Halda Therapeutics receives FDA fast track designation for HLD-0915 for the treatment of metastatic castration-resistant prostate cancer

14 August 2025 - Halda Therapeutics today announced that the US FDA granted fast track designation to HLD-0915, the company’s ...

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DoH publishes revised agenda for November 2025 PBAC meeting (version 2)

20 August 2025 - The DoH has published a revised agenda for the November 2025 PBAC meeting. ...

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Leqvio advances toward broader access with agreement between Novartis and the pan-Canadian Pharmaceutical Alliance

21 August 2025 - Eligible Canadian patients with heterozygous familial hypercholesterolaemia are one step closer to publicly funded access to ...

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Breakthrough life-extending combination treatment for advanced bladder cancer recommended by NICE

21 August 2025 - NICE has recommended a new first-line treatment for adults with advanced bladder cancer, marking a significant ...

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Health Canada grants marketing authorisation for an additional indication of Bayer's Nubeqa (darolutamide) for the treatment of metastatic castration-sensitive prostate cancer

21 August 2025 - Bayer is pleased to announce that Health Canada has granted marketing authorisation for its oral androgen receptor ...

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Japan’s PMDA had shortest review times for new drugs, half of drugs submitted to US first

20 August 2025 - According to a recent analysis, Japanese regulators have the shortest time to approval for new drugs compared ...

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VeonGen Therapeutics receives FDA regenerative medicine advanced therapy designation for VG801 gene therapy for Stargardt disease

21 August 2025 - VeonGen Therapeutics today announced that the US FDA has granted regenerative medicine advanced therapy designation to VG801, ...

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Stealth BioTherapeutics announces FDA acceptance of elamipretide NDA resubmission

21 August 2025 - - Stealth BioTherapeutics announced today that the US FDA has accepted for review the resubmission of the ...

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Dawnzera (donidalorsen) approved in the US as first and only RNA targeted prophylactic treatment for hereditary angioedema

21 August 2025 - Offers longest dosing option for hereditary angioedema, with dosing every 4 or 8 weeks. ...

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Rhythm Pharmaceuticals announces FDA acceptance of sNDA for setmelanotide in acquired hypothalamic obesity

20 August 2025 - US FDA accepts sNDA for filing with priority review; sets PDUFA goal date of 20 December 2025. ...

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BioAegis Therapeutics awarded second FDA fast track designation for recombinant human gelsolin to treat inflammasome driven decompression sickness

20 August 2025 - Second fast rrack designation in recent months highlights broad potential of rhu-pGSN across multiple diverse inflammation-driven ...

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Izalontamab brengitecan (EGFRxHER3 ADC) granted breakthrough therapy designation by US FDA for patients with previously treated advanced EGFR mutated non-small cell lung cancer

18 August 2025 - First breakthrough therapy designation in the US for SystImmune and Bristol Myers Squibb’s izalontamab brengitecan based ...

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Eylea HD (aflibercept) injection 8 mg applications for expanded US label and pre-filled syringe receive FDA review period extension

20 August 2025 - Regeneron Pharmaceuticals today announced that the US FDA has extended the target action dates to the fourth ...

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Aldeyra Therapeutics receives fast track designation for ADX‑2191 for the treatment of retinitis pigmentosa

19 August 2025 - 025-- Aldeyra Therapeutics today announced that the US FDA has granted fast track designation for ADX-2191 (methotrexate ...

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First of its kind Ozempic listing for kidney disease

19 August 2025 - Regulators have approved Ozempic’s use for kidney disease treatment, opening the door to new combination therapies. ...

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Madrigal receives European Commission approval for Rezdiffra (resmetirom) for the treatment of MASH with moderate to advanced liver fibrosis

19 August 2025 - Conditional marketing authorisation is based on positive results from the pivotal Phase 3 MAESTRO-NASH trial demonstrating Rezdiffra ...

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