FDA approval of Leqembi subcutaneous formulation charts path to combination therapies for Alzheimer's disease

29 August 2025 - Subcutaneous delivery increases accessibility and introduces potential for at home administration, following model of diabetes and ...

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Cipaglucosidase alfa and miglustat for the treatment of patients with late-onset Pompe disease

15 August 2023 - NICE has published evidence-based recommendations on the use of cipaglucosidase alfa (Pombiliti) with miglustat (Opfolda) for ...

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New treatments for people with chronic migraine and soft tissue sarcoma added to the PBS

14 August 2023 - From August 2023, Australians with chronic migraine and soft tissue sarcoma will have access to new ...

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Insurers won’t cover new Alzheimer’s treatment for some customers

12 August 2023 - Some private insurers are balking at paying for the first drug fully approved to slow mental ...

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How advocates pushed big pharma to cut tuberculosis drug prices

14 August 2023 - The world’s best tuberculosis drug was too expensive for sufferers—until advocates and a YouTube star changed almost ...

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FDA grants accelerated approval to elranatamab-bcmm for multiple myeloma

14 August 2023 - Today, the FDA granted accelerated approval to elranatamab-bcmm (Elrexfio, Pfizer), a bispecific B-cell maturation antigen directed ...

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US FDA approves first therapeutic indication for Revance’s Daxxify (daxibotulinumtoxinA-lanm) for injection for the treatment of cervical dystonia

14 August 2023 - Approval expands the Daxxify label to include efficacy data over the 52 week ASPEN repeat dose clinical ...

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In the case of a devastating disease, the FDA weighs an experimental drug’s muddled data and a desperate need

14 August 2023 - Emma Albee knows the experimental drug she takes is not a cure. It won’t allow her ...

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What Mark Cuban gets wrong about prescription drugs

10 August 2023 - Mark Cuban, the Dallas Mavericks owner and “Shark Tank” star, has been making headlines recently with his ...

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Valneva announces PDUFA date extension for Chikungunya virus vaccine candidate

14 August 2023 – Valneva today announced that the US FDA has revised the PDUFA action date for the biologics ...

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Updates from the Health Technology Assessment Policy and Methods Review Reference Committee (August 2023)

14 August 2023 - Additional documents are now available. ...

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Jacobio Pharma announces breakthrough therapy designation from China CDE for KRAS G12C inhibitor glecirasib for the treatment of pancreatic cancer

7 August 2023 - Jacobio Pharma today announced that Jacobio's in house KRAS G12C inhibitor glecirasib was granted breakthrough therapy designation ...

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FDA approves niraparib and abiraterone acetate plus prednisone for BRCA mutated metastatic castration-resistant prostate cancer

11 August 2023 - Today, the FDA approved the fixed dose combination of niraparib and abiraterone acetate (Akeega, Janssen Biotech), ...

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US FDA designates PYC's lead as a fast track development program

11 August 2023 - The Company is currently evaluating the safety/tolerability and efficacy of an investigational drug candidate with disease-modifying potential ...

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PHARMAC proposes widening access to a brain cancer treatment to help reduce the impact of a discontinuation

11 August 2023 - PHARMAC is proposing to widen access to temozolomide, an oral anti-cancer treatment, for people with a type ...

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Patient and citizen participation at the organisational level in health technology assessment: an exploratory study in five jurisdictions

8 August 2023 - While patient participation in individual health technology assessments has been frequently described in the literature, patient and ...

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