiency symptoms, including VMS, in postmenopausal women Preclinical and clinical data…

January 29, 2026

nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Shots: nChroma Bio has dosed the first patient with CRMA-1001, an epigenetic silencer, in a P-I/II trial for the treatment of hepatitis B virus (HBV) infection The open-label study is evaluating the safety, tolerability, PK/PD, & efficacy of CRMA-1001 in adults with CHB across single & multiple-ascending dose cohorts, with enrollment ongoing Additionally, the company…

January 29, 2026

Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

Shots: The US FDA has approved Yuvezzi (carbachol & brimonidine tartrate ophthalmic solution) 2.75%/0.1%, previously known as Brimochol PF, for the treatment of presbyopia in adults; commercially available by Q2’26 Approval was backed by 2 P-III (BRIO I & BRIO II) trials (n>800), with BRIO I showing superior benefit vs individual actives & BRIO II…

January 29, 2026

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.,…

January 29, 2026

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Shots: The US FDA has approved Darzalex FASPRO (daratumumab and hyaluronidase-fihj) + bortezomib, lenalidomide & dexamethasone (D-VRd) for adults with NDMM who are ineligible for autologous stem cell transplant. Approval was based on the P-III (CEPHEUS) trial, assessing D-VRd vs VRd in 395 ASCT-ineligible or deferred patients across 13 countries in the EU, North America,…

January 28, 2026

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

Shots: The US FDA approved Myqorzo (aficamten) is now commercially available in the US for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms Myqorzo is a QD, oral cardiac myosin inhibitor available in 5, 10, 15, and 20 mg tablets and directly targets hypercontractility and LVOT obstruction…

January 28, 2026

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…

January 28, 2026

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

Shots: Boehringer Ingelheim and Simcere have entered a license and collaboration agreement to develop SIM0709, a preclinical TL1A/IL-23p19 bispecific antibody, for the treatment of inflammatory bowel disease (IBD) As per the deal, Boehringer Ingelheim gains global rights to the asset excluding Greater China, while Simcere is eligible for an upfront payment, milestones up to €1.058B…

January 28, 2026

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Shots: The US FDA has granted 510(k) clearance to ABANZA’s QuadLock Fixation System, a knotless, bidirectional, tension-adjustable device for anterior cruciate ligament (ACL) reconstruction In biomechanical testing under high-demand cyclic loading, QuadLock demonstrated <0.5 mm cyclic displacement representing a >500% reduction in cyclic displacement and >1,000 N pullout strength vs conventional fixation methods QuadLock is…

January 28, 2026

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

Shots: Health Canada has approved Gazyva (obinutuzumab) for adults with active lupus nephritis receiving standard therapy Approval was based on P-II (NOBILITY) & P-III (REGENCY) trials, where in REGENCY (n=271), 46.4% on Gazyva + SoC achieved CRR vs 33.1% on SoC. Gazyva’s safety profile was consistent with its well-established profile from haematology-oncology indications Gazyva is…

January 28, 2026

NEWS

Gedeon Richter Receives the CHMP Positive Opinion for Fylrevy for Hormone Replacement Therapy (HRT)

nChroma Bio Reports First Patient Dosing in P-I/II Trial of CRMA-1001 for HBV Infection

Tenpoint Therapeutics Reports the US FDA Approval of Yuvezzi to Treat Presbyopia

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

Johnson & Johnson Receives the US FDA’s Approval for Darzalex FASPRO Regimen to Treat Newly Diagnosed Multiple Myeloma (NDMM)

Cytokinetics Launches Myqorzo in the US for Obstructive Hypertrophic Cardiomyopathy

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

Boehringer Ingelheim and Simcere Pharmaceutical ~$1.26B Deal to Develop SIM0709

ABANZA Secures US FDA 510(k) Clearance for QuadLock Fixation System for ACL Reconstruction

Roche Receives the Health Canada Approval for Gazyva to Treat Active Lupus Nephritis

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