Abolish the FDA (opinion)
Many seriously ill people die waiting for the FDA to approve drugs that regulators in other advanced countries have already ...
Aldeyra's FDA Resubmission And AbbVie Option Revitalize Reproxalap's Prospects
Aldeyra received an FDA CRL for reproxalap, necessitating an additional study for DED approval. Read why I continue to rate ...
Reuters13h
US FDA approves PTC Therapeutics' gene therapy for ultra-rare disorder
PTC Therapeutics' gene therapy is already approved in the European Union, Great Britain, and Israel. The drugmaker will also ...
SF Weekly13h
Leen Kawas Details the Factors Behind High Drug Development Costs (and Presents Strategies to Address Them)
She also offered strategies to streamline the process and reduce the strain on the developer ... the drug developer submits ...
News Medical14h
The benefits and challenges of FDA Fast-Track and Accelerated Approval in drug development
Expediting the review process allows for appropriately timed advice and implementing adjustments that considerably reduce the ...
FDA approves Emrosi for rosacea in adults
The U.S. Food and Drug Administration has approved Journey Medical's Emrosi (minocycline hydrochloride) for the treatment of ...
ProKidney’s Progress in FDA Approval and Financial Health
Prokidney Corp. ( (PROK) ) has released its Q3 earnings. Here is a breakdown of the information Prokidney Corp. presented to its investors.
US FDA declines full approval for Intercept's liver disease drug
By Bhanvi Satija and Puyaan Singh (Reuters) - The U.S. Food and Drug Administration on Tuesday declined full approval for ...