Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.
FDA’s CRL transparency policy is boosting biopharma accountability Read More »
The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.
FDA flexibility isn’t absent but evolving regulations come with growing pains Read More »
Habiendo completado buena parte del trayecto de vuelta a la Tierra, los astronautas de la misión Artemis 2 afrontaron una anomalía técnica inesperada en las comunicaciones entre su nave Orión y la Tierra. Se perdió la señal durante una transmisión de …
Llegan a la Tierra los astronautas de la misión lunar Artemis 2 Read More »
Mergers and acquisitions in the first quarter hit multi-year highs after providers pumped the brakes last year on deal-making due to financial stress and policy uncertainty from Washington, according to a new study from Kaufman Hall.
The FDA in a complete response letter to Replimune maintained its original objection to the single-arm trial the biotech used to support the application for RP1.
Replimune’s advanced melanoma drug rebuffed by FDA for second time Read More »
The agency showcased dozens of tools Thursday, about 8 months after the CMS first announced the initiative that aims to ease health data sharing and improve access to digital health and AI products.
CMS unveils first wave of health tech tools as it pushes data sharing initiative Read More »
The company disclosed that it expects a material impact on first-quarter financial results. However, it does not expect an effect on full-year results.
A Louisiana court on April 7 asked the FDA to complete its internal review of mifepristone’s safety and gave the agency six months to provide the court with an update on the investigation.
FDA probes abortion pill anew after court keeps mail access alive Read More »
Novo Nordisk’s oral Wegovy has a few months’ head start on Eli Lilly’s newly approved pill. While the Indianapolis pharma has come from behind the Danish rival in the weight loss space before, last time it clearly had the better drug.
With oral obesity race underway, all eyes are on Lilly’s Foundayo launch Read More »
In the future of AI-driven biopharma, reusable data is the most undervalued asset.
For AI To Have Impact, the Industry Must Align on Data Read More »
