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Acceleron Breakthrough for Pulmonary Hypertension Drug

[ Price : $8.95]

FDA grants Acceleron Pharma a breakthrough therapy designation for sotatercept and its use in treating patients with pulmonary art...

Dynamic Stem Cell Marketing Unapproved Biologics

[ Price : $8.95]

FDA says Dynamic Stem Cell Therapy is marketing unapproved cellular products as treatments for many diseases and conditions.

Lannett Gets FDA Meeting on Proposed Insulin Biosimilar

[ Price : $8.95]

Lannett says FDA has granted it a 6/9 Biosimilar Biological Product Development Type 2 meeting to plan next steps for the clinical...

Roche NDA Review Extended on Spinal Disorder Drug

[ Price : $8.95]

FDA extends by three months its review of a Roche NDA for risdiplam and its use in treating spinal muscular atrophy.

Are FDA EUAs Now Wishful Thinking?

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Multiple former FDA officials question the wisdom of the agency granting an emergency use authorization for two malaria medicines ...

Pentax Paying $43 Million in Endoscope Case

[ Price : $8.95]

The Justice Department says Pentax Medical is paying $43 million to resolve criminal charges resulting from its decision not to us...

FDA Approves Cipla Generic Proventil HFA

[ Price : $8.95]

FDA approves Ciplas generic form of Proventil HFA metered-dose inhaler.

Covid-19 Serology Tests Important Focus: CDRH

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CDRH Office of In Vitro Diagnostics and Radiological Health director Timothy Stenzel discusses the growing importance of serology ...

Additional FMT Safety Protections Needed: FDA

[ Price : $8.95]

FDA says it recommends additional safety protections be used with fecal microbiota for transplantation.

Liquidia NDA for Inhaled Treprostinil Dry Powder

[ Price : $8.95]

FDA accepts for review a Liquidia Technologies 505(b)(2) NDA for LIQ861 (treprostinil) for treating pulmonary arterial hypertensio...