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This year’s PC Podcast episodes ranged in topic, from DSCSA compliance to pharmacovigilance.

Top 3 Podcast Episodes of the Year

A panel designs a conceptual framework in an effort to limit partiality. 

Mitigating Bias in Healthcare Algorithm Development

If the FDA approves the sBLA for Xolair, it would be the first drug indicated to lower allergic reactions to multiple foods after an accidental exposure.

Biologics License Application for Xolair Granted FDA Priority Review for Food Allergies

If the FDA approves garadacimab, it would be the first approved hereditary angioedema therapy that targets activated FXIIa.

FDA to Review BLA for CSL Behring's Novel Treatment for Hereditary Angioedema 

Filsuvez is indicated to treat wounds associated with junctional epidermolysis bullosa and dystrophic epidermolysis bullosa in patients aged 6 months and older. 

Filsuvez Topical Gel Approved by FDA for Wounds Associated With Epidermolysis Bullosa 

Merck’s Biologics License Application for V116, a 21-valent pneumococcal conjugate vaccine, was given a Prescription Drug User Fee Act (PDUFA) date of June 17, 2024.

Biologics License Application for 21-Valent Pneumococcal Vaccine Granted FDA Priority Review

FDA expands indication for LEO Pharma’s Adbry (tralokinumab-ldrm) to include patients 12 to 17 years of age with moderate-to-severe atopic dermatitis.

FDA Approves Expanded Indication for Adbry in Atopic Dermatitis 

Moderna previously filed marketing authorization submissions for mRNA-1345 for the prevention of RSV-associated lower respiratory tract disease and acute respiratory disease in adults aged 60 years and older.

Novel Vaccine Against Respiratory Syncytial Virus Shows Significant Efficacy

Jemperli has shown potential both as a monotherapy and in combination with standard of care and future novel cancer therapies, particularly in patients with currently limited treatment options.

Jemperli Combination Significantly Improves Survival in Primary Advanced, Recurrent Endometrial Cancer 

Arcutis Biotherapeutics said Zoryve foam will be widely available via key wholesaler and dermatology pharmacy channels by the end of January 2024.

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