News

Articles

Steven J. Lynn previously held positions at FDA’s Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Office of Regulatory Affairs. 

RCA Announces New Executive Vice-President of Pharmaceuticals

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

President Trump announced a revised initiative designed to reduce what consumers pay for prescription drugs, while also promising to protect coverage for pre-existing health conditions.

Trump Health Policies Again Thrust Drug Pricing and Access into the Spotlight

FDA and EMA have accepted the biologics license application and marketing authorization application, respectively, for bimekizumab.

EMA and FDA Accept UCB’s Marketing Applications for Bimekizumab

UK's Prime Minister visited the site of the country’s VMIC in Oxfordshire, and met the teams working at the forefront of the national COVID-19 response.

UK Prime Minister Visits Team Behind the Vaccines Manufacturing and Innovation Centre

ISPE has released new guidance on the cleaning validation lifecycle, written by a group of experts and reviewed by regulators and practitioners.

ISPE Releases Cleaning Validation Guide

Moderna and Chiesi Group are collaborating on the discovery and development of mRNA therapeutics to treat pulmonary arterial hypertension.

Moderna, Chiesi Group Collaborate on Discovery and Development of mRNA Therapeutics

The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.

Korean MFDS Approves Celltrion’s IND for Phase II/III Trial of COVID-19 Treatment

The companies will receive upfront funding from the European Union for the scale-up of manufacturing capabilities at industrial sites in Belgium, Italy, Germany, and France.



Sanofi and GSK to Provide the EU with 300 Million Doses of its COVID-19 Vaccine Candidate

Fears about overly accelerated development programs has heightened demands for wider access to information on study protocols, statistical analysis plans, and early results.

COVID-19 Vaccine Concerns Prompt Clinical Trial Transparency

The agency sent a warning letter to Kalchem International for CGMP violations found at the company’s Lindsay, OK, facility.

Industry News