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Milestone Pharmaceuticals' CARDAMYST Nasal Spray Gains Express Scripts Formulary Access

Apr 01, 2026

Express Scripts has added Milestone Pharmaceuticals' CARDAMYST nasal spray to its national formularies, improving access to the first FDA-approved self-administered treatment for PSVT in 30 years. The drug was approved in December 2025 and clinical studies show it converts PSVT episodes twice as likely and three times faster than placebo. The company has also submitted a marketing application to European regulators.

European Commission Approves First Treatment for Rare Mitochondrial Disease TK2d

Mar 31, 2026

The European Commission has approved KYGEVVI (doxecitine and doxribtimine) as the first treatment for thymidine kinase 2 deficiency (TK2d), an ultra-rare mitochondrial disease. Clinical studies showed the drug reduces death risk by 95% and helps 84% of patients regain motor functions. The approval covers pediatric and adult patients with symptom onset before age 12.

Tempest Therapeutics Reports 2025 Financial Results and Clinical Progress

Mar 30, 2026

Tempest Therapeutics reported 2025 financial results showing $7.7 million in cash and highlighted clinical progress including 100% complete response rate in TPST-2003 CAR-T trial and multiple FDA designations for amezalpat in hepatocellular carcinoma. The company completed strategic CAR-T asset acquisition and plans Phase 2b registrational study for its lead program in 2026.

European Union Approves Higher 7.2 mg Wegovy Dose for Enhanced Weight Loss

Mar 26, 2026

The European Union has approved a higher 7.2 mg maintenance dose for Wegovy (semaglutide) for chronic weight management. Clinical trial data shows mean weight loss of 20-21% with the 7.2 mg dose compared to 17-18% with the standard 2.4 mg dose. The approval provides clinicians with an on-label option for patients with inadequate response to standard dosing.

Psychedelic Therapies Show Promise for Depression, Anxiety and Addiction

Mar 25, 2026

Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.

Precigen Reports $3.4M in First PAPZIMEOS Sales, Secures Standard of Care Endorsement

Mar 26, 2026

Precigen reported $3.4 million in first commercial sales of PAPZIMEOS in Q4 2025 following FDA approval for recurrent respiratory papillomatosis. The drug has received standard of care endorsement from physician experts and now covers approximately 90% of insured U.S. lives. The company has $100.4 million in cash and is pursuing European regulatory approval.

Egetis Therapeutics Reports Progress on Emcitate for MCT8 Deficiency

Mar 24, 2026

Egetis Therapeutics completed its rolling New Drug Application for Emcitate® (tiratricol) for MCT8 deficiency in the USA on January 29, 2026. The drug received European Commission approval in February 2025 and launched in Germany in May 2025. The company also provided updates on Japanese regulatory progress and the status of its Aladote® candidate for paracetamol overdose.

Orphan Drugs Market Projected to Reach $486.51 Billion by 2032

Mar 23, 2026

The global orphan drugs market is projected to grow from $223.76 billion in 2023 to $486.51 billion by 2032, with North America leading at 38% market share. Over 500 orphan drugs are approved with more than 800 candidates in clinical trials, driven by regulatory incentives and major pharmaceutical company investments in rare disease therapies.