FDA
After receiving a letter directly from CBER Director Vinay Prasad, Moderna said the FDA had previously signed off on the use of a licensed flu vaccine as a comparator for a Phase 3 study of mRNA-1010.
FEATURED STORIES
The Senate failed to pass a massive spending bill on Thursday—which includes the rare pediatric PRV program but also funding for the Immigration and Customs Enforcement’s large-scale crackdown in Minnesota and other states.
Some 200 rare disease therapies are at risk of losing eligibility for a pediatric priority review voucher, a recent analysis by the Rare Disease Company Coalition shows. That could mean $4 billion in missed revenue for already cash-strapped biotechs.
Together with robust data-driven modeling, rethinking regulation and data use could push forward a notoriously challenging field.
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ION582 is uniquely formulated using RNA technology to provide relief to patients with Angelman syndrome, a rare disorder for which limited treatment options are available.
The House of Representatives voted on a bill that would give the U.S. Food and Drug Administration more power to ensure biopharma companies run large follow-up trials to confirm accelerated approvals.
The approval expands the rapidly growing number of indications for Dupixent, which is the first and only biologic medication with the FDA’s nod to treat atopic dermatitis from infancy to adulthood.
Shares of TG Therapeutics are falling fast in Wednesday trading after the U.S. Food and Drug Administration announced it was pulling approval of the cancer drug Ukoniq (umbralisib).
The long weekend saw BMS’s Opdivo, Novartis’s Kymriah and Roche’s Evrysdi win FDA approvals in new indications.
Pfizer announced the FDA has granted its combinatorial therapeutic ervogastat/clesacostat Fast Track Designation that is intended for the treatment of NASH with liver fibrosis.
Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.
Ocugen introduced NeoCart, which is designed to repair full-thickness lesions of the knee cartilage in adults, as a Phase III cell therapy platform technology.
The approval marks the first for EoE, a chronic, progressive type 2 inflammatory disease that damages the eosinophilic esophagitis and prevents it from working properly.
Sanofi, AstraZeneca, Avillion and Diadem recently announced clinical results, providing positive news for patients with multiple myeloma, asthma and Alzheimer’s disease.