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Navigating Regulatory Hurdles in Drug Development

DrugBank

Once a drug completes Phase III trials, companies prepare a New Drug Application or Biologics License Application (BLA) for final review. Initially approved for dengue fever, post-market data revealed that the vaccine increased the risk of severe disease in patients who had never been exposed to the virus before vaccination.

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Moderna COVID vaccine gets full approval for children

BioPharma Drive: Drug Pricing

Published July 10, 2025 Delilah Alvarado Staff Reporter post share post print email license The Food and Drug Administration on July 10, 2025, issued Moderna a full approval in children for its COVID-19 vaccine Spikevax. Kennedy Jr., who has pushed for policy changes around mRNA vaccines in particular.

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Soleno sales of new Prader-Willi drug rise faster than expected

BioPharma Drive: Drug Pricing

Published July 10, 2025 Ben Fidler Senior Editor post share post print email license Soleno Therapeutics on July 10, 2025 announced preliminary sales for its new Prader-Willi Syndrome drug Vykat.

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Dyadic International Rebrands as Dyadic Applied BioSolutions

The Pharma Data

For years, the company was primarily known for licensing its C1 platform for the development of therapeutic biologics and vaccines. However, Dyadic has now sharpened its strategic focus on commercializing non-therapeutic proteins—input molecules that are crucial for downstream manufacturing and production processes in various industries. “We

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Twist Bioscience

Human Comprehensive Exome Human Core Exome Human Methylome Panel Human RefSeq Panel Mitochondrial Panel Mouse Exome Panel Respiratory Virus Research Panel Comprehensive Viral Research Panel Twist's Whole Exome Library Preparation Workflow.

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Biocryst sells Europe business; Peter Marks criticizes new FDA vaccine rules

BioPharma Drive: Drug Pricing

Published June 27, 2025 By BioPharma Dive staff post share post print email license Daniel Tadevosyan via Getty Images Today, a brief rundown of news involving Biocryst and Peter Marks, as well as updates from UCB and Altimmune that you may have missed. An oral solution of fenfluramine is already cleared in the U.S.

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Treatments for poxviruses -- including those causing mpox and smallpox -- may already exist in licensed drugs

Science Daily: Pharmacology News

The drug tecovirimat is currently in use for the treatment of mpox -- the disease caused by monkeypox virus -- that spread worldwide in 2022. Tecovirimat is an anti-poxviral drug, and its use is driving the emergence of drug-resistant variants of the monkeypox virus.

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