regulatory
GSK’s Blenrep Demonstrates Survival Advantage Over J&J’s Darzalex in Multiple Myeloma Treatment
GSK, Blenrep, Belantamab mafodotin, Multiple myeloma, DREAMM-7, DREAMM-8, Darzalex, Survival advantage, Regulatory challenges
Rapport Therapeutics Faces Regulatory Hurdles in Pain Treatment Trials
Rapport Therapeutics, pain treatment trials, regulatory challenges, RAP-219, clinical development
Dr. Reddy’s Recalls Over 300,000 Bottles of Thyroid Medication Due to Carcinogen Contamination
Dr. Reddy’s, thyroid drug recall, carcinogen contamination, pharmaceutical safety, FDA regulations
Lexicon’s Diabetes Drug Zynquista Faces FDA Scrutiny Again Ahead of Advisory Committee Meeting
Lexicon Pharmaceuticals, Zynquista, FDA, diabetes drug, advisory committee, regulatory challenges
Mitigating Risks in mRNA Manufacturing: Strategies for Smooth Transition from Preclinical to Clinical Stages
mRNA manufacturing, risk management, preclinical to clinical transition, quality control, regulatory compliance, raw material selection, process automation, analytical methods.
European Commission’s Reconsideration of Translarna’s Marketing Authorization: A Critical Turning Point for Duchenne Muscular Dystrophy Treatment
Translarna, Duchenne muscular dystrophy, European Commission, EMA, CHMP, conditional marketing authorization, drug approval, regulatory decisions
AstraZeneca’s Airsupra Asthma Trial Halted Early Due to Overwhelming Efficacy, Paving Way for Regulatory Submission
AstraZeneca, Airsupra, asthma treatment, clinical trial, overwhelming efficacy, regulatory submission
BIOSECURE Act: A Potential Game-Changer for Biopharma – Industry Implications and Future Directions
BIOSECURE Act, Biopharma industry, US-China relations, Biotechnology collaborations, Supply chain diversification, Regulatory compliance
Moderna Faces Second Consecutive Marketing Breach for Spikevax Vaccine
Moderna, Spikevax, Marketing Breach, COVID-19 Vaccine, Regulatory Compliance
Japanese Regulators Approve Medications from Amgen, Eli Lilly, Takeda, and Nxera
Japanese regulators, medication approvals, Amgen, Eli Lilly, Takeda, Nxera, pharmaceutical industry, regulatory updates