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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ICER publishes white paper evaluating reforms to orphan drug development, pricing and coverage

7 April 2022 - The white paper presents an analysis of the potential risks and benefits of reforms seeking to ...

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NICE says new triple negative advanced breast cancer drug too expensive for NHS use

7 April 2022 - NICE has today issued draft guidance which does not recommend sacituzumab govitecan for treating locally advanced or ...

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A radical treatment for insulin pricing

6 April 2022 - A private, non-profit company recently announced that it intends to bypass the traditional supply chain and sell ...

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TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (Xevudy) for the BA.2 omicron sublineage

7 April 2022 - The TGA has received an application from GSK for a higher (1,000 mg) dose of its ...

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Hundreds of people with some forms of urothelial cancer to receive new treatment

7 April 2022 - Over 800 people with locally advanced or metastatic urothelial cancer are set to benefit from a new ...

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Innovent announces the approval of Pemazyre (pemigatinib) by the NMPA for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement as confirmed by a validated diagnostic test that have progressed after at least one prior line of systemic therapy

6 April 2022 - Innovent Biologics announced that the National Medical Products Administration has approved Pemazyre (pemigatinib) for the treatment of ...

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COVID-19 vaccine weekly safety report (7 April 2022)

7 April 2022 - To 3 April 2022, the TGA has received 511 reports which have been assessed as likely to ...

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TGA approves yet another new medicine for patients with psoriasis

7 April 2022 - Bimekizumab is a humanised immunoglobulin G1 kappa monoclonal antibody. It has two identical antigen binding regions that ...

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Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation

7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung ...

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BeiGene announces European Medicines Agency acceptance of marketing authorisation applications for tislelizumab for the treatment of patients with ESCC and NSCLC

6 April 2022 - First European submissions for BeiGene’s anti PD-1 antibody licensed to Novartis for North America, Europe and ...

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Some hoped FDA approval of Pfizer's COVID vaccine would convince unvaccinated Americans. It didn't, study finds.

6 April 2022 - After the Food and Drug Administration approved Pfizer-BioNTech’s COVID-19 vaccine in August, public health experts were ...

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Eligible individuals can receive second COVID-19 booster shot at no cost

6 April 2022 - Today, the Centers for Medicare & Medicaid Services announced it will pay for a second COVID-19 booster ...

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Inside a campaign to get Medicare coverage for a new Alzheimer’s drug

6 April 2022 - The Alzheimer’s Association has pushed relentlessly to get broad access to Aduhelm, despite safety risks and ...

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U.S. FDA aims to decide on strain selection for COVID boosters by June

6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...

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BioXcel Therapeutics announces FDA approval of Igalmi (dexmedetomidine) sublingual film for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults

6 April 2022 - U.S. commercial launch planned for Q2 2022. ...

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