Last edition
News about Quality / GMP
Gland Pharma Receives US FDA Approval for Generic Sugammadex Injection
Gland Pharma has secured US FDA approval for its generic Sugammadex Injection and launched the product in the US, strengthening its injectable portfolio in a market valued at approximately USD 1.6 billion annually.
Quality / GMP | 29/07/2026 | By News Bureau | 132
Lundbeck's Oral Narcolepsy Drug Candidate Receives FDA Fast Track Designation
Lundbeck has received FDA Fast Track designation for Lu AH69593, its investigational oral orexin 2 receptor agonist, accelerating the development of a potential new treatment for patients living with narcolepsy.
Quality / GMP | 27/07/2026 | By News Bureau
PD-L1 IHC 22C3 pharmDx gains CE-marked indication to identify eligible patients with epithelial ovarian, fallopian tube and primary peritoneal carcinoma for pembrolizumab treatment.
Quality / GMP | 27/07/2026 | By News Bureau
EU Approves AstraZeneca's Etcamah Combination for ESR1-Mutated Advanced Breast Cancer
The European Commission has approved AstraZeneca’s Etcamah in combination with CDK4/6 inhibitors for ESR1-mutated ER-positive, HER2-negative advanced breast cancer, following Phase 3 data demonstrating a 56% reduction in the risk of disease progression or death.
Quality / GMP | 24/07/2026 | By News Bureau | 139
FDA Grants Priority Review to Pfizer's Talzenna-Xtandi Combination Advanced Prostate Cancer
Pfizer’s Talzenna-Xtandi combination receives FDA Priority Review for HRR gene-altered metastatic castration-sensitive prostate cancer, with Phase 3 data demonstrating a 52 percent reduction in the risk of disease progression or death.
Quality / GMP | 24/07/2026 | By News Bureau | 168
Chiesi Secures UK Approval for World's First Low-Carbon pMDIs Using Next-Generation Propellant
MHRA authorises Clenil Modulite inhalers with a non-PFAS, low global warming potential propellant, reducing carbon emissions by up to 90 percent while maintaining therapeutic efficacy.
Quality / GMP | 23/07/2026 | By News Bureau | 116
JCR Pharmaceuticals secures its first international approval for Izcargo in the UAE, expanding access to its innovative blood-brain barrier-penetrating therapy for patients with Hunter syndrome and advancing rare disease treatment across the MENA region.
Quality / GMP | 23/07/2026 | By News Bureau | 188
Dyne Therapeutics' Duchenne Muscular Dystrophy Therapy Receives FDA Priority Review
FDA accepts Biologics License Application for investigational exon 51-skipping therapy z-rostudirsen, with a regulatory decision expected by January 2027.
Quality / GMP | 22/07/2026 | By News Bureau | 132
CuraTeQ Biologics Secures ANVISA Approval for Hyderabad Biosimilars Manufacturing Facility
CuraTeQ Biologics has received ANVISA GMP approval for its Hyderabad biosimilars manufacturing facility, strengthening its global regulatory credentials and enabling expanded supply of biosimilar products to Brazil and the wider Latin American market.
Quality / GMP | 22/07/2026 | By News Bureau | 224
Can-Fite BioPharma Secures Australian Patent for Namodenoson in Advanced Metastatic Cancer
Can-Fite BioPharma has secured an Australian patent covering the use of Namodenoson for advanced metastatic cancer, strengthening intellectual property protection as the drug advances through late-stage clinical development for liver and pancreatic cancers.
Quality / GMP | 15/07/2026 | By News Bureau | 134
We use our own and third party cookies to produce statistical information and show you personalized advertising by analyzing your browsing, according to our COOKIES POLICY. If you continue visiting our Site, you accept its use.
More information: Privacy Policy