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The FDA has granted accelerated approval to Vyondys 53 for the treatment of patients with Duchenne muscular dystrophy containing a mutation of the dystrophin gene that is amenable to exon 53 skipping.
Marketing authorisation has been granted by the EC for Evenity® (romosozumab) to treat osteoporosis in postmenopausal women.
A new study could aid pharmaceutical companies in their drug development efforts after if found that a drug candidate is more likely to be approved for use if it targets a gene known to be linked to the disease.
Sanofi has announced it is to acquire Synthorx to bolster its immuno-oncology pipeline for $2.5 billion.
The House of Representatives has voted to approve Speaker Pelosi’s drug pricing bill in a Democrat-led chamber, say reports.
In a new study, COMP360 (psilocybin) was well tolerated in healthy volunteers which support further investigation of a simultaneous 1:1 therapeutic administration design.
A new report has been published which draws on expertise from within and beyond the pharmaceutical industry to make recommendations for pharma communicators.
Alkermes, Inc. have received the warning letter after a promotional material review found it failed to adequately represent the risks of using the drug Vivitrol for patients with opioid use disorder.
The newly signed deal between the US, Mexico and Canada will hold down the price of biologic drugs in the continent, according to a report.
The European Commission has approved the label extension for KALYDECO® (ivacaftor) to include the treatment of infants with cystic fibrosis between six and 12 months old.
The FDA has informed consumers not to use drugs recalled from Basic Reset and Biogenyx following consent decree for federal violations.
Driven by the launch of various pipeline agents, a new report has projected that the multiple sclerosis therapeutics market will reach $32.9 billion in 2028.
Development of infrared light-sensitive microcapsules could be the future in targeted drug delivery for cancer treatment, says new research.
A survey has shown that the pharmaceutical industry believes R&D will see a lot of benefit from digital transformation and that AI will be at the forefront of this.
The EMA has announced that metformin tablets from outside the EU do not contain unacceptable levels of NDMA impurities and EU metformin is not affected.
