Eye-fo­cused Iver­ic Bio re­ports pos­i­tive PhI­II read­out as shares surge, FDA fil­ing planned

3 years ago
R&D

FDA's out­side ex­perts to re­view GSK, As­traZeneca drugs; Biotech gives very ear­ly pos­i­tive in­di­ca­tions for cell ...

3 years ago
News Briefing

Up­dat­ed: Athi­ra plots an Alzheimer's come­back af­ter scan­dal, PhII fail — and hints at pos­si­ble ac­cel­er­at­ed ...

3 years ago
R&D
FDA+

Covid-19 roundup: CanSi­no’s in­haled vac­cine gets thumbs-up from Chi­nese reg­u­la­tors; Sino­vac gets go-ahead for ...

3 years ago
Coronavirus

On fi­nal dash to the clin­ic, Ar­se­nal­Bio hauls in $220M for 'mod­u­lar' cell ther­a­py ap­proach

3 years ago
Financing
Cell/Gene Tx

#ES­MO22: Dizal touts win in niche NSCLC pop­u­la­tion cor­nered by Take­da, J&J

3 years ago
R&D
China

Af­ter se­ri­ous side ef­fect, Sarep­ta and FDA re­align on next-gen Duchenne drug with tri­al hold lift­ed

3 years ago
FDA+

Alvotech fails pre-ap­proval in­spec­tion for its pro­posed Hu­mi­ra in­ter­change­able biosim­i­lar

3 years ago
Pharma
FDA+

Up­dat­ed: EU swats down Il­lu­mi­na's $8B Grail ac­qui­si­tion days af­ter FTC lost an­titrust case

3 years ago
Deals
Pharma

Seek­ing first-in-class glo­ry, Roche en­lists biotech part­ner that prides it­self on crack­ing 'un­drug­gable' tar­gets

3 years ago
Deals

Lat­est news on FDA’s sec­ond look at Amy­lyx; Un­pack­ing Parkin­son’s R&D; Fiona Mar­shall takes over NI­BR from Jay ...

3 years ago
Weekly

FDA again finds Amy­lyx's ALS da­ta lack­ing ahead of un­usu­al sec­ond ad­comm, while stress­ing dire need for treat­ments

3 years ago
Pharma
FDA+

FDA ex­pands ap­proval for Ver­tex's CF drug Orkam­bi to in­fants un­der two years of age

3 years ago
Pharma
FDA+

Biosim­i­lar gi­ant Bio­con gets hit with 483 for is­sues at sites in Malaysia and In­dia

3 years ago
FDA+
Manufacturing

Lead­ing health­care agency notch­es dou­ble-dig­it growth for first half, dri­ven by dig­i­tal shifts and full pipelines

3 years ago
Pharma
Marketing

Court win for Unit­ed Ther­a­peu­tics will re­strain loom­ing com­pe­ti­tion for its soon-to-be block­buster

3 years ago
Law

PhRMA and BIO seek changes in FDA’s guid­ance to mit­i­gate drug short­ages

3 years ago
R&D
Manufacturing

J&J coughs up $40.5M in New Hamp­shire opi­oid set­tle­ment, evad­ing up­com­ing tri­al

3 years ago
Law

Mer­ck spells out ac­cess, en­vi­ron­men­tal goals in lat­est ESG re­port

3 years ago
Pharma
Marketing

Two years af­ter a refuse-to-file, Y-mAbs lands an FDA ad­comm for its 2nd neu­rob­las­toma treat­ment

3 years ago
FDA+

Shang­hai-based cell ther­a­py biotech nabs new funds; Col­orado biotech nets an ac­qui­si­tion

3 years ago
Financing
China

French start­up Abi­vax rais­es $49M to cross the PhI­II fin­ish line for ul­cer­a­tive col­i­tis drug

3 years ago
Financing

Small Is­raeli biotech flops a PhI­II test in post-surgery in­fec­tions — shares crushed

3 years ago
R&D

Am­neal asks FDA to ap­prove an­oth­er new for­mu­la­tion of Parkin­son’s com­bo drug 

3 years ago
Pharma
FDA+
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