Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...

Zevra Therapeutics Inc (ZVRA) reports significant progress with Myle's launch and strategic planning, despite financial ...

PharmaTher Holdings Ltd. (the “Company” or “PharmaTher”) (OTCQB: PHRRF) (CSE: PHRM), a specialty pharmaceutical company, today announced that the Company requested a post-complete letter clarification ...

Serge Belanger’s rating is based on a clear path toward FDA approval and the subsequent launch of Yutrepia ... adds confidence to the anticipated approval timeline, potentially even accelerating it by ...

Received tentative approval from the FDA for YUTREPIATM (treprostinil) inhalation powder for both pulmonary arterial hypertension (PAH) ...

The meeting, scheduled on November 19, 2024 evening at the Central Drugs Standard Control Organisation (CDSCO), FDA Bhawan, New Delhi ... Besides, delays in the regulatory approval process can also ...

In November 2024 we received FDA Breakthrough Device Designation for the SCD for use in chronic dialysis, our first such designation for a chronic indication. This is our fourth FDA award of ...

Oncolytics Biotech Inc (ONCY) showcases promising clinical progress and improved cash management amidst ongoing financial challenges.

Number three, gaining FDA approval for the Allurion Balloon and preparing for ... We’re not providing any sort of timeline at this point about when the product would get back on the market in France ...

Despite a net loss, WAVE Life Sciences Ltd (WVE) showcases promising clinical progress and a strengthened financial position ...

This era was characterized by data storage limitations and challenges in retrieval and analysis that adversely affected the ...

Ladies and gentlemen, thank you for joining us today. Welcome to Compugen's Third Quarter 2024 Results Conference Call. At ...