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Fapon Biopharma
NEWS

Fapon Biopharma Reports the US FDA Approval of IND Application for FP008 to Treat Solid Tumors

Shots: The company received the US FDA’s approval on the IND application of FP008 to treat pts with solid tumors refractory to anti-PD-1 therapy FP008 exhibited safety, PK, and developability in cynomolgus monkey; currently seeking global strategic partnerships to co-develop FP008 through clinical trials & commercialization FP008 is an anti-PD-1×IL-10M fusion protein with a…
February 28, 2025

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Abbvie
NEWS

The CHMP Adopts Positive Opinion for AbbVie’s Rinvoq (Upadacitinib) to Treat Giant Cell Arteritis in Adults

Shots: The CHMP has recommended Rinvoq (15mg; QD) for the treatment of Giant Cell Arteritis (GCA) in adults with the EC’s decision expected in H1’25 Opinion was based on P-III (SELECT-GCA) trial assessing safety & efficacy of Rinvoq, where GCA pts (≥50yrs.) in first study period received either Rinvoq (7.5/15mg, QD) + 26wk. corticosteroid (CS) taper…
February 28, 2025

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GRIN Therapeutic
NEWS

GRIN Therapeutics Reports the US FDA’s Breakthrough Therapy Designation for Radiprodil to Treat Seizures in GRIN-Related Neurodevelopmental Disorder

Shots: The US FDA has granted BTD to radiprodil for the treatment of seizures in GRIN-related neurodevelopmental disorder harboring GoF mutations Designation was supported by P-Ib (Honeycomb) trial data of radiprodil in pediatric pts, showing 86% decrease in CMS frequency. 71% had >50% CMS reduction, & 6–7 were seizure-free for ≥80% of the 8wk.…
February 27, 2025

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Telix Pharmaceuticals
NEWS

Telix Pharmaceuticals Reports the US FDA’s BLA Acceptance with Priority Review of Zircaix (89Zr-DFO-girentuximab) for Kidney Cancer Imaging

Shots: The US FDA has accepted BLA & granted Priority Review to Zircaix (TLX250-CDx) for the detection of clear cell renal cell cancer (ccRCC) in pts (PDUFA: 27 Aug 2025). Expected to launch in 2025 BLA was based on P-III (ZIRCON) study assessing sensitivity & specificity of 89Zr-TLX250 in adult pts (n=300), where 284 evaluable…
February 26, 2025

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Merck
NEWS

Merck Reports the US FDA’s sBLA Acceptance of Neoadjuvant Keytruda with Priority Review for Locally Advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC)

Shots: The US FDA has accepted sBLA & granted priority review to neoadj. Keytruda followed by adj. Keytruda + SoC radiotherapy ± cisplatin & then as a single agent to treat operable LA-HNSCC (PDUFA: Jun 23, 2025) sBLA was based on P-III (KEYNOTE-689) trial data assessing neoadj. Keytruda (200mg, IV, Q3W × 2 cycles), followed by…
February 26, 2025

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Gilead
NEWS

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots: The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…
February 25, 2025

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Takeda
NEWS

Takeda Reports EMA Approval for Additional SC Administration Option of Takhzyro (lanadelumab) for Patients aged ≥12 with Recurrent HAE

Shots: Takeda reported the EMA's approval of an additional 2 mL pre-filled pen option for Takhzyro (lanadelumab) for patients aged ≥12 with Recurrent hereditary angioedema (HAE) Currently Takhzyro is approved in 150 mg and 300 mg pre-filled syringes and 300 mg vial. The new approval is for a 300 mg pre-filled pen (2 mL…
February 25, 2025

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Mirum Pharmaceuticals
NEWS

Mirum Pharmaceuticals Receives the US FDA Approval for Ctexli to Treat Cerebrotendinous Xanthomatosis

Shots: The US FDA has approved Ctexli (chenodiol) to treat cerebrotendinous xanthomatosis (CTX) in adults Efficacy was established in crossover withdrawal P-III (RESTORE) trial assessing Ctexli (250mg, PO, TID) vs PBO in pts for 24wks. Study showed reduced levels of plasma cholestanol & urine 23S-pentol in pts compared to PBO Ref: Prnewswire | Image: Mirum Related…
February 24, 2025

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NEWS

Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra)

Shots: Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev.…
February 24, 2025

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