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 ...

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 ...
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 ...
Managed Healthcare Executive

FDA issues draft guidance on MRD and complete response as primary endpoints for accelerated multiple myeloma drug approvals

FDA proposes MRD-negative and complete response endpoints to fast-track multiple myeloma drug approvals, pushing deeper molecular results over ORR.
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 ...
Seeking Alpha

Taysha outlines accelerated BLA timeline for TSHA-102 with FDA Breakthrough Therapy designation and full global rights

Management reiterated plans to initiate the REVEAL pivotal trial for TSHA-102, with the first patient dosing scheduled for the current quarter and additional enrollment expected across multiple sites.
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FDA Issues Draft Guidance on MRD and CR End Points in Multiple Myeloma

The FDA released a draft guidance document that provides a regulatory framework for sponsors to utilize minimal residual disease (MRD) and complete response (CR) as primary end points in clinical ...