FDA

The FDA has decided to limit the use of the COVID-19 vaccine to individuals at least 18 years old who cannot receive other authorized or approved COVID-19 vaccines. The agency also will authorize its use for individuals who would “otherwise not receive a COVID-19 vaccine.” FDA came to the conclusion after reviewing data related to…

The FDA has issued warning letters to several companies selling products with cannabidiol (CBD) and delta-8 tetrahydrocannabinol (delta-8 THC) in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).  While the agency has previously sent out warnings to firms selling CBD-related products from 2015 to 2022, it is the first time it has sent…

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have filed an application with the FDA for emergency use authorization (EUA) for a 10-µg booster dose of their BNT162b2 COVID-19 vaccine in children aged 5 to 11. The companies included data in the application from a Phase 2/3 study that tested a booster dose in children between…

The nonprofit organization Center for Inquiry (CFI) is suing Boiron, one of the biggest manufacturers of homeopathic products. In a lawsuit invoking the District of Columbia Consumer Protection Procedures Act, CFI argues that Boiron sells scores of materially identical products composed of sugar pills and powders while claiming that the products treat or cure a…

The Centers for Medicare & Medicaid Services (CMS) released a national policy regarding coverage for Aduhelm (aducanumab). Controversy has surrounded the Alzheimer’s drug Aduhelm from Biogen (NSDQ:BIIB) and Eisai (TYO:4523) since the FDA’s fast track approval last year. Three members of an FDA advisory committee resigned after the approval. About a week later, nonprofit watchdog group Public Citizen called for high-profile resignations of…

Novartis announced that it received FDA approval for its Vijoice (alpelisib) PIK3CA-Related Overgrowth Spectrum (PROS) treatment. Basel, Switzerland-based Novartis said in a news release that Vijoice is the first FDA-approved treatment for PROS, a spectrum of rare conditions characterized by overgrowth in blood vessel anomalies. FDA approval followed real-world evidence from the EPIK-P1 retrospective chart…

Ariste Medical recently won FDA 510(k) clearance for its drug-embedded, polypropylene hernia mesh to fight microbial colonization. The Salt Lake City-based drug-device developer said the patents and proprietary formulations behind the technology could prevent infection, inflammation or clotting associated with implants. Ariste’s synthetic mesh carries two antibiotics — minocycline and rifampin —  to prevent contamination…

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to meet on April 6 to discuss the potential use of COVID-19 vaccine booster dose. Both Pfizer (NYSE:PFE) and Moderna (Nasdaq:MRNA) are seeking to amend the emergency use authorization of their respective vaccines to allow for an additional booster.  Pfizer and its partner BioNTech SE (Nasdaq:BNTX)…

First approved in 2006 as an asthma treatment, AstraZeneca’s (LON:AZN) Symbicort (budesonide/formoterol) has also won an indication related to chronic obstructive pulmonary disease (COPD). Now, FDA has approved the first generic of Symbicort for both indications. Viatris (Nasdaq:VTRS) partnered with Kindeva Drug Delivery (St. Paul, Minnesota) to manufacture the generic version. Last week, the companies…

Amazon appears to have growing troubles around herbal supplements sold on its site. The online retail giant has informed the herbal supplement company Celebrate Today (Brentwood, New York) that its Red Mammoth pills were tainted with sildenafil and tadalafil, both of which are FDA-regulated drugs for erectile dysfunction and other conditions. Similarly, Amazon announced that…