FDA+ channel feed

Rep­re­sen­ta­tives con­cerned over DSC­SA im­ple­men­ta­tion and sup­ply chain dis­rup­tion

Last year
Manufacturing

FDA ap­proves Tai­ho's Lon­surf with be­va­cizum­ab for metasta­t­ic col­orec­tal can­cer

Last year
Pharma

Com­mon can­cer drug man­u­fac­tur­er warned by the FDA over da­ta in In­dia

Last year
Pharma
Manufacturing

Ab­b­Vie, Lund­beck ask FDA to re­vise draft guid­ance on mi­graine drugs

Last year
Pharma

FDA and DEA call on AD­HD drug man­u­fac­tur­ers to up pro­duc­tion amid on­go­ing short­ages

Last year
Manufacturing

PDU­FA VII: Drug ap­pli­ca­tion fees in­crease by 25% in first year of new five-year deal

Last year

FDA looks to work with more out­side agen­cies for in­spec­tions as it en­ters in­to an agree­ment for in­spec­tions with Switzer­land

Last year
Pharma
Manufacturing

FDA ap­proves GSK's Jem­per­li for front­line use in cer­tain ad­vanced en­dome­tri­al can­cers

Last year

Re­pub­li­cans share draft bill to ad­dress drug short­ages

Last year
Pharma

As pres­sure mounts to take ac­tion on drug short­ages, law­mak­ers seek to boost pro­duc­tion in the US

Last year
Pharma
Manufacturing

Bio­haven’s tro­r­ilu­zole re­ject­ed be­fore FDA re­view

Last year

House, Sen­ate com­mit­tees mark up PBM bills as mo­men­tum for re­form mounts

Last year
Pharma

Oc­taphar­ma wins FDA ap­proval for drug to ur­gent­ly re­verse ef­fects of blood thin­ners

Last year
Pharma

Boehringer In­gel­heim, Eli Lil­ly's Jar­diance nabs ap­proval in Eu­rope for chron­ic kid­ney dis­ease

Last year
Pharma

Tar­sus scores first FDA ap­proval for treat­ment of red, itchy eyes caused by mites

Last year
Pharma

Lari­mar to kick off high­er dose of lead rare dis­ease drug, ini­ti­ate OLE tri­al

Last year
R&D

FDA ap­proves Ver­ri­ca's skin in­fec­tion treat­ment, en­ters in­to non-bind­ing term sheet for $125M loan

Last year
Pharma

CHMP rec­om­mends against Mi­rati's KRAS ri­val, in fa­vor of Pfiz­er's RSV vac­cine, oth­er drugs

Last year
Pharma

Emer­gent’s newest an­thrax vac­cine is now FDA-ap­proved

Last year

FDA ap­proves Dai­ichi Sanky­o's new first-line AML drug quizar­tinib with boxed warn­ing for heart dis­or­ders

Last year

Af­ter sev­en pa­tient deaths, ADC gets par­tial hold and de­cides to stop Zyn­lon­ta tri­al

Last year
R&D

Hori­zon adds 'se­vere hear­ing im­pair­men­t' warn­ing to block­buster's la­bel

Last year

FTC cau­tions against re­ly­ing on its past PBM ad­vo­ca­cy as in­dus­try push­es back

Last year
Pharma

De­spite Dem op­po­si­tion, House com­mit­tee ad­vances pan­dem­ic pre­pared­ness bill sans drug short­age pro­vi­sions

Last year
Pharma
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