Business, energy, technology, markets and global industry news from Business News Today

Skip to content

Home
Pharma & Biotech
Medical Devices & Diagnostics
Features & Analysis

Home
Pharma & Biotech
Medical Devices & Diagnostics
Features & Analysis

rese-cel

PharmaDeviceNews rese-cel

Cellares FDA PreCheck selection puts automated cell therapy manufacturing under early review

Pharma & Biotech

Cellares enters FDA PreCheck as Cell Shuttle moves from automation promise to regulatory proof

by Pallavi Madhiraju
July 1, 2026
0 Comments

Find out how Cellares’ FDA PreCheck selection could reshape automated cell therapy manufacturing while leaving product approval risks intact.

Read More

Latest news and features

Minoryx Therapeutics secures exceptional-circumstances CHMP recommendation for leriglitazone
Merck is licensing alimatravir before Phase 3 ends. Can a monthly HIV pill beat the access clock?
Gilead’s Trodelvy cleared a key EU hurdle, but can it really replace chemotherapy in first-line TNBC?
What the Apollo Hospitals and Precisio Biotix lysin partnership means for India’s AMR crisis
MannKind Corporation wins FDA approval for 10-second Furoscix ReadyFlow furosemide autoinjector
Roche’s new vaginitis PCR test is FDA-cleared, but the real commercial test starts inside laboratories
Why Par Health’s first generic Janumet XR launch could trigger a rapid U.S. pricing reset
Why Alcon and Aravind’s 60-trainee retina surgery hub could matter far beyond Coimbatore
Can NADclinic and GCLS turn longevity medicine’s training gap into a clinical standard?
Harbour BioMed’s revenue is climbing, but one profit number complicates the growth story
What Regenative Labs’ 117-patient ProText study reveals about chronic paraspinal degeneration
Lilac Biosciences and Soin Neuroscience publish RNA biomarker review for neuropathic pain

POPULAR NEWS

Niagen Bioscience’s NB4168 has secured U.S. FDA Rare Pediatric Disease and European orphan designations as the company advances the experimental ataxia telangiectasia therapy toward human trials. Representative image.

Pharma & Biotech

Niagen wins twin rare-disease designations, but can NB4168 turn nicotinamide riboside evidence into a medicine?

July 14, 2026

Representative image of biopharma laboratory research. Gilead Sciences and Merck’s latest Phase 3 updates highlight the promise of once-weekly HIV treatment with islatravir and lenacapavir, while raising fresh questions over Trodelvy’s lung cancer expansion strategy.

Pharma & Biotech

Gilead and Merck pipeline update reveals promise in HIV and pressure in oncology

June 9, 2026

Representative image of a clinician reviewing skeletal imaging, illustrating Mirum Pharmaceuticals and Incyte’s zilurgisertib Phase 2 progress in fibrodysplasia ossificans progressiva and the rare disease treatment questions facing regulators.

Pharma & Biotech

Why Mirum Pharmaceuticals and Incyte’s zilurgisertib data could reset expectations in FOP treatment

June 15, 2026

TAGS

biologics clinical trials Eli Lilly and Company European Medicines Agency FDA FDA approval immuno-oncology immunotherapy Inc. medical devices oncology precision oncology rare disease U.S. Food and Drug Administration United States Food and Drug Administration

About PharmaDeviceNews
Disclaimer
Editorial Policy
Privacy Policy
Contact Us

© 2026 PharmaDeviceNews.com. All rights reserved.