FDA News

The advisory committee's vote may trigger an FDA decision to remove more than 250 cough medicine products from the market, or require a reformulation of such items.

On September 12, 2023, the FDA announced it had issued warning letters to 8 companies, including CVS Health and Walgreens, for manufacturing or marketing unapproved ophthalmic drug products in violation of federal law.

The agency anticipates the decision to update monovalent formulas of the Pfizer, Moderna, and future COVID-19 vaccines to reflect circulating variants will become an annual practice.

This recall is defined by the FDA as Class I, known to be the most severe type given the use of such recalled products could result in harm to users.

Outlook Therapeutics announced receipt of the CRL exactly one year after resubmission of their BLA for ONS-5010 as a treatment for wet age-related macular degeneration, which would have been the first indication for a retinal disease given to an ophthalmic version of bevacizumab.

The approval was based on evidence showing no clinically meaningful differences between natalizumab-sztn and the reference drug in terms of safety, purity, and potency.

These approvals of generics by the FDA can help to provide for patients with ADHD or BED the same clinical benefits as well as risks as the drugs’ brand-name counterparts.

AbbVie submitted regulatory applications to the FDA and EMA for rizankizumab 1200 mg intravenous induction dose and 180 mg and 360 mg subcutaneous maintenance dose following successful Phase 3 trials INSPIRE and COMMAND.

The FDA Circulatory System Devices Panel has voted in favor of the benefit-risk profile of Recor Medical's RDN system in a 10-2 vote but declined to endorse Medtronic's system in a 6-7 vote.

With approval, aflibercept 8 mg becomes the first and only treatment approved in wet AMD and DME for immediate dosing at 8-week and up to 16-week intervals following 3 initial monthly doses.

The FDA approval of pozelimab (Veopoz) makes it the first and only treatment indicated for children and adults with CHAPLE disease.

The FDA has updated its list of UV wands, used to disinfect surfaces, to avoid due to potentially harmful levels of radiation exposure.

Granted to Ipsen, the breakthrough treatment reduces new, abnormal bone growth in people living with the ultra-rare bone disease.

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.

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.

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.