Formulary Watch |

FDA Grants Priority Review to Lynparza/Abiraterone for Metastatic Prostate Cancer

The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.

FDA Accepts Polivy sBLA for Aggressive Blood Cancer

The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.

Arcutis Launches Steroid-Free Psoriasis Therapy Zoryve

Zoryve is a next-generation topical PDE4 inhibitor to treat adults and adolescents with plaque psoriasis.

Novavax Seeks EUA for COVID-19 Booster

If authorized, Novavax’s vaccine would be the first protein-based COVID-19 booster for adults.

Genentech Adds Warnings to Ocrevus Label

Webinar: Inflation Reduction Act Will Be Positive for Medicare

Amneal Launches Four Generics Products

The four drugs recently launched include a generic of Clindagel, which received a competitive generic therapy designation from the FDA, for acne and Vasostrict for low blood pressure.

Quantum Leap Stops Cyclosporine Arm of I-SPY COVID Trial

Investigation into additional agents to treat patients with COVID-19 through the I-SPY COVID Trial is ongoing.

FDA Approves Xofluza to Treat and Prevent Flu in Children

Xofluza is a single-dose, oral therapy and is now approved for children five years and older for both the treatment and prevention of influenza.

FDA Approves Enhertu for Metastatic Lung Cancer

Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.

FDA Issues EUA for Monkeypox Vaccine for Under 18; IV Treatment on the Way

FDA Schedules Advisory Meeting for Microbiota-based C. Diff Therapy

The Vaccines and Related Biological Products Advisory Committee will hold a meeting on Sept. 22, 2022, to discuss Ferring’s RBX2660, a microbiota-based live biotherapeutic.

FDA Assigns Priority Review for Elacestrant in Metastatic Breast Cancer

If approved, elacestrant would be the first oral selective estrogen receptor degrader (SERD) as a second- or third-line treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The PDUFA date is Feb. 17, 2023.

Novaliq Submits NDA for Dry Eye Treatment

Novaliq’s CyclASol uses a new technology that allows cyclosporine to be soluble without water or preservatives.

Long COVID-19 a Priority for Biden Administration, Drug Developers

FDA Extends Review of Omaveloxolone in Friedreich’s Ataxia

The updated PDUFA date is Feb. 28, 2023, and the planned advisory committee meeting is on hold pending review of NDA amendments.

FDA Approves Myfembree to Treat Endometriosis

The approval had been delayed as the regulatory agency reviewed data on Myfembree's impact on bone mineral density.

FTC’s PBM Investigation Could Lead to Unintended Consequences

CivicaScript Launches Generic Abiraterone

Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.

HHS Declares Monkeypox Emergency, Expands Vaccine Distribution

FDA Approves Additional Indication for Nubeqa

Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.

Senate Passes Bill that Caps Insulin at $35 for Medicare Beneficiaries

FDA Approves Tablet Form of Calquence

The tablet form has the same safety and efficacy as the capsule formulation and allows it to be administered with gastric-reducing therapies.

FDA Approves Enhertu for HER2 Low Breast Cancer

This is the first approved therapy targeted to patients with the HER2-low breast cancer subtype. Its approval comes four months ahead of its PDUFA action date.

FDA Schedules Second Advisory Committee Meeting for AMX0035 in ALS

The committee will meet on Sept. 7, 2022, to discuss additional analyses of data from the Amylyx’s clinical studies. The updated PDUFA goal date is Sept. 29, 2022.

FDA Issues Complete Response Letter for Nuplazid in Alzheimer’s Psychosis

FDA Accepts BLA for Biosimilar of Actemra

Fresenius Kabi expects to receive FDA approval for its tocilizumab biosimilar in 2023 and is seeking approval in both intravenous and subcutaneous administration.

Pfizer Discontinues Late-Stage Cardiomyopathy Trial

Results indicated the trial is unlikely to meet its primary endpoint, the change from baseline in the six-minute walk test at 24 weeks.

CDC Adds Diagnosis Code for Rare Primary Immunodeficiency

The new code, effective Oct. 1, 2022, allows APDS to be recognized as an distinct immunological disease.

Keytruda/Lenvima Combo Fails in Liver Cancer Trial

This is the second trial in less than a month studying Keytruda that failed to meet endpoints.