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Si­mul­ta­ne­ous ad­vice from FDA and EMA? Very few com­pa­nies go that route with new drugs, re­view finds

3 years ago
FDA+

Man­u­fac­tur­ing roundup: Gen­Sight ter­mi­nates batch of gene ther­a­py; Evonik opens lipid pro­duc­tion site in Ger­many

3 years ago
Manufacturing

Apo­tex is­sues re­call of eye treat­ment over cracked bot­tle caps

3 years ago
Pharma
FDA+

San­doz to ex­pand its pres­ence in Slove­nia with new $400M plant

3 years ago
Manufacturing

UMass med­ical school’s man­u­fac­tur­ing unit lays off 26 em­ploy­ees

3 years ago
People
Manufacturing

As­traZeneca touts PhI­II event-free sur­vival win with Imfinzi

3 years ago
R&D

Co­herus Bio­Sciences lays off 20% of staff, while an­timi­cro­bial biotech makes deep­er cuts

3 years ago
People

Ne­oleukin sends 70% of staff pack­ing as IL-2 biotech search­es for sale or oth­er ex­it

3 years ago
People

Fresh Tracks con­sid­ers op­tions to stay afloat and de­vel­op au­toim­mune can­di­dates

3 years ago
R&D

Flag­ship biotech 'Rings' in $85M+ for next-gen gene ther­a­py ef­fort

3 years ago
Financing
Cell/Gene Tx

Tagris­so reach­es OS end­point in PhI­II EGFR-mu­tat­ed lung can­cer tri­al

3 years ago
R&D

Ten years lat­er, Lil­ly's long-term Alzheimer's tri­al of solanezum­ab has de­fin­i­tive­ly failed

3 years ago
R&D
Pharma

Short sup­ply of com­mon­ly used can­cer drugs rais­es con­cerns among hos­pi­tal phar­ma­cists

3 years ago
Pharma
Manufacturing

ALS biotech QurAlis gets $88M boost from four phar­mas for pair of PhI stud­ies

3 years ago
Financing
Startups

In­dus­try ad­vo­cates urge Sen­ate health com­mit­tee lead­ers to sup­port an­timi­cro­bial pric­ing re­form

3 years ago
Pharma

FDA rais­es ques­tions in ad­comm brief­ing docs for Roche's Po­livy la­bel ex­pan­sion

3 years ago
Pharma
FDA+

Organon dou­bles down on mis­sion to pre­vent un­planned preg­nan­cies with $30M in­vest­ment

3 years ago
Pharma
Marketing

An eye, 15 sec­onds and strik­ing an­i­ma­tion: How Hori­zon's thy­roid eye dis­ease cam­paign hit home with pa­tients

3 years ago
R&D

No­var­tis CEO takes pay cut as Ab­b­Vie's Rick Gon­za­lez nabs near­ly 10% raise

3 years ago
Pharma

FDA in­spec­tion un­cov­ers cher­ry-col­ored an­tibi­ot­ic residue on equip­ment at Teva's New Jer­sey site

3 years ago
FDA+
Manufacturing

FDA says no ad­comm planned for Bio­gen, Sage's de­pres­sion drug

3 years ago
FDA+

Bio­Marin seeks la­bel ex­pan­sion for achon­dropla­sia drug; FDA lifts In­hibikase full clin­i­cal hold

3 years ago
News Briefing

Mesoblast’s aGVHD cell ther­a­py will get an­oth­er shot at the FDA

3 years ago
FDA+

Ex-NIH, Sanofi lead­ers nab Mer­ck sup­port for their biotech’s Ep­stein-Barr vac­cine 

3 years ago
Deals
Pharma
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