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An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. Read More
The UK’s drug pricing watchdog is recommending reimbursement of Celgene’s plaque psoriasis drug Otezla, provided that the company lowers its price. Read More
After nearly two years, the EMA is formalizing its iterative pathway program that saw six applications progress to formal advice from the agency, according to a report. Read More
The FDA is simplifying the process of developing written procedures for an IRB, providing industry with a comprehensive checklist that satisfies both FDA and HHS requirements. Read More
The EMA is mapping out trial designs for the development of therapies to treat Crohn’s disease, ulcerative colitis and mycobacterium tuberculosis. Read More