US FDA rejects AstraZeneca's easy-to-use version of lupus drug Saphnelo

Feb 3 (Reuters) - AstraZeneca said on Tuesday the U.S. health regulator has rejected its application for a self-injectable ...

US FDA rejects AstraZeneca's easier-to-use version of lupus therapy

Feb 3 (Reuters) - AstraZeneca said on Tuesday that the U.S. health regulator had rejected its application for an ...
Becker's Hospital Review

FDA delays approval for anaphylaxis drug

The FDA has delayed approval of Aquestive Therapeutics’ new drug application seeking approval of Anaphylm, a sublingual epinephrine film for the treatment of Type 1 allergic reactions, including ...
Fierce Biotech

FDA outlines draft policy on MRD, complete response for accelerated approvals in multiple myeloma

After a short delay and concerns of potential intervention from senior officials, the FDA has issued a draft guidance for the industry on the potential use of minimal residual disease (MRD) and ...
Fierce Healthcare

The Trump administration is creating clinical AI agents with a 3-year FDA approval timeline

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals to develop two agentic AI assistants for ...
The Manila Times

SCIENTURE Provides Commercial Update on ARBLI™, the First FDA-Approved Ready-to-Use Oral Suspension of Losartan Potassium

Company highlights accelerating access and revenue growth for ARBLI™ and confirms REZENOPY™ launch timeline, addressing a combined US annual losartan and naloxone market size of close to $385 million ...
Targeted Oncology

FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual ...