Formulary Watch |

FDA Extends Mirena IUD for Eight Years of Use

Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.

Vizient Predicts Modest Drug Inflation in 2023

FDA to Review NDA for Nonhormonal Therapy for Menopause

If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.

Sanofi Stops Development of Amcenestrant

FDA Approves High Concentration Hadlima

Hadlima, a biosimilar of Humira, will be launched next year to treat patients with certain chronic autoimmune diseases.

FDA Approves Gene Therapy for Blood Disease

Counterfeit Drugs Remain a Significant Challenge

Analysis: 2022 Drug Launches Feature Record High Prices

Tris Pharma Launches Dyanavel XR Tablets for ADHD

A clinical trial showed Dyanavel XR tablets were bioequivalent to the extended-release oral suspension formulation of Dyanavel.

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.