Politics and Policy

The FDA had previously issued a CRL due to manufacturing issues for the therapy, which is seeking an indication for preventing infections after chemotherapy for breast cancer. The agency has set a new PDUFA date of September 9, 2022.

Igalmi is the first and only film that dissolves under the tongue that treats adults with agitation associated with schizophrenia or bipolar. BioXcel expects to launch the therapy in the second quarter of 2022.

Novartis’ Vijoice is the first approved treatment for PIK3CA-related overgrowth spectrum, a group of rare disorders.

Illuccix is approved to detect prostate cancer when using PET scan. It is available through Cardinal Health, PharmaLogic, and United Pharmacy Partners.

A phase 3 trial is expected to begin by the end of the second quarter.

The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.

Genentech also announced progress in meeting the supply challenges associated with Actemra, which is currently available under an emergency use authorization.

The FDA has asked Merck to provide to additional data from studies. The new PDUFA date is July 1, 2022.

The FDA’s final decision on AMX0035 is expected by June 29, 2022

The FDA cited safety concerns related to vadadustat, which is under review for the treatment of anemia due to chronic kidney disease.

The FDA is asking for nearly a 34% increase over the agency's fiscal year 2022 funding level.

The long-acting HIV medication is now available for those 12 years and older living with HIV-1.

Antares Pharma plans to launch Tlando, which doesn’t require dose titration, in the second quarter of 2022.

The FDA determined that the benefits of the second booster dose outweighed the risks after reviewing data from Pfizer, BioNTech, and Moderna.

Ozempic is now available in three doses to improve blood sugar in people with type 2 diabetes.

The FDA has okayed allowing patients to start treatment with the injection instead of having a lead in with the oral version.

Fintepla was approved to treat Lennox-Gastaut syndrome, which first appears in childhood and can affect neurodevelopmental, cognitive, and motor functions.

Reblozyl is being reviewed to treat anemia in patients with beta thalassemia. The new date is June 27, 2022.

Pluvicto is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.

The FDA has asked for an additional clinical trial with overall survival as the endpoint.

The CRL delays the commercial return in the United States, Takeda didn’t release any information about the reason for the CRL.

The FDA also approved a companion diagnostic to select patients with mismatch repair deficiency who would be eligible for treatment with Keytruda.

Opdualag is a first-in-class immunotherapy that combines Opdivio with the novel LAG-3-blocking antibody relatlimab.

Teplizumab is being evaluated to delay type 1 diabetes. The PDUFA date is August 17, 2022.

Ztalmy was approved for seizures associated with CDKL5 deficiency disorder in patients two years of age and older. It is expected to be available in July 2022.

Amneal is of 35 global companies selected to manufacture and commercialize generic version of COVID-19 treatment Paxlovid.

This approval is the first indication for Rinvoq in gastroenterology.

Called Breyna, this drug-device combination generic product is a metered-dose inhaler, which contains both budesonide and formoterol.

After a phase 3 trial showed that Cabometyx/atezolizumab did not improve overall survival in patients with hepatocellular carcinoma, Exelixis officials have said they won’t be submitting an NDA for untreated patients with advanced liver cancer.

The FDA has asked for clinical data for Fasenra, which is being reviewed as a treatment for chronic rhinosinusitis with nasal polyps.