Lia DeGroot

In a com­men­tary pub­lished Thurs­day, sev­er­al top FDA of­fi­cials of­fered in­sight in­to a key ques­tion when it comes to con­duct­ing clin­i­cal tri­als: How should re­al-world

PTC Ther­a­peu­tics on Thurs­day an­nounced an agree­ment with Roy­al­ty Phar­ma to mon­e­tize up to $1.5 bil­lion of the roy­al­ty stream for the spinal mus­cu­lar at­ro­phy

Af­ter Sen­ate Health Com­mit­tee Chair Bernie Sanders ini­tial­ly held up the nom­i­na­tion process for Pres­i­dent Joe Biden’s pick to lead the Na­tion­al In­sti­tutes of Health

The US boast­ed faster re­view times for drug ap­pli­ca­tions over the past decade com­pared to those in the EU and Switzer­land, ac­cord­ing to a new

Bris­tol My­ers Squibb on Fri­day nabbed an­oth­er ap­proval for its block­buster can­cer treat­ment Op­di­vo. The drug was ap­proved to treat pa­tients ages 12 and old­er

HHS on Fri­day an­nounced its se­lec­tions for the next-gen­er­a­tion of Covid-19 vac­cine can­di­dates to re­ceive $500 mil­lion in fund­ing as part of the gov­ern­ment’s Project

Af­ter the FDA pub­lished draft guid­ance over the sum­mer on post­mar­ket­ing ap­proach­es to col­lect­ing da­ta from un­der­rep­re­sent­ed groups, stake­hold­er groups large­ly wel­comed the FDA’s pro­pos­als

On the heels of con­t­a­m­i­na­tion con­cerns, the FDA on Thurs­day pub­lished draft guid­ance on qual­i­ty con­sid­er­a­tions for top­i­cal eye treat­ments, di­rect­ing man­u­fac­tur­ers to eval­u­ate vis­i­ble

GSK is gear­ing up to dis­con­tin­ue the brand-name ver­sion of its asth­ma med­ica­tion Flovent, just as the Med­ic­aid re­bate cap is end­ing in Jan­u­ary 2024,

CMS did not make a na­tion­al cov­er­age de­ter­mi­na­tion for PrEP by the ex­pect­ed date of Oct. 10, but a fi­nal de­ci­sion will be com­ing lat­er,