Pharmaceutical Technology on MSN

Arrowhead nets first commercial win as siRNA drug garners FDA approval

Redemplo’s approval in familial chylomicronemia syndrome places the drug in competition with Ionis’ Tryngolza.
Fierce Pharma

FDA takes issue with AstraZeneca TV ad, citing 'misleading impression' of Farxiga indications

Following the FDA’s September announcement of a crackdown on direct-to | Monday, the FDA’s Office of Prescription Drug ...
Fierce Pharma

Arrowhead strikes true with 1st FDA approval, but Ionis competition looms

With a fresh FDA endorsement for its drug plozasiran, California-based Arrowhead Pharmaceuticals has successfully broken ...
BioPharma Dive

RNAi biotech Arrowhead wins first FDA approval

The clearance of Redemplo for a rare genetic disorder marks Arrowhead’s transition, after two decades, into a ...

Merck sees over $5 billion opportunity in Cidara's experimental flu drug

Merck said on Monday it expects a commercial opportunity exceeding $5 billion from Cidara Therapeutics' experimental flu drug ...
MassDevice

Stereotaxis gets FDA nod for next-gen GenesisX surgical robot

Stereotaxis announced today that it received FDA 510(k) clearance for its next-generation GenesisX surgical robot.
PharmExec

How the FDA Commissioner’s National Priority Vouchers Reshape Manufacturing, Pricing & Global Strategy

The FDA’s new Commissioner’s National Priority Voucher signals a transformative shift in U.S. drug review, tying accelerated approval to manufacturing readiness, domestic supply-chain strength, and ...
BioSpace

Drugmakers Push FDA To Extend Support to Existing Facilities

Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of ...

Merck expects over $5 billion commercial opportunity from Cidara's flu drug

Merck said on Monday it expects a non-risk adjusted commercial opportunity in excess of $5 billion from Cidara Therapeutics' ...