FDA News

Amneal Pharmaceuticals launched mesalamine 800 mg delayed-release tablets for UC and received FDA approval for various lenalidomide doses for blood cancers.

Pitolisant was evaluated for the supplemental indication in the phase 3 INTUNE study, which did not meet its primary outcome of reducing excessive daytime sleepiness.

Chemomab completed an end-of-phase 2 meeting with the FDA and has aligned on the design of a phase 3 registration study for nebokitug (CM-101) in PSC.

Alvotech and Teva expect the review to be completed in the fourth quarter of 2025.

The FDA decision to approve the supplemental biologics license application for dupilumab (Dupixent) follows recent pivotal clinical trial data assessing 106 patients.

Targeted Genomics’ GHR test uses NGS to detect genetic variants in genomic DNA isolated from at-home collected saliva samples.

An audio recap of the top 5 stories in healthcare news from the week of 02/09-02/16.

Our top 5 headlines include a target date for a cholesterol-lowering drug, long-term dermatology data, and an expanded dosing label for geographic atrophy.

On February 14, 2025, the FDA approved the first rapid-acting biosimilar insulin product called nsulin-aspart-szjj (Merilog).

This approval by the FDA of Evolus’s 2 new hyaluronic acid gels provides an additional set of options for dermatologists in the aesthetic products market.

The FDA approved an expanded label for avacincaptad pegol, removing limitations on the duration of dosing beyond 12 months.

An approval for sparsentan in focal segmental glomerulosclerosis would mark the second rare kidney disease approval for the agent.

The drug given this designation, known as rezpegaldesleukin, is indicated for adult and pediatric patients aged 12 years and older with atopic dermatitis.

Announced by LIB Therapeutics Inc., the agency has set a PDUFA target action date of December 12, 2025.

This announcement by INmune Bio, Inc., follows positive findings in the MissionEB clinical trial evaluating CORDStrom for treatment of recessive dystrophic epidermolysis bullosa.

The Fast Track Designation was granted to Biodexa Pharmaceuticals’ eRapa based on phase 2 data showing its safety and tolerability in adults with FAP.

Our top 5 headlines include a trial of gene-edited pig kidneys, a first-of-its-kind antibiotic approval, and new guidelines for migraine.

Emblaveo combines aztreonam, a monobactam antibiotic, and avibactam, a β-lactamase inhibitor.

Brensocatib, also a potential first-in-class DPP1 inhibitor, has a PDUFA date of August 12, 2025.

Golimumab, marketed under the names Simponi and Simponi Aria, is approved for RA, PsA, AS, and UC.

ADI-001 now has FDA Fast Track Designation for relapsed/refractory lupus nephritis and systemic lupus erythematosus with extrarenal involvement.

The FDA’s approval marks the second indication for Genentech's refillable ocular implant in addition to wet age-related macular degeneration.

Tocilizumab-anoh will be available in both intravenous and subcutaneous formulations.

Our top 5 headlines include approvals for a non-opioid pain reliever, the latest indication for semaglutide, positive phase 2 data in MASH, and more.

This FDA News Month in Review provides a round-up of regulatory decisions and submissions from January 2025.

The FDA approval of suzetrigine, a non-opioid pain signal inhibitor, may help address the needs of patients with moderate-to-severe acute pain.

Axsome Therapeutics announced that the FDA approved the NDA for AXS-07 to treat acute migraine with or without aura on January 30, 2025.

Awarded to Roche, the Tina-quant® Lipoprotein (a) Gen.2 Molarity assay will be the first 510(k) cleared test measuring Lp(a) in nanomoles per liter (nmol/L).

The FDA approved semaglutide to reduce the risk of kidney disease worsening, kidney failure, and death due to CVD in those with T2D and CKD.

The regulatory agency has assigned a Prescription Drug User Fee Act (PDUFA) target action date of September 14, 2025.