Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Combination products may be reviewed in a single application or in separate applications for each constituent part, and in rare cases, FDA may decide which type of application process is appropriate.

FDA Issues Combination Product Application User Fee Guidance for Staff and Industry

While the document does not address treatment or prevention of the long-term complications of ulcerative colitis or Crohn’s disease in children, it aims to help sponsors developing drugs for pediatric patients currently affected.

FDA Draft Guidance Seeks to Support Drug Developers for Pediatric Inflammatory Bowel Disease

Roche voluntarily recalled Susvimo’s ocular implant, insertion tool, and initial fill kit when test results did not satisfy company standards.

Roche to Reintroduce nAMD Treatment in US After FDA Approves Updates

Other indications for which the Sanofi treatment has been approved include atopic dermatitis, asthma, and chronic rhinosinusitis.

EU Makes First-in-World Approval of Dupixent as Targeted Therapy for Uncontrolled COPD

Kisunla (donanemab-azbt) reduced amyloid plaques in Phase III study participants by 84% after 18 months.

FDA Approves Lilly Treatment for Early Symptomatic Alzheimer’s Disease

Mike Hennessy Jr. is the President and CEO of 

A greater number of patients with Duchenne muscular dystrophy will be able to be treated after FDA's approval of a gene therapy.

Publisher's Note: With Age Comes Wisdom

Feliza Mirasol is the science editor for 

GSK’s application for using Jemperli (dostarlimab) plus chemotherapy for all adult patients with primary advanced or recurrent endometrial cancer has been accepted by the EMA.

GSK’s Application for Jemperli Plus Chemotherapy for Use in All Patients with Endometrial Cancer Accepted by EMA

EMA’s CHMP gave positive opinions on a nasal delivery for epinephrine and for a first-in-class medicine to treat pulmonary arterial hypertension, among others, including a biosimilar for treatment of autoimmune diseases.

First Nasal Adrenaline Spray Among EMA Approvals in June

The seven chosen sponsors will help accelerate development of novel drugs and biologics for rare diseases.

Participants for START Pilot Program Selected by FDA

Results of a Phase III trial showed that Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death associated with EGFR-mutated non-small cell lung cancer by 44%.

Regulatory Filings and Submissions