Pandemics. War. Political upheaval. Severe weather. Availability of energy supplies. Any of these can kink up the supply chain, making it difficult (and sometimes impossible) to get drugs to the…
Celgene and Bristol Myers Squibb (BMS) have used a pattern of unlawful patents to extend a monopoly in the market for Pomalyst (pomalidomide), a blockbuster drug used in the treatment…
The FDA has released a draft guidance on how it intends to determine whether sponsor-provided prescription drug software output should be treated as FDA-required labeling or promotional labeling and how,…
The best way to design trials around an artificial womb intended to better regulate body temperature and foster safer lung development in extremely premature infants (EPI) is the focus of…
Focusing on fostering a culture of quality in a drug manufacturing company seems obvious today — a given. But that wasn't always the case, explained industry veteran Sue Schniepp, a…
The FDA has offered greater direction on demonstrating substantial evidence of effectiveness for drugs and biologics, publishing draft guidance on whether a single trial plus confirmatory evidence will suffice for…
GSK’s Ojjaara (momelotinib), the first and only treatment for myelofibrosis patients with anemia regardless of prior myelofibrosis therapy, received FDA approval on Friday. Source: Drug Industry Daily
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Source: Drug Industry Daily
The FDA released two draft guidances for biosimilar manufacturers — one on labeling that focuses on prescribing information and the other on the FDA’s licensure requirements. Source: Drug Industry Daily
To combat allegations of political interference — which may have impacted HHS’ response to the COVID-19 pandemic — HHS agencies, including the FDA, are updating their scientific integrity policies and…