Quality Systems

Patrick Lavery is an Editor for the MJH Life Sciences brands 

. Previously at MJH, he filled the same role for 

Articles

Tenosynovial giant cell tumor (TGCT) is rare and non-malignant, forming in or near joints, but which if left untreated can cause damage to joints and surrounding tissue, potentially leading to significant disability.

FDA Grants Full Approval for Symptomatic Tenosynovial Giant Cell Tumor Treatment

Feliza Mirasol is the science editor for 

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

FDA Approves Evrysdi Tablet from Roche for Spinal Muscular Atrophy

With the approval, FDA granted SpringWorks a rare pediatric disease priority review voucher.

FDA Approves SpringWorks Therapeutics Treatment for Adult and Pediatric Patients with NF1-PN

Acoramidis was approved by FDA in November 2024 and is prescribed in the US under the brand name Attruby.

European Commission Approves BridgeBio Treatment for ATTR-CM

While this approval addresses breast cancer, olaparib in combination with durvalumab was approved by the EU in August 2024 for treatment of endometrial cancer.

Scottish Medicines Consortium Accepts AstraZeneca’s Breast Cancer Treatment

These infections can be caused by certain Gram-negative microorganisms, making the infections challenging to control due to high antimicrobial resistance.

FDA Approves AbbVie Treatment for Complicated Intra-Abdominal Infections

Another eight medications already authorized in the EU were recommended for extensions of various indications.

EMA Recommends Eight New Medicines for Approval in January 

Drug manufacturer Novo Nordisk said the approval establishes Ozempic as the most broadly indicated GLP-1 RA in its class.

FDA Approves Ozempic Indications for Reducing Risk of Kidney Failure, Cardiovascular Death

Data from a Phase III study that evaluated lazertinib, in combination with amivantamab, in comparison to osimertinib as a first-line treatment resulted in the EC’s decision.

European Commission Approves Johnson & Johnson Non-Small Cell Lung Cancer Treatment

Imfinzi received an expanded indication for lung cancer from FDA in August 2024, and Tagrisso had been approved to treat lung cancer in China in June 2024.

Regulatory Authority Actions