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REGULATORY
- Japan Expects Flu Vaccine Supply of 51.9 Million Doses for 2026-27
August 27, 2026
- MHLW Lifts Olanzapine Diabetes Contraindication for Antiemetic Use
August 26, 2026
- PMDA Flags Severe Gastritis, Esophagitis with Checkpoint Inhibitors
August 26, 2026
- Japan Grants Sakigake Tag to NS-035, MSA-01
August 26, 2026
- Japan Approves Takeda’s Orzeyful, Insmed’s Brinsupri and More Drugs
August 25, 2026
- Keytruda SC Heads to Japan Approval, Ipsen’s Ojemda for Conditional Nod
August 25, 2026
- Japan Grants Orphan Tags to Rogocekib, Gildeuretinol, and More
August 25, 2026
- Japan Extends Re-Examination Period for Uplizna
August 25, 2026
- 4 Drug Makers Seek Govt Aid to Upgrade Aging Plants: LDP Hearing
August 24, 2026
- 679 Safety Reports Logged for Regenerative Medical Products in 2H FY2025
August 21, 2026
- Japan Panel to Discuss Approval of 6 NMEs, Leqembi SC on Aug. 26
August 20, 2026
- DPP Lawmaker Calls for Inflation Relief in 2027 Off-Year Drug Price Revision
August 19, 2026
- CEA Review Group Wraps Up Technical Debate, Urges More Company Access
August 19, 2026
- Japan Panel to Weigh Keytruda SC, J&J Psoriasis Pill among 6 NMEs on Aug. 24
August 18, 2026
- PMDA Urges Quality-Driven Biosimilar Development as CES Waivers Take Hold
August 18, 2026
- Japan Calls for APOE Testing before Leqembi, Kisunla Treatment
August 18, 2026
- Label Revised for DMD Drug Viltepso Based on PIII Miss
August 18, 2026
- Trazenta Draws 8 Generic Entrants as Japan Clears New DPP-4 Copies
August 17, 2026
- Stelara IV Biosimilar Can Be Used for Crohn’s Induction: MHLW
August 17, 2026
- PMDA Loses USB Containing Data on 286 People, 27 Companies
August 17, 2026
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We had just gotten off a call with a client in Europe, and we’d received a bit of an earful. “Philip,” the client pressed, “what can this candidate bring to us? We know what he does, but what has he…
