Novartis’ CAR-T cancer therapy has won the unanimous support of the FDA’s advisory committee, setting it up to win approval by October 3.
The FDA has hit Ocular Therapeutix with another complete response letter, wiping 30% off the company's stock.
With pressures to fast-track clinical development, the pharmaceutical industry recognizes the value of improving internal clinical data management processes.…
Amicus can now submit its rare disease drug for review, a year after being blocked.
An FDA greenlight for sickle cell therapy Endari has put developer Emmaus into the spotlight, but commercializing the drug could be challenging.
Ahead of the first-ever FDA AdComm for a CAR-T medication, the agency says experts should focus on the safety side of the new med.
The FDA and its new Trump-picked commissioner Scott Gottlieb took to social media to talk up plans to speed up the drug regulation process.
Shire has obtained a preliminary injunction to stop Roche spreading “inaccurate and misleading” statements about clinical trial data.
Silence Therapeutics has asked the U.K. High Court of Justice to rule on an intellectual property dispute with Alnylam and The Medicines Company.
Senior politicians in the British government have called for the country to work closely with the EMA after Brexit.
The delisting plan of Chinese vaccine maker Sinovac has been complicated by a bribery case and a new bid.