NEW RELEASES

NEW RELEASES :- Pharmatimes

Vista trial begins dosing in precision cancer vaccine study July 30, 2026
First-in-human evaluation of infinitopes’ therapeutic platform
John Pinching
Lynavoy recommended for EU approval by the CHMP July 30, 2026
First IBAT inhibitor for PBC cholestatic pruritus
John Pinching
Atsena gains EMA orphan status for two gene therapies July 29, 2026
Designation supports pivotal trials for emerging candidates
John Pinching
J&J reports major survival gains with dual‑target myeloma regimen July 29, 2026
Phase 3 data show strong benefit for two therapies
John Pinching
OrbusNeich begins Japanese trial for drug‑coated balloon July 28, 2026
First patient enrolled in pivotal coronary study
John Pinching
Nezglyal receives positive CHMP opinion supporting treatment access for boys with cALD July 28, 2026
European regulators move closer to approving option for young male patients
John Pinching
Novogene Europe expands single‑cell sequencing capability in Cambridge July 27, 2026
New service strengthens UK access to advanced multiomics support
John Pinching
MAD World Summit 2026 July 27, 2026
Where the future of workplace wellbeing takes centre stage
John Pinching
GSK wins US approval for ROS1 lung cancer therapy July 23, 2026
Jideytro offers option for previously treated patients
John Pinching
Lundbeck secures FDA Fast Track for narcolepsy drug July 23, 2026
Designation supports development of novel orexin therapy
John Pinching

NEW RELEASES :- Pharma Voice

Why pharma’s record-setting M&A streak is so unique July 31, 2026
Early-stage candidates, mid-sized companies and of course, Chinese assets, are dominating the dealmaking picture this year.
Kelly Bilodeau
Genetic clues for cell therapy toxicities; Summit’s high-stakes FDA decision July 31, 2026
Researchers have pinpointed genes linked to dangerous CAR-T cell therapy side effects, and a predictions market weighs in on Summit’s closely-watched cancer drug.
PharmaVoice Staff
How Telix landed a $2.1 billion radiopharma deal with Regeneron July 30, 2026
Regeneron tapped the Aussie biotech to enter the radiopharma market with a multi-pronged agreement.
Alexandra Pecci
BMS and Gilead rule in the CAR-T space. Off-the-shelf developers aren’t trying to change that. July 29, 2026
Rather than going head-to-head with approved CAR-T cell therapies, biotechs like Caribou Biosciences are positioning their drugs to fill unique market gaps.
Kelly Bilodeau
Kalshi is expanding online betting in drug R&D — unless detractors can stop it July 28, 2026
Kalshi sees drug development predictions as a way to improve R&D transparency. Critics say they could create financial incentives around research and undermine public trust.
Susanna Vogel
Brand-name drug denials are surging, especially for weight-loss July 28, 2026
Nearly one-third of prescriptions included in a new study were rejected the first time a patient attempted to fill them.
Alexandra Pecci
Why 3 secretive biotechs are keeping their science close to the chest July 27, 2026
Startups like Altos Labs are keeping pipeline details scarce to protect their ideas from competitors — but some experts say stealth only works for biotechs with deep pockets.
Kelly Bilodeau
The FDA was all in on AI. Will that change? July 24, 2026
High-level turnover has introduced uncertainty about how quickly the FDA’s agency-wide AI strategy will move forward.
Kelly Bilodeau
Lilly’s leap into psychedelics; peptides in the spotlight July 24, 2026
Eli Lilly is extending its push in neuroscience while the FDA wrestles with controversial peptide drugs.
PharmaVoice Staff
What’s in the FDA’s latest batch of rejection letters July 23, 2026
A look at two recent CRLs demonstrate the tension and discrepancies between how companies and the agency communicate drug rejections.
Alexandra Pecci

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Vista trial begins dosing in precision cancer vaccine study
First-in-human evaluation of infinitopes’ therapeutic platform
Lynavoy recommended for EU approval by the CHMP
First IBAT inhibitor for PBC cholestatic pruritus
Atsena gains EMA orphan status for two gene therapies
Designation supports pivotal trials for emerging candidates
J&J reports major survival gains with dual‑target myeloma regimen
Phase 3 data show strong benefit for two therapies
OrbusNeich begins Japanese trial for drug‑coated balloon
First patient enrolled in pivotal coronary study
Nezglyal receives positive CHMP opinion supporting treatment access for boys with cALD
European regulators move closer to approving option for young male patients
Novogene Europe expands single‑cell sequencing capability in Cambridge
New service strengthens UK access to advanced multiomics support
MAD World Summit 2026
Where the future of workplace wellbeing takes centre stage
GSK wins US approval for ROS1 lung cancer therapy
Jideytro offers option for previously treated patients
Lundbeck secures FDA Fast Track for narcolepsy drug
Designation supports development of novel orexin therapy

GMP and Quality

Non-conformances in Pharmaceutical Laboratories

Pharma VedMay 8, 2024

Pharmaceutical quality control laboratories are the guardians of public health. Through meticulous testing of raw materials, in-process materials, and finished products, they ensure the safety and efficacy of medications. However, nonconformances can arise...