Citing a court order for its haste, the U.S. FDA skipped the draft and went straight to issuing a final guidance that will change how certain ophthalmic drugs are regulated.
The U.S. biosimilar review process seems to be hitting its stride, with the FDA approving, in the first cycle, 67%, or 14, of the 21 biosimilar applications filed and acted upon in the first four years of BsUFA II.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aura, Biomarin, BMS, Kye, Neurosense, Oryzon, Provention, Travere.
If the U.S. SEC adopts a rule it proposed March 21, all public companies registered with the regulator, including biopharma and med-tech firms, will have to add disclosures about climate change to their other reporting obligations.
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Bristol Myers Squibb Co.’s relatlimab will hit the market as the first U.S. FDA-approved LAG-3 inhibitor, cleared by the agency for use in a fixed-dose combination with Opdivo (nivolumab) to treat adult and pediatric patients with unresectable or metastatic melanoma. The approval, a day ahead of the March 19 FDA target date, adds another type of immune checkpoint inhibitor to the oncology arsenal, which already includes drugs targeting PD-1/PD-L1 and CTLA4.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Astrazeneca, Cstone, Kiora, Moderna, Sobi.
Marinus Pharmaceuticals Inc.’s GABAA receptor agonist Ztalmy (ganaxolone), has won U.S. FDA approval for treating seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder.
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Abbvie, Amolyt, Aquestive, Bioheng, Heron, Inflarx, Moderna, TC, Tetra.
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