Delgocitinib for the treatment of patients with moderate to severe chronic hand eczema

8 July 2025 - The Department of Health and Social Care has asked NICE to produce guidance on the use ...

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Zanubrutinib for the treatment of patients with relapsed or refractory mantle cell lymphoma

10 July 2025 - NICE has published final evidence-based recommendations on the use of zanubrutinib for the treatment of adults ...

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European Commission approves Tevimbra in combination with chemotherapy as a first-line treatment for nasopharyngeal carcinoma

10 July 2025 - New indication based on results of RATIONALE-309 study demonstrating statistically significant improvement in progression-free survival. ...

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Milestone Pharmaceuticals announces FDA acceptance of the company’s response to the CRL for Cardamyst (etripamil) nasal spray

11 July 2025 - New PDUFA action date of 13 December 2025. ...

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Transcend Therapeutics receives breakthrough therapy designation for TSND- 201 (methylone) for the treatment of PTSD

10 July 2025 - Company planning to initiate Phase 3 program. ...

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Zepbound KwikPen (tirzepatide), the first and only dual receptor agonist for the treatment of obesity, now approved and available in Canada

9 July 2025 - Eli Lilly Canada is pleased to announce that Zepbound KwikPen (tirzepatide injection) is now available in Canada, ...

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Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma

8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...

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FDA grants fast track designation for TRE-515 in combination with radiation therapy for the treatment of metastatic castration resistant prostate cancer

9 July 2025 - Trethera announced today that the US FDA has granted fast track designation for its novel drug, TRE-515, ...

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MHRA approves elinzanetant to treat moderate to severe vasomotor symptoms (hot flushes) caused by menopause

8 July 2025 - The MHRA has today become the first regulator in the world to approve elinzanetant (Lynkuet) for the ...

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Albanese should consider tweaks to PBS to avoid Trump tariff: CSL chair

9 July 2025 - Donald Trump’s move to ramp up tariffs on medicines and copper has sparked alarm among government ...

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FDA approves updated label for Lilly's Kisunla (donanemab-azbt) with new dosing in early symptomatic Alzheimer's disease

9 July 2025 - The newly recommended dosing schedule significantly lowered ARIA-E rates compared to the original dosing schedule, adding ...

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New Wegovy dose submitted to EMA for approval, with 1 in 3 trial participants achieving 25% or more weight loss

8 July 2025 - Novo Nordisk today announced the submission of an application to the EMA for approval of a new, ...

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Supplemental new drug application submitted to US FDA for Caplyta (lumateperone) with data demonstrating significant schizophrenia relapse prevention compared to placebo

8 July 2025 - Submission is based on long-term Phase 3 data demonstrating 63 percent reduction in risk of relapse in ...

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PBS ‘not on the table’ in battle for pharmaceutical tariff exemption, despite lobbying

9 July 2025 - The threat of global 200 per cent tariffs on pharmaceutical products presents a challenge to Australia’s drug ...

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Drug reimbursement panel approves iptacopan for PNH reimbursement, rejects danicopan over cost concerns

7 March 2025 - The Pharmaceutical Reimbursement Review Committee has made mixed decisions on the two medicines for paroxysmal nocturnal ...

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