Regulatory Oversight and Compliance

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

February 13, 2025

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

European Commission Approves BridgeBio Treatment for ATTR-CM

February 12, 2025

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

Scottish Medicines Consortium Accepts AstraZeneca’s Breast Cancer Treatment

February 11, 2025

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

FDA Approves AbbVie Treatment for Complicated Intra-Abdominal Infections

February 10, 2025

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

Introducing a New Legal Framework, Fees, and Charges

February 03, 2025

EMA introduced its New Fee Regulation in January 2025, but what impact will the new fees and charges have on medicine developers?

The Social Media Code

February 02, 2025

Bio/pharma companies have a lot to consider when tackling social media communications, especially within Europe.

EMA Recommends Eight New Medicines for Approval in January

February 02, 2025

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

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

January 29, 2025

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

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

January 28, 2025

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.

Two AstraZeneca Treatments Recommended for Lung Cancer Patients in England and Wales

January 23, 2025

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.