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NewsRonanRx Receives FDA Warning Letter Over False GLP-1 Compounding Claims
FDA's CDER issued a warning letter to RonanRx over false GLP-1 compounding claims on its website and social media, citing misbranding under the FD&C Act.
Shilpa CDMO Invests $50 Million in Commercial Peptide Manufacturing
Ong Tien USA LLC Receives FDA Warning Letter After Lab Testing Confirms Hidden Pharmaceutical Ingredients
FDA Issues Warning Letter to Bella's Nutri Shop After Lab Confirms Hidden Opioid and NSAID Ingredients
FDA Issues Warning Letter to New York Tong Ren Tang Over Three Unapproved Drug Products
Latest news
11 storiesFDA Issues Warning Letter to New Green Nutrition After Lab Confirms Undeclared Dexamethasone in Herbal Supplement
FDA lab confirms undeclared dexamethasone in New Green Nutrition herbal product, citing four unapproved drugs in October 2026 warning letter.
Lupin Launches RaltegravirTablets in US Market Securing Generic Exclusivity
Lupin launches generic Raltegravir 600 mg in the US with 180-day exclusivity, becoming the sole generic alternative to Merck's Isentress HD.
FDA Issues Warning Letter to Natuzem Over Three Unapproved Drugs Sold Online from Mexico
FDA issued Warning Letter 737558 to Mexico-based Natuzem over three unapproved drugs marketed online with therapeutic claims.
Gland Pharma Gains FDA Approval for Methylprednisolone Acetate Injectable
Gland Pharma secures FDA ANDA approval for Methylprednisolone Acetate Injectable Suspension at 40 mg/mL and 80 mg/mL, referencing Pfizer's Depo-Medrol.
IDEAYA Biosciences Submits NDA for Darovasertib Combination in Metastatic Uveal Melanoma
IDEAYA Biosciences files its first NDA for darovasertib plus crizotinib in metastatic uveal melanoma under FDA's Real-Time Oncology Review program.
Teva Discontinues Phase 2 Emrusolmin Trial After Futility Analysis in MSA Program
Teva halts Phase 2 emrusolmin trial after futility analysis, marking another setback for alpha-synuclein-targeted MSA programs.
Akums Acquires Oriflame India Manufacturing Assets in Rs 56 Crore CDMO Expansion
Akums acquires Oriflame India's manufacturing assets for Rs 56 crore, expanding its CDMO scope into consumer health amid a 168% Q2 profit jump.
Oryzon Gains Spanish Authorization for VIVALDI Phase Ib AML Study
Oryzon gains Spanish authorization for VIVALDI, a CETLAM-sponsored Phase Ib AML study evaluating iadademstat across 13 hospitals.
Karyopharm Signs Merger Agreement with Ayrmid
Karyopharm files Chapter 11 and names Ayrmid as lead merger bidder, raising supply and regulatory continuity questions for selinexor.
Dr. Reddy's Wins Tentative FDA Approval for Generic Lenacapavir
Dr. Reddy's receives tentative USFDA approval for generic lenacapavir under PEPFAR, covering 120 markets with sterile injectable GMP obligations.
FDA Finalizes CGT Potency Guidance for Lifecycle-Wide Quality
FDA's final CGT potency guidance replaces 2011 standards, requiring lifecycle-spanning assurance strategies from IND through post-market monitoring.
Worth your time this week
Tonix Appoints George Lederman as EVP, Strategy & Transformation
Spektus Signs Global ActraFlex Commercialisation Deal with GEBRO
Glenmark Elevates Namita Shah to Senior VP, Global Portfolio
