US FDA approves Boehringer’s Jascayd (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade

9 October 2025 - Approval is based on results from two clinical trials, which showed reduction in forced vital capacity decline ...

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Why the Government must urgently raise the NICE cost effectiveness threshold

7 October 2025 - NICE plays an important role in determining whether new medicines will be funded for NHS patients ...

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Ascendis submits marketing authorisation application to the EMA for TransCon CNP for treatment of children with achondroplasia

8 October 2025 - Ascendis Pharma today announced it has submitted a marketing authorisation application to the EMA for TransCon CNP ...

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Richter and Hikma receive FDA approval for denosumab biosimilars Enoby and Xtrenbo, referencing Prolia and Xgeva

29 September 2025 - Gedeon Richter and Hikma Pharmaceuticals announce today that the US FDA has granted approval for the ...

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Donald Trump’s cure for drug prices is worse than the disease

2 October 2025 - Few things infuriate Americans as much as drug prices. Republicans and Democrats alike agree that poorly patients ...

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Xspray Pharma provides update on the FDA process for Dasynoc – observations at contract manufacturer delay approval

8 October 2025 - Xspray Pharma has received a complete response letter from the US FDA concerning the Company’s new ...

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Werewolf Therapeutics receives fast track designation from the US FDA for WTX-124, an investigational therapy for the treatment of cancer

8 October 2025 - Werewolf Therapeutics today announced that the Company has received fast track designation for the use of WTX-124 ...

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Vivace Therapeutics' VT3989 granted fast track designation by the US FDA for the treatment of mesothelioma

8 October 2025 - Vivace Therapeutics today announced that the US FDA has granted fast track designation to VT3989, the company's ...

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Britain prepares NHS drug spending hike to stave off Trump tariffs

8 October 2025 - The UK Government has drawn up proposals to increase the amount the National Health Service pays ...

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FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma

8 October 2025 - Today, the FDA approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals) for the adjuvant treatment of adults with cutaneous ...

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Ontario connecting patients to life-saving cancer drugs faster

7 October 2025 - The Ontario Government is leading the world in cancer care by launching the Funding Accelerated for ...

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US FDA approves Simponi (golimumab) for the treatment of paediatric ulcerative colitis

7 October 2025 - Johnson & Johnson today announced that the US FDA has approved Simponi (golimumab) for the treatment of ...

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Enhertu plus pertuzumab supplemental new drug application submitted in Japan as first-line therapy for patients with HER2 positive metastatic breast cancer

7 October 2025 - Submission based on DESTINY-Breast09 Phase 3 trial results that showed Enhertu plus pertuzumab reduced the risk ...

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Jesse's dad, who walked Canada for his son, cheers approval of new Duchenne drug

3 October 2025 - Vamorolone is the first Health Canada approved drug developed specifically to treat Duchenne. ...

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Kashiv Biosciences announces submission of biologics license application to US FDA and acceptance of market authorisation application by EMA for ADL-018, a proposed biosimilar to Xolair (omalizumab)

6 October 2025 - Kashiv BioSciences announced that they have submitted a biologics license application to the US FDA, and ...

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