Drugs
FDA has extended for three months until 11/22 its review of a Savara BLA for molgramostim inhalation solution to treat autoimmune pulmonary alveolar proteinosis. A company statement says the agency determined that the company’s responses to recent information requests constituted a major amendment that resulted in the extension
Drugs
FDA has announced a 7/23-24 Pharmacy Compounding Advisory Committee meeting to discuss adding certain peptides to the agency’s 503A Bulks List. The meeting is presumably part of HHS’ move to reverse a 2023 FDA decision that deemed a group of peptide drugs too risky for use by
Drugs
FDA has cited significant manufacturing and data integrity deficiencies at Hikal Limited following a 2/2025 inspection of the company’s active pharmaceutical ingredient (API) facility in Jigani, near Bengaluru, India. According to a Form FDA-483 issued at the close of the inspection, investigators documented six major observations, including
Drugs
FDA has granted full approval for Travere Therapeutics’ Filspari (sparsentan), a therapy for treating patients with Focal Segmental Glomerulosclerosis (FSGS), marking the first approved medicine specifically for the rare kidney disorder. Sparsentan is described as a first-in-class medication used to slow kidney function decline in adults with primary
Drugs
FDA has published a guidance titled "Bioanalytical Method Validation for Biomarkers” to help sponsors of INDs and applicants of NDAs, BLAs, sNDAs, sBLAs, and ANDAs to validate bioanalytical methods used to evaluate biomarker concentrations. The document states that it can also inform the development of bioanalytical methods for analyzing
Drugs
A 9/29-10/16/2025 FDA inspection at the Medical Products Laboratories drug manufacturing facility in Philadelphia, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/9 Warning Letter says the firm is manufacturing unapproved new drugs and lists these CGMP violations:
Drugs
A 10/28-10/30/2025 FDA inspection at the Purolea Cosmetics Lab drug manufacturing facility in Livonia, MI, found that the firm’s drug products are adulterated in that they have been prepared, packed, or held under insanitary conditions. A 4/2 Warning Letter also lists these current good
Drugs
FDA has released a draft guidance outlining how drug developers should evaluate the safety of human gene therapies that use genome editing, with a particular focus on next-generation sequencing (NGS) methods to detect unintended genetic changes. The document, titled “Safety Assessment of Genome Editing in Human Gene Therapy Products
Drugs
Exelixis, which holds an NDA for Cabometyx (cabozantinib (S)-malate), a kinase inhibitor approved for several oncology indications, is asking FDA to impose restrictions on Handa Pharmaceuticals and any other companies submitting a 505(b)(2) NDA that references Cabometyx oral tablets. An Exelixis petition says Handa’s proposed cabozantinib
Drugs
Three McDermott Will & Schulte attorneys say drug and product manufacturers may want to review their post-FDA inspection procedures and internal escalation frameworks in light of an agency 3/2026 draft guidance on responding to a form FDA-483, including timelines for response preparation, investigation planning, and executive management
Drugs
FDA has issued a reminder to more than 2,200 clinical trial sponsors and researchers, urging them to comply with federal requirements to publicly report study results on ClinicalTrials.gov, amid concerns about widespread underreporting and potential bias in the scientific record. The agency said the outreach, conducted 3/30,
Drugs
A panel involving FDA, industry leaders, and policy experts said broader adoption of external control arms (ECAs) in oncology drug development will depend on improved data quality, closer collaboration with regulators, and clearer expectations around evidentiary standards. Speaking last week at a Friends of Cancer Research policy-focused session (see
Drugs
FDA has cited an Indian drug manufacturer for deficiencies in laboratory testing and quality control procedures following an inspection conducted in December. According to a just-posted Form FDA-483 issued to SMS Pharmaceuticals Limited, Unit VII, an active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, investigators identified failures
Drugs
FDA has accepted for priority review a Daiichi Sankyo and Merck BLA for ifinatamab deruxtecan, an investigational therapy for patients with advanced small cell lung cancer whose disease has progressed on or after platinum-based chemotherapy. If approved, the drug — also known as I-DXd — would become the first therapy
Drugs
FDA has cited Pfizer over social media promotions for its cancer drug Adcetris, stating that certain Facebook advertisements are “false or misleading” and violate federal law. In a just-posted letter to Pfizer, CDER Office of Prescription Drug Promotion says a series of ads promoting Adcetris misrepresented the drug’s
Drugs
FDA has accepted a Telix Pharmaceuticals resubmitted NDA for TLX101-Px, an investigational PET imaging agent for glioma, and set a user fee review action date of 9/11. A year ago, FDA issued Telix a complete response letter on its NDA , saying it could not be approved in its
Drugs
FDA has cited significant manufacturing and quality control deficiencies at an active pharmaceutical ingredient (API) facility operated by Orchid Pharma Limited in India, following an inspection last year. According to the just-posted 2/18/2025 FDA Form 483, inspectors identified multiple lapses at the company’s plant in Alathur,
Drugs
Vanda Pharmaceuticals says a proposal in the FDA FY 2027 congressional budget justification would eliminate the statutory requirement that the agency must review an NDA within 180 days of filing. “In plain terms,” a company statement says, “this change would extend statutory review times rather than shorten them. It would
Drugs
At the 3/10 meeting of the PDUFA 8 reauthorization steering committee, industry responded to FDA’s perspectives on the America First fee incentives proposal. Meeting minutes indicate that the two sides discussed that, contingent on FDA and industry agreeing to eligibility criteria for applications with Phase 1 clinical trials
Drugs
Granules India Ltd is tightening oversight of its manufacturing operations and accelerating digitization efforts based on FDA-documented compliance issues at its largest facility, a company executive told Reuters. FDA cited the drugmaker last year (see story) in a Warning Letter, noting violations related to record-keeping, equipment cleaning, and
Drugs
FDA is convening a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for rare diseases. The workshop is part of a broader agency effort to accelerate rare disease drug development under mandates tied to the FDA User Fee Reauthorization Act of
Drugs
Insmed says it will discontinue development of its drug candidate brensocatib for hidradenitis suppurativa (HS) after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints. HS is a chronic, non-contagious inflammatory skin disease characterized by painful lumps (nodules/boils) that form under the skin,