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FDA awards Orphan Drug Designation to SynaptixBio for rare brain disease therapy

Isolated hypomyelination is a form of TUBB4A leukodystrophy that has been identified relatively recently

- PMLiVE

FDA approves Allecra’s combination antibiotic Exblifep for complicated UTIs

Complicated UTIs account for approximately 19% of all healthcare-associated infections

- PMLiVE

FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar

Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease

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Pfizer’s Litfulo recommended by NICE as first treatment for severe alopecia areata

Up to 14,000 patients living with the autoimmune disease could benefit from NICE’s decision

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Johnson & Johnson’s Tecvayli receives FDA approval for reduced dosing in multiple myeloma patients

More than 35,000 cases of the blood cancer are expected to be diagnosed in the US this year

- PMLiVE

Pfizer’s Velsipity granted EC approval for ulcerative colitis in patients aged from 16 years

The immune-mediated inflammatory bowel disease affects approximately 2.6 million people in Europe

- PMLiVE

AstraZeneca’s Tagrisso combination approved by FDA for advanced lung cancer

An estimated 200,000 people in the US are diagnosed with lung cancer every year

- PMLiVE

FDA approves Iovance’s Amtagvi as first cellular therapy for advanced melanoma

Amtagvi is now the first one-time, individualised T cell therapy to be approved in the US for a solid tumour cancer

- PMLiVE

Takeda’s Eohilia approved by FDA as first oral therapy for eosinophilic oesophagitis

The inflammatory disease affects around one in 2,000 people in the US

- PMLiVE

Ipsen’s Onivyde regimen granted FDA approval to treat pancreatic cancer

Around 60,000 people are diagnosed with pancreatic adenocarcinoma in the US every year

- PMLiVE

Pfizer/BioNTech’s COVID-19 vaccine available to buy in UK following MHRA endorsement

The XBB.1.5-adapted vaccine will be available for purchase from March 2024

- PMLiVE

GSK’s RSV vaccine granted FDA priority review for use in adults aged 50 to 59 years

Arexvy has already been approved in the US and Europe to protect those aged 60 years and older

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