FDA News

This approval is the first for an FLT3 inhibitor and it's specifically indicated for patients who have FLT3-ITD.

RiVive is the second nonprescription naloxone product approved by the FDA, signaling a proactive effort to increase accessibility and consumer availability of life-saving medication.

The FDA has announced Abiomed has initiated a recall of all left-sided Impella pumps, citing inadequate instructions for use as it pertains to precautions to take with patients who have undergone TAVR.

Granted to Tarsus Pharmaceuticals, the approval of lotilaner ophthalmic solution 0.25% marks the first-and-only FDA-approved therapeutic for Demodex blepharitis, a common eyelid disease.

The long-awaited approval for VP-102 makes this treatment the first available therapy for the pox virus-borne skin disease.

In his interview, Dr. Amin discusses his views on the FDA’s recent approval of ritlecitinib for the treatment of adolescent patients with alopecia areata.

Individuals seeking contraception will be able to access norgestrel without consulting a health care provider, reducing barriers to contraception access.

Announced by Tandem Diabetes Care on July 11, 2023, the Tandem Mobi insulin pump is billed as the world's smallest insulin pump, at less than half the size of the t:slim X2 pump and able to fit in a coin pocket.

To celebrate the first half of 2023, we are recapping the top FDA approvals through June 2023 from within the HCPLive Network of brands.

From a novel acne cream to a breakthrough depression drug, a half-dozen agent decisions are coming through in the coming 6 months.

Dr. Juliana Biondo discusses the exciting FDA approval of Roctavian and how it compares with other treatment options like Hemlibra.

Our June 2023 cardiology month in review includes 3 FDA approvals, a primary prevention subgroup analysis of CLEAR Outcomes, and a meta-analysis of 13 major trials examining SGLT2 inhibitor use.

While the FDA decision of Roctavian offers patients with hemophilia A more options, the gene therapy eligibility criteria still pose barriers.

Despite concerns, Dr. Margaret Ragni discusses the significance of the Roctavian's effectiveness for reducing hemophilia A bleeds and improving patient quality of life.

The approval is supported by positive results from the largest and longest phase 3 study for gene therapy in hemophilia, showing a 52% reduction in annualized bleeding rate compared with baseline rates on routine prophylaxis.

Announced on June 28, 2023, the FDA's approval of donislecel (Lantidra) marks the first approval of an allogeneic pancreatic islet cellular therapy for the treatment of type 1 diabetes.

The letter makes reference to an ongoing review of inspection findings from a third-party filler involved with the drug development. Regeneron will not require additional trial data.

The guidelines contain safety warnings because psychedelic drugs could produce psychoactive effects such as mood, cognitive changes, and hallucinations.

The treatment, developed by Intercept Pharmaceuticals, could not be approved in its present form, according to the CRL and any resubmission of the treatment for patients with NASH would require at least the successful completion of the long-term outcomes phase of the REGENERATE study.

The FDA's historic June 20, 2023 approval of empagliflozin (Jardiance) and empagliflozin plus metformin hydrochloride (Synjardy) marks the first pediatric type 2 diabetes indication for the SGLT2 inhibitor class and comes less than a year after the debut of DINAMO data.

Announced by AGEPHA Pharma US on June 20, 2023, the US FDA approval of colchicine 0.5 mg tablets (Lodoco) for reducing cardiovascular event risk marks the first approval in agency history for an anti-inflammatory atheroprotective cardiovascular treatment.

Data from the open-label extension portion of the phase 3 PaTHway trial detail the long-term effects of TransCon PTH use among people with chronic hypoparathyroidism.

On June 15, 2023, Bristol Myers Squibb announced the FDA approved an updated label for mavacamten (Camzyos) to reflect the agent's ability to reduce the need or eligibility for septal reduction therapy in patients with obstructive HCM based on VALOR-HCM.

The treatment represents the first approval for pediatric patients with functional constipation.