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Accord BioPharma Reports the US FDA Approval of Immgolis and Immgolis Intri (Biosimilar, Simponi and Simponi Aria)
Shots: The US FDA has approved Immgolis & Immgolis Intri, the interchangeable biosimilar versions of Simponi & Simponi Aria (golimumab), respectively Immgolis & Immgolis Intri are both approved for the treatment of adults with mod. to sev. active rheumatoid arthritis in combination with methotrexate, while Immgolis is additionally approved for mod. to sev. active ulcerative…
May 19, 2026
Regeneron Inks a ~$2.3B Deal with Parabilis Medicines to Advance Antibody-Helicon Conjugates Across Multiple Therapeutic Areas
Shots: Regeneron has entered a strategic research collaboration with Parabilis to discover & develop multiple therapeutics using Parabilis’ Helicon peptide platform, with a focus on Antibody-Helicon Conjugates (AHCs) Regeneron will lead development, manufacturing, & global commercialization, while Parabilis will receive $125M, incl. $50M upfront & a $75M commitment toward its next equity financing, subject to…
May 18, 2026
PainTEQ Launches TRAQ SI Joint Fusion Implant in the US
Shots: PainTEQ has launched TRAQ SI Joint Fusion, a posterior sacroiliac joint implant designed for bi-cortical fixation through engagement of both the sacral & iliac cortices using a tissue-sparing posterior approach, in the US TRAQ SI Joint Fusion is delivered through a 1-inch incision & features triangular piercing barbs engineered to stabilize the SI joint…
May 18, 2026
Genentech Reports FDA Approval of Tecentriq and Tecentriq Hybreza for Adjuvant Muscle-Invasive Bladder Cancer With ctDNA-Guided Treatment
Shots: FDA approved Genentech's Tecentriq & Tecentriq Hybreza (atezolizumab & hyaluronidase-tqjs) as an adj. therapy for adults with MIBC who have ctDNA MRD after cystectomy, as identified by Natera’s Signatera CDx MRD assay, which received simultaneous FDA approval Approval was based on the P-III (IMvigor011) trial evaluating Tecentriq vs PBO in adults with MIBC & ctDNA…
May 18, 2026
Protara Therapeutics Reports P-II (ADVANCED-2) Trial on TARA-002 in BCG-Naïve Non-Muscle Invasive Bladder Cancer (NMIBC)
Shots: Protara has reported 12mos. data from Cohort A of the ongoing P-II (ADVANCED-2) trial assessing TARA-002 in pts with carcinoma in situ or CIS (± Ta/T1) NMIBC who are BCG-Unresponsive or BCG-Naïve; P-III (ADVANCED-3)trialin BCG-Naïve pts to initiatein H2’26 The BCG-Naïve group (n=31), incl. 29 evaluable pts for efficacy, with 27 evaluable at 6mos.…
May 15, 2026
Resurge Therapeutics Presents Clinical Results on its Intraprostatic Drug Elution (IPDE) Platform for Benign Prostatic Hyperplasia (BPH) at AUA 2026
Shots: The 2 studies evaluated IPDE therapy for lower urinary tract symptoms (LUTS) secondary to BPH, assessing delivery of paclitaxel-eluting bioabsorbable implants through transperineal & transrectal approaches In the transperineal study (n=20), IPDE improved IPSS by 15 points & Qmax by ~4 mL/s at 1yr., achieving benefit in 80% pts, while the transrectal study (n=11)…
May 15, 2026
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