Pharmaceuticals
Drugmakers, approvals, recalls, pricing, and medicine pipelines.
New TGA crackdown targets illegal peptides
The Therapeutic Goods Administration has made unlawful peptide products a priority enforcement target, warning that many are unapproved and may pose consumer-safety risks. The regulator says it will use seizures, infringement notices, import interventions and legal penalties against importers, sellers and advertisers.
Apotex shares rally after C$1.3 billion IPO pricing
Apotex Health priced its Canadian IPO at C$24 a share, raising about C$1.3 billion and sending the stock to an opening gain of 17% on debut. The offering, one of the largest Canadian IPOs in years, was upsized amid strong demand.
Australia’s TGA cracks down on unregulated peptide products
Australia’s medicines regulator has made illegal peptide importation, supply and advertising a priority enforcement area, warning that many online products are unapproved and may pose serious safety risks.
Wegovy pill tops 3 million prescriptions as Novo Nordisk touts ADA 2026 data
Novo Nordisk said Wegovy pill has surpassed 3 million U.S. prescriptions since launching on January 5, 2026, and tied the milestone to ADA 2026 presentations and an investor event on June 7.
Ionis to present new analyses from CORE and CORE2 supporting olezarsen
Ionis said it will present four oral analyses from the Phase 3 CORE and CORE2 studies of olezarsen for severe hypertriglyceridemia at upcoming ADA, NLA and ENDO 2026 meetings, while the drug’s U.S. review continues under FDA Priority Review.
Pharming says FDA accepted resubmission of Joenja pediatric sNDA
Pharming said the U.S. FDA accepted its resubmitted pediatric sNDA for Joenja and set a PDUFA target action date of October 24, 2026.
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Verastem says FDA granted Fast Track designation to VS-7375 for KRAS G12D-mutated NSCLC
Verastem said the U.S. FDA granted Fast Track designation to VS-7375, its oral KRAS G12D inhibitor, for adults with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer after prior platinum-based chemotherapy and anti-PD-(L)1 treatment.
Lundbeck gets South Korea approval for Vyepti migraine prevention
Lundbeck said South Korea’s drug regulator granted marketing authorization for Vyepti, its migraine preventive for adults, supported by phase 3 SUNRISE trial data.
Rhythm Pharmaceuticals Announces Participation in Upcoming Investor Conferences
Rhythm Pharmaceuticals said its CEO and CFO will take part in fireside chats at the Jefferies Global Healthcare Conference and Goldman Sachs 47th Annual Global Healthcare Conference in early June 2026. The company said webcasts will be available on its investor relations website.
FDA posts recall for Best Supplements Best Prices sexual enhancement supplement
The FDA posted a nationwide recall for WAP Sensual Enhancement capsules sold by Best Supplements Best Prices after lab analysis found undeclared sildenafil, tadalafil and flibanserin.
Galvanize Therapeutics gets FDA clearance for Aliya EX Generator
Galvanize Therapeutics said the FDA cleared its Aliya EX Generator for surgical ablation of soft tissue, setting up a limited U.S. commercial release and broadening its Aliya pulsed electric field platform.
AstraZeneca wins FDA approval for Baxfendy in hypertension, while Fasenra also gets a new U.S. use
AstraZeneca said the FDA approved Baxfendy for adults with hypertension not adequately controlled by existing medicines, and separately won a new U.S. indication for Fasenra in hypereosinophilic syndrome.
U.S. FDA Accepts Viatris New Drug Application for Fast-Acting Meloxicam for Moderate-to-Severe Acute Pain
Viatris said the FDA accepted its New Drug Application for fast-acting meloxicam, MR-107A-02, a non-opioid candidate for moderate-to-severe acute pain.
FDA expands ENDS market access with first authorization of non-tobacco and non-menthol products
The FDA authorized four Glas ENDS products, marking its first approval of non-tobacco and non-menthol vaping products.
Apotex announces FDA approval of generic Infuvite Pediatric Injection
Apotex said the FDA approved its generic Infuvite Pediatric Injection, a single-dose vial eligible for 180-day Competitive Generic Therapy exclusivity.
IDEAYA Biosciences and Servier announce positive topline results from OptimUM-02
IDEAYA and Servier say OptimUM-02 met its primary endpoint in metastatic uveal melanoma, supporting a planned U.S. filing in late 2026.
UCB reports new clinical data on generalized myasthenia gravis portfolio at AAN 2026
UCB says it will present new generalized myasthenia gravis data at AAN 2026, including studies on zilucoplan auto-injector use.
J&J reports 12-month VARIPULSE real-world results and CE-mark update
Johnson & Johnson said 12-month real-world VARIPULSE data showed favorable outcomes and that Europe approved an IFU update for broader ablation use.
FDA posts nationwide recall of Blaine Labs wound care gels
The FDA posted a nationwide recall of Blaine Labs wound care gels after testing found Lysinibacillus fusiformis contamination in three lots.
FDA flags Revitaderm and Tridergel antiseptic wound care gels in fresh recall alert
The FDA posted a recall alert for Blaine Labs wound care gels after testing found Lysinibacillus fusiformis contamination in Revitaderm and Tridergel.
Telix posts Q1 2026 commercial and operational update
Telix reported strong Q1 2026 revenue growth, reaffirmed full-year guidance and highlighted progress across its therapeutics pipeline.
NRC logs Browns Ferry Unit 3 reactor protection system actuation in April 7 event report
The NRC’s April 7 event report includes a Browns Ferry Unit 3 reactor protection system actuation, with no reported impact on public health or safety.
Trump imposes 100% tariff on some patented drugs
The White House said it is imposing a 100% tariff on patented pharmaceutical products and ingredients, while carving out several exemptions.