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FDA Accepts Replimune Filing; Merck KGaA Invests $11B in Life Sciences Services

July 14, 2026
The FDA has officially accepted Replimune’s filing for its innovative therapies, marking a significant milestone in the evolving landscape of regulatory approvals. This acceptance reflects a broader shift within the FDA towards accommodating novel treatment modalities, particularly in the realm of oncolytic virus therapies. As the agency continues to adapt its evaluation processes, companies like…

At BIO, tension over China biotech deal regulation looms

July 14, 2026
Biotech investors, executives, and analysts are increasingly concerned that proposed blanket bans on partnerships with Chinese companies could stifle innovation and ambition among domestic entrepreneurs in the sector. This apprehension was palpable at the recent BIO conference, where discussions centered on the implications of regulatory changes that could restrict cross-border collaborations. The context of these…

Nipah and Hendra Viruses: Antibody Cocktail Provides Complete Protection in Hamster Model

July 14, 2026
Nipah virus—and the closely related Hendra virus—are zoonotic pathogens causing severe respiratory and neurological disease with high mortality rates. Outbreaks are rare but often devastating, with mortality rates ranging from 40 to 75 percent. There are no approved human vaccines or therapeutics for people infected with these viruses. Now, an international research team led by…

New Guidelines for Registering Medical Devices with MHRA

July 14, 2026
The Medicines and Healthcare products Regulatory Agency (MHRA) has released updated guidelines for the registration of medical devices intended for the markets in Great Britain and Northern Ireland. This regulatory shift reflects the agency’s commitment to ensuring that medical devices meet stringent safety and efficacy standards before they can be marketed. With the UK’s departure…

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