ICER releases white paper on accelerated approval pathway for prescription drugs

16 April 2026 - The ICER, in collaboration with Verdant Research, has published a new white paper today that examines the ...

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Savara announces the US FDA has extended the review period for the molgramostim inhalation solution biologics license application in autoimmune pulmonary alveolar proteinosis

15 April 2026 - Savara today announced that the FDA has extended the review period for the molgramostim BLA in ...

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Health Canada approves Cysklar (cysteamine ophthalmic solution) 0.44% for treatment of corneal crystals in people with cystinosis

15 April 2026 - Leadiant Biosciences today announced that Health Canada has approved Cysklar (cysteamine ophthalmic solution) 0.44%, a topical eye ...

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The Australian Government is continuing to deliver cheaper medicines with Australians living with lung or bladder cancer to pay less for new and expanded PBS medicines

16 April 2026 - The Australian Government is continuing to deliver cheaper medicines with Australians living with lung or bladder ...

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Health Canada approves neffy - the first needle free epinephrine spray for anaphylaxis

15 April 2026 - ALK-Abello today announced that Health Canada has approved neffy 2 mg for the emergency treatment of ...

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Opna Bio announces fast track designation granted to OPN-6602 for the treatment of multiple myeloma

15 April 2026 - Opna Bio today announced that the US FDA has granted fast track designation to OPN-6602, a dual ...

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Arbutus receives US FDA fast track designation for imdusiran for the treatment of chronic hepatitis B

15 April 2026 - Arbutus Biopharma today announced that the US FDA has granted fast track designation for imdusiran for the ...

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Partner Therapeutics announces submission of supplemental biologics license application to FDA for Bizengri (zenocutuzumab-zbco) in NRG1 fusion positive cholangiocarcinoma

14 April 2026 - Partner Therapeutics announces the submission of a supplemental biologics license application to the US FDA for Bizengri ...

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Aligos Therapeutics announces first interim analysis results from the Phase 2 B-SUPREME study of pevifoscorvir sodium in participants with chronic hepatitis B virus infection and grant of FDA fast track designation

14 April 2026 - Aligos Therapeutics today announced the first interim analysis results of the Phase 2 B-SUPREME study of pevifoscorvir ...

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Praxis Precision Medicines announces FDA acceptance of new drug application for ulixacaltamide hydrochloride in patients with essential tremor

14 April 2026 - - Praxis Precision Medicines today announced that the US FDA has accepted for review its new drug ...

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My brother can’t access a just approved breakthrough drug for his rare disease

14 April 2026 - A new therapy for Hunter syndrome highlights the inequities of age-based approvals. ...

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Teenager with debilitating illness fights for affordable life-changing medication

13 April 2026 - Brave South Australian teenager Mia McCarthy feels she’s one of “the lucky ones”, despite living with ...

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Cancer patient’s plea for Pfizer to rejoin PBS talks on breakthrough drug

14 April 2026 - Pharmaceutical giant Pfizer has abandoned negotiations to have a breakthrough cancer drug listed on the Pharmaceutical ...

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Travere Therapeutics announces full FDA approval of Filspari (sparsentan), the first and only approved medicine for FSGS

13 April 2026 -  Travere Therapeutics today announced that the US FDA has approved Filspari (sparsentan) to reduce proteinuria in adult ...

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Saphnelo subcutaneous approved in Canada for the treatment of systemic lupus erythematosus

13 April 2026 - Health Canada has granted a notice of compliance for Saphnelo (anifrolumab injection) for subcutaneous self-administration via a ...

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