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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FDA grants accelerated approval to infigratinib for metastatic cholangiocarcinoma

28 May 2021 - Today, the FDA granted accelerated approval to infigratinib (Truseltiq, QED Therapeutics), a kinase inhibitor for adults ...

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First COVID-19 vaccine approved for children aged 12 to 15 in EU

28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...

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FDA approves first targeted therapy for lung cancer mutation previously considered resistant to drug therapy

28 May 2021 - Today, the U.S. Food and Drug Administration approved Lumakras (sotorasib) as the first treatment for adult patients ...

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Verrica Pharmaceuticals announces extension of FDA review period of its NDA for VP-102 for the treatment of molluscum contagiosum

28 May 2021 - Prescription Drug User Fee Act goal date extended by three months to 23 September 2021. ...

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NICE green lights Tremfya to treat active psoriatic arthritis

28 May 2021 - Janssen’s IL-23 inhibitor Tremfya has been accepted for NHS use by the UK’s NICE for the ...

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U.S. Food and Drug Administration approves Bristol Myers Squibb’s Zeposia (ozanimod), an oral treatment for adults with moderately to severely active ulcerative colitis

27 May 2021 - Bristol Myers Squibb is committed to making Zeposia accessible to appropriate patients who need it through the ...

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Tagrisso approved in the EU for the adjuvant treatment of patients with early stage EGFR mutated lung cancer

28 May 2021 - Approval based on unprecedented results from the ADAURA Phase 3 trial where Tagrisso reduced the risk ...

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Novartis receives FDA fast track designation for sabatolimab (MBG453) in myelodysplastic syndromes

25 May 2021 - Novartis today announced that the US FDA has granted fast track designation for sabatolimab (MBG453) for the ...

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Post-market review of opiate dependence treatment program medicines

28 May 2021 - On 24 March 2021 it was announced the Department of Health will conduct a post-market review ...

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Amazon looking at opening pharmacy stores in US

26 May 2021 - Amazon is considering the launch of brick and mortar pharmacies in the United States, Insider reported ...

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NASP applauds the Introduction of bipartisan legislation to reduce drug costs and support medication access for seniors with life-threatening specialised conditions

27 May 2021 - This week, a bipartisan group of lawmakers in the U.S. House and Senate introduced legislation to rein ...

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Insufficient data on use of inhaled corticosteroids to treat COVID-19

27 May 2021 - EMA’s COVID-19 taskforce is advising health care professionals that there is currently insufficient evidence that inhaled ...

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Ireland an outlier without access to new cell and gene therapy, report says

27 May 2021 - Upfront costs high but treatments may cut long-term expense and boost patient results. ...

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Democrats promised to lower drug prices, but plans are sputtering

26 May 2021 - With control of Congress and the White House, Democrats have an opportunity to bring down prescription ...

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FDA approves Biohaven's Nurtec ODT (rimegepant) for prevention: now the first and only migraine medication for both acute and preventive treatment

27 May 2021 - Nurtec ODT 75 mg is the first oral CGRP antagonist approved to prevent migraine. ...

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