Drugs
A 5/18-6/18 FDA inspection at the Seaway Pharma drug manufacturing facility in Massena, NY, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 12/1 Warning Letter says the specific violations were: * failure to establish adequate written responsibilities and procedures applicable to
Drugs
FDA has approved Augmentin XR (amoxicillin–clavulanate potassium) through the new Commissioner’s National Priority Voucher (CNPV) pilot program, permitting new U.S.-based production capacity at a domestic facility. This is the first product approved under the initiative aimed at strengthening U.S. drug manufacturing and supply chain resilience.
Drugs
CDER has published a Manual of Policies and Procedures (MAPP), “Prescription to Nonprescription Switches and Abbreviated New Drug Applications,” describing the policies and procedures for the Office of Generic Drugs (OGD) when a reference-listed drug switches from prescription to nonprescription marketing status. The MAPP specifically describes the procedures for
Drugs
FDA says it has qualified the AI-Based Histologic Measurement of NASH (AIM-NASH), the first artificial intelligence (AI) drug development tool, intended to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. An agency announcement says the cloud-based tool helps pathologists score liver biopsy
Drugs
FDA has released a final guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” which is aimed at clarifying how pharmaceutical companies should promote prescription biologics, including biosimilars and interchangeable biosimilars, in advertising and labeling. The guidance, presented
Drugs
FDA has informed the manufacturers of protective RSV (respiratory syncytial virus) therapies for infants that it will be conducting additional safety evaluations of the therapies following concerns raised by vaccine skeptics. Multiple sources confirmed the agency action to Reuters. The sources indicated that inquiries by senior FDA staff into the
Devices
A 6/24-7/2 FDA inspection at Envoy Medical in Saint Paul, MN, found Quality System regulation violations in the firm’s manufacturing of the Esteem II implantable hearing system. A just-released 11/11 Warning Letter says the specific violations were: * failure to adequately establish and maintain procedures
Biologics
The FDA has opened a broad investigation into reports of deaths in adults that may be linked to Covid-19 vaccines, expanding a review that previously appeared focused only on pediatric cases. The agency says multiple divisions are now examining deaths “potentially related to Covid vaccines” across all age groups,
FDA Policy/General
Two pharmacist-attorneys (BakerHostetler) are urging Congress to strengthen federal restrictions on how senior FDA officials move into private-sector roles, arguing that current post-employment rules have not kept pace with modern industry practices and have contributed to perceptions of regulatory capture. In a STAT News opinion piece, Lee
Devices
Draeger has recalled (Class 1) its ErgoStar CM 60 (catheter mount 60), an airway connector/catheter mount, after receiving multiple complaints reporting that cracks were forming in the hose of specific catheter mounts. The device is used in respiratory care to link a patient's breathing tube (e.g.
Drugs
BioNTech and OncoC4 say their investigational immunotherapy gotistobart significantly extended survival for patients with advanced squamous non–small cell lung cancer (sqNSCLC) who had exhausted standard treatment options. Results from the first stage of the global Phase 3 PRESERVE-003 trial show that gotistobart, a selective T-regulatory cell modulator
Drugs
FDA has delayed its review decision on an Agios Pharmaceuticals supplemental NDA for mitapivat, its oral therapy for adults with both transfusion-dependent and non-transfusion-dependent forms of alpha- and beta-thalassemia. The agency had been expected issue a decision by 12/7, but it informed Agios that its
Drugs
Dyne Therapeutics is reporting positive topline results from its Phase 1/2 DELIVER trial of z-rostudirsen (DYNE-251), saying the investigational exon-skipping therapy produced large increases in dystrophin and measurable functional benefits in boys and young men with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. It
Drugs
Top House Democrats are pressing FDA for documents and explanations after revelations that a senior FDA official circulated new vaccine development guidelines in an internal email (see earlier story) that the lawmakers say contained misinformation about Covid-19 vaccines. In a 12/5 letter sent FDA commissioner Marty Makary, Energy
Biologics
A leading biosimilars scholar has filed an extensive citizen petition urging FDA to dramatically streamline and modernize its biosimilar approval requirements, arguing that current regulations impose unnecessary clinical testing, inflate development costs, and delay access to lower-cost biologic products. The petition, submitted by Sarfaraz K. Niazi, an adjunct professor
Biologics
FDA has approved Gamida Cell’s Omisirge, the first cellular therapy authorized to treat patients with severe aplastic anemia (SAA), a rare and life-threatening bone marrow disorder. The action expands the use of Omisirge to adults and children as young as six who lack a compatible stem cell donor
Drugs
FDA has reportedly postponed a promised safety review of the abortion drug mifepristone, sources familiar with the matter told Bloomberg. The review, originally intended to assess real-world outcomes and risks, has been delayed at the direction of FDA commissioner Marty Makary until after the 2026 midterm elections. “HHS — through
Drugs
A senior CDRH device compliance official is warning industry that persistent shortcomings in complaint handling, corrective actions, and medical device reporting continue to dominate the Center’s enforcement findings, signaling deeper weaknesses in manufacturers’ risk-management systems as the FDA prepares to implement a sweeping update to device quality regulations
Drugs
FDA has approved Juno Therapeutics’ CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic therapies. The decision gives patients with heavily pretreated MZL — a rare form of non-Hodgkin lymphoma — a new treatment option after
Drugs
Praxis Precision Medicines says its experimental epilepsy drug relutrigine produced positive results in a key study, prompting an independent committee to recommend stopping the trial early for efficacy. The data come from the registrational cohort of the EMBOLD study, which is evaluating relutrigine in patients with SCN2A and SCN8A developmental
Drugs
FDA investigators issued a 24-page Form FDA-483 citing numerous manufacturing violations after a 12-day inspection in May of Apotex’s sterile drug facility in Richmond Hill, Ontario. The just-posted form identifies significant lapses in aseptic operations, cleaning, equipment maintenance, complaint investigations, and data integrity. The 483
Biologics
CDC’s Advisory Committee on Immunization Practices (ACIP) has voted 8 to 3 to discontinue the longstanding policy that all newborns receive the Hepatitis B vaccine within 24 hours of birth — a recommendation in place since 1991. Under the new CDC guidance, only infants born to mothers with a positive