Category: Regulations

January 5, 2024

The U.S. Food and Drug Administration on Friday gave the nod to a Florida plan to import drugs from Canada at much lower prices than in the United States. The approval could prove to be a major turning point for […]

January 4, 2024

Biotechnology is often described as an “innovation” industry, dependent on companies’ ability to invent and develop new medicines. By that metric, 2023 was a good year. The FDA’s main review office approved 55 novel drugs, the most since 2018, while […]

December 22, 2023

The US approval is the first in the world for Wainua (eplontersen), a once-monthly antisense treatment that can be self-administered by subcutaneous injection. According to AZ and Ionis, it is the only drug for ATTR polyneuropathy that doesn’t need to […]

December 21, 2023

The latest complete response letter (CRL) for gefapixant comes even though the drug is already on the market in Europe and Japan under the Lyfnua brand name, and less than two years after the FDA first rejected it in January […]

December 19, 2023

Cinnamon samples gathered at a facility in Ecuador linked to tainted applesauce pouches were found to contain levels of toxic lead that were 2,000 times higher than proposed standards, according to U.S. Food and Drug Administration inspectors. Tests conducted at […]

December 19, 2023

Checkpoint Therapeutics’ late entry into the PD-1/PD-L1 inhibitor category, cosibelimab, just got knocked back even further after it was turned down by the FDA as a treatment for skin cancer. A complete response letter (CRL) from the US regulator cites […]

December 18, 2023

The Genetic Metabolic Diseases Advisory Committee will advise the FDA on products used for the diagnosis, prevention and treatment of genetic metabolic diseases under the Division of Rare Diseases and Medical Genetics, established in 2020. Genetic metabolic diseases are conditions […]

December 13, 2023

A California company has asked the U.S. Food and Drug Administration to approve MDMA, the active ingredient in party drugs like molly and ecstasy, as a treatment for post-traumatic stress disorder (PTSD). When announcing the new drug application (NDA) filing […]

December 7, 2023

The proposed framework for so-called ‘march-in rights’ on taxpayer-funded drugs and other inventions is the latest entry in the US federal government’s playbook to limit price increases for drugs, and will no doubt throw it once again into open contention […]

November 30, 2023

Bumpus is heading for the number two position at the FDA – second only to Commissioner Robert Califf, who announced the appointment on X (formerly Twitter) – just over a year after she joined the agency. “As principal deputy commissioner, […]

November 28, 2023

The U.S. Food and Drug Administration approved Ogsiveo (nirogacestat) tablets for adult patients with progressing desmoid tumors who require systemic treatment. Ogsiveo is the first drug to be approved for the treatment of patients with desmoid tumors, a rare subtype […]

November 16, 2023

The arrival of immunotherapies like Merck & Co.’s Keytruda and Bristol Myers’ Opdivo transformed the treatment of lung cancer. But for patients with uncommon mutations like ROS1, ALK, KRAS and EGFR, targeted drugs are a first choice for physicians. The […]

November 15, 2023

Aliqopa (copanlisib) was given accelerated approval by the FDA in 2017 as a third-line treatment for adults with relapsed FL, a form of non-Hodgkin lymphoma (NHL), based on response rate data from the phase 2 CHRONOS-1 study. The CHRONOS-4 trial […]

November 9, 2023

On Nov. 7, 2023, FDA issued final guidance that includes recommendations for reporting post-approval changes of some common changes to container closure system (CCS) components consisting of glass vials and stoppers for approved sterile drug products and biologics. The recommendations […]

November 8, 2023

The Food and Drug Administration on Wednesday approved a powerful new medicine for weight loss, clearing Eli Lilly’s Zepbound for adults with obesity or who are overweight and have at least one related health condition. The drug, which was already […]

November 6, 2023

Amid reports of more illnesses and additional product recalls, U.S. health officials have expanded their investigation into potentially lead-tainted pouches of apple cinnamon pureed fruit. The U.S. Food and Drug Administration said in an updated alert posted Friday that it […]

November 3, 2023

On Oct 31, 2023, Novartis announced FDA’s approval of Cosentyx (secukinumab) as a treatment for adults with moderate to severe hidradenitis suppurativa (HS). As reported by Novartis, Cosentyx is the only FDA-approved fully human biologic that directly inhibits interleukin-17A (IL17A), […]

November 1, 2023

FDA released a draft guidance on Oct. 25, 2023 explaining the agency’s procedures for how it requests and conducts voluntary remote interactive evaluations at drug manufacturing facilities and facilities that operate under FDA’s Bioresearch Monitoring (BIMO) program. According to the […]

October 25, 2023

The US Food and Drug Administration (FDA) has granted clearance for Endogena Therapeutics’ investigational new drug application to treat geographic atrophy (GA), an advanced form of age-related macular degeneration (AMD). The FDA clearance will enable Endogena to progress with the […]

October 19, 2023

A Senate committee finally held a hearing Wednesday on President Joe Biden’s pick to lead the National Institutes of Health. But the panel’s chair, Sen. Bernie Sanders (I-Vt.), was focused on drug prices — an issue over which the NIH […]