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Novartis subsidiary Sandoz is suing the FDA over the new chemical entity (NCE) exclusivity it granted Sanofi’s multiple sclerosis drug Aubagio (teriflunomide), alleging the five-year protection it gave was unlawful and wrongly kept Sandoz’s generic teriflunomide from being reviewed by the agency. Read More
San Diego, Calif.-based Acadia Pharmaceuticals has received a notification of deficiencies from the FDA regarding its supplemental New Drug Application (sNDA) for Nuplazid (pimavanserin), an anti-psychosis drug being reviewed for treating dementia-related hallucinations and delusions. Read More
The FDA’s Oncology Center for Excellence is scrutinizing Accelerated Approvals granted for cancer indications in an initiative that’s led to multiple indication withdrawals by companies whose late-stage trials failed to meet primary endpoints. Read More
The Pfizer/BioNTech COVID-19 vaccine demonstrated effectiveness against a Brazilian coronavirus strain that has quickly spread throughout the country, a study has found. Read More
Gilead Sciences’ daily oral HIV blockbuster Biktarvy has shown success as a long-term treatment, demonstrating continued high efficacy and strong viral suppression in two phase 3 trials that conducted years of follow-up. Read More
The European Commission (EC) will kick off a new pilot program later this month to collect information from drug sponsors to better understand why oncology and orphan drug products may be unevenly marketed across the 27-member bloc. Read More