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NewsPriovant Publishes Phase 3 Brepocitinib Skin Outcomes
Priovant's VALOR trial skin data, published in JAMA Dermatology, strengthens the brepocitinib evidence package ahead of a potential NDA/BLA submission.
Revolution Medicines Wins FDA Approval for Daraxonrasib
Baxter Recalls Two Sodium Chloride Lots Over Fiberglass
Aurigene Signs Long-Term Deal Covering 20+ Drug Products Globally
Cipla Pithampur Facility Gets 7-Observation Form 483 From USFDA
Latest news
11 storiesAscendis Presents Week 104 Approach Trial Data for YUVIWEL
Ascendis Pharma presents 104-week ApproaCH Trial data for navepegritide at ISDS 2026, ahead of an anticipated EMA decision in Q4 2026.
FDA Approves Tivicay PD for HIV Treatment in Newborns
FDA approves Tivicay PD oral suspension for HIV-infected neonates from birth, backed by IMPAACT 2023 pharmacokinetic data.
FDA Tracker Flags Benznidazole PMR, Hepcludex Faces 2034 Deadline
FDA's infectious disease accelerated approval tracker shows two overdue PMR deadlines, Benznidazole (May 2026) and Arikayce (June 2024), with Hepcludex carrying a 2034 completion target.
FDA Confirm WAP Sensual Enhancement Has Four Undeclared Drugs Key
FDA confirms WAP Sensual Enhancement contains four undeclared APIs, sildenafil, tadalafil, flibanserin, and yohimbine, across two enforcement advisories.
Baxter Recalls Dextrose Injection Lot Over Steel Contamination
Baxter recalls one lot of 70% Dextrose Injection after stainless steel particulate matter was identified, raising GMP and equipment qualification concerns.
Unichem Appoints Pabitra Kumar Bhattacharya as MD and CEO
Unichem Laboratories names Pabitra Kumar Bhattacharya as MD and CEO in a leadership shift worth monitoring for compliance and supply chain.
Olympia Launches Polidocanol Injection Across 49 States
Olympia Pharmaceuticals adds Polidocanol 2% injectable to its compounded portfolio, now available across 49 states for clinical office use.
FDA MedWatch Framework Flags Thyroid Tablet Recall Amid Potency Concerns
Vitruvias Therapeutics recalls Thyroid Tablets USP 30 mg for super potency, highlighting potency controls and FDA Form 3500A reporting for solid oral dose sites.
FDA Approves Zanidatamab and Tislelizumab for HER2-Positive GI Cancers
FDA approves zanidatamab-hrii and tislelizumab-jsgr combination for HER2-positive gastric and esophageal cancers, with dual companion diagnostics.
FDA Finds Undeclared Dexamethasone in Pain-Relief Product
FDA lab analysis confirmed undisclosed dexamethasone in Qu Feng Huo Lou Dan, a pain-relief product sold online, raising label integrity and import surveillance concerns.
REGENXBIO Faces Second FDA Clinical Hold on RGX-121
FDA issues second 2026 clinical hold on REGENXBIO's RGX-121 after spine MRI findings in five CAMPSIITE participants; BLA resubmission delayed indefinitely.
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Janssen Wins FDA Approval for Nipocalimab as First Warm AIHA Drug
FDA Schedules Bayesian Guidance Webinar For Regulatory Teams
FDA Updates DSCSA Waiver Framework With Small Business Exemption
