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NEWS

Corcept Therapeutics Reports the US FDA’s NDA Acceptance of Relacorilant to Treat Platinum-Resistant Ovarian Cancer

Shots: The US FDA has accepted NDA of relacorilant for the treatment of Pt-resistant ovarian cancer (PDUFA: Jul 11, 2026) NDA was supported by P-III (ROSELLA) & P-II trials, where relacorilant + nab-paclitaxel demonstrated improved PFS & OS compared to nab-paclitaxel monotx., with no need for biomarker selection & favorable safety Additionally, relacorilant (GR antagonist)…
September 11, 2025

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Medison and Ipsen’s Bylvay Receives the Health Canada’s Approval to Treat Cholestatic Pruritus in Alagille Syndrome Patients

Shots: Health Canada has approved Bylvay (odevixibat) for the treatment of cholestatic pruritus in pts (≥12mos.) with Alagille Syndrome (ALGS) Approval was based on P-III (ASSERT) trial assessing Bylvay (120µg/kg, QD) vs PBO in ALGS pts for 24wks. across North America, EU, Middle East, & Asia Pacific regions Trial met its 1EP of improved pruritus…
September 10, 2025

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Amgen and Kyowa Kirin Report Topline P-III (ASCEND) Study Results of Rocatinlimab in Moderate to Severe Atopic Dermatitis

Shots: The P-III (ASCEND) trial evaluated rocatinlimab (150 or 300mg, Q4W/Q8W) in ~2,600 atopic dermatitis pts who completed 24wks. in ROCKET trial program & continued for 32wks. in ASCEND, which will evaluate long-term safety & efficacy up to 104wks. Trial showed a favorable long-term safety profile (1EP) with low discontinuation rates due to AEs, consistent…
September 9, 2025

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NEWS

Novartis to Acquire Tourmaline Bio for ~$1.4B, Complementing its Cardiovascular Portfolio

Shots: Novartis has entered into an agreement to acquire Tourmaline Bio, incl. its asset pacibekitug, expanding its cardiovascular portfolio As per the deal, Novartis, through its subsidiary, will acquire Tourmaline for $48/share, representing an aggregate of ~$1.4B, & will merge the subsidiary into Tourmaline upon completion, making it an indirect wholly owned unit of Novartis; closing…
September 9, 2025

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Eli lilly
NEWS

Eli Lilly Reports P-III (BRUIN CLL-313) Trial Data on Jaypirca for 1L Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Shots: Eli Lilly has reported P-III (BRUIN CLL-313) trial data assessing Jaypirca (pirtobrutinib; 200mg, PO, QD) vs chemoimmunotherapy (bendamustine + rituximab) in 282 pts with 1L chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) without 17p deletions Trial met its 1EP of improved PFS per IRC, while OS was immature but showed a favorable trend &…
September 8, 2025

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Astrazeneca
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AstraZeneca Reports P-III (FLAURA2) Trial Findings on Tagrisso Regimen to Treat EGFRm NSCLC

Shots: AstraZeneca has reported P-III (FLAURA2) trial findings on Tagrisso + Pt-based CT as a 1L treatment of pts with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC The P-III (FLAURA2) trial assessed Tagrisso (80mg, QD, PO) + pemetrexed + cisplatin/carboplatin (Q3W for 4 cycles) followed by Tagrisso + pemetrexed maintenance (Q3W) vs…
September 8, 2025

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Takeda
NEWS

Takeda’s Vonvendi Receives the US FDA’s Approval for Adults and Children with Von Willebrand Disease

Shots: FDA has approved a label extension for Vonvendi to incl. routine prophylaxis for reducing bleeding in adults with Type 1 & 2 von Willebrand disease (VWD), & for on-demand & perioperative bleeding management in pediatric pts Approval was backed by extensive data, incl. a P-III trial in adults, a P-III trial in children, a P-IIIb continuation…
September 8, 2025

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Genentech
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Genentech Presents Long-Term Efficacy and Safety Data on Vabysmo for Wet Age-Related Macular Degeneration

Shots: Genentech has reported new data from the open-label AVONELLE-X & P-IIIb/IV (SALWEEN) studies of Vabysmo (faricimab-svoa) at Euretina’25 The 2yr. AVONELLE-X study was an extension of P-III (TENAYA & LUCERNE) trials, showing maintained vision & anatomy in wet AMD, with ~80% pts extending dosing to Q3M/Q4M after ~4yrs. of therapy SALWEEN study in Asia…
September 5, 2025

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