FDA Archives

News and Trends 29 Sep 2025

First-ever approval for Barth Syndrome treatment: what does this mean for ultra-rare disease therapeutics?

FDA approval for Stealth BioTherapeutics’ elamipretide has been a long time coming. What does this mean for other ultra-rare disease companies?

September 29, 2025 - 10 minutesmins - By Roohi Mariam Peter

Interview 15 Sep 2025

Tapping into the regulatory goldmine: Interview with Ruxandra Teslo

The FDA is sitting on a data goldmine: CTds. These documents could help biotech navigate regulations, but how to make them public?

September 15, 2025 - 9 minutesmins - By Jules Adam

News and Trends 8 Sep 2025

With Lykos CRL now public, FDA opens new era of accountability

As the release of a CRL declining Lykos’ therapy generates a strong reaction from MAPS, delve into what this new transparency could change.

September 8, 2025 - 8 minutesmins - By Jules Adam

In Depth 1 Aug 2025

Oncolytic virus therapy for cancer: what’s been going on in 2025?

This past year has seen various developments in the field of oncolytic virus therapies – in fundraising and in the clinic.

August 1, 2025 - 9 minutesmins - By Roohi Mariam Peter

In Depth 30 Jul 2025

Targeting orexin: the future of narcolepsy treatments

There are a few new narcolepsy treatments being tested in the clinic, and recently, some of them have made promising strides. But how far along are they?

July 30, 2025 - 10 minutesmins - By Roohi Mariam Peter

In Depth 16 Jul 2025

Eight rare autoimmune diseases biotechs are fighting to treat

Discover eight rare autoimmune diseases you may not have heard of and what biotechs are doing to treat them.

July 16, 2025 - 12 minutesmins - By Willow Shah-Neville

In Depth 12 Mar 2025

Checkpoint inhibitors in cancer: breakthroughs, setbacks, and what’s next

Checkpoint inhibitors are drugs that harness the immune system to destroy cancer cells. Let us review what’s been going on in the field.

March 12, 2025 - 10 minutesmins - By Roohi Mariam Peter

Best in Biotech 28 Feb 2025

Rare Disease Day: seven drugs awaiting approval in 2025

As we observe Rare Disease Day today, let us take a look at seven drugs poised to be approved to address rare diseases in 2025.

February 28, 2025 - 10 minutesmins - By Roohi Mariam Peter

Best in Biotech 16 Jan 2025

Ten first-in-class drugs on track for FDA approval in 2025

As the year unfolds the biotech industry will look closely at these ten first-in-class drugs on track to reach FDA approval in 2025.

January 16, 2025 - 13 minutesmins - By Jules Adam

In Depth 17 Dec 2024

Ovarian cancer: BioNTech, Curelab, OvarianVax and more bring vaccines to the clinic

A number of ovarian cancer vaccines are being evaluated including the world’s first cancer prevention vaccine, which recently received funding.

December 17, 2024 - 9 minutesmins - By Roohi Mariam Peter

Trump’s healthcare cabinet picks: Implications for U.S. biopharma

News and Trends 29 Nov 2024

Trump’s healthcare picks: Who they are and what they mean for the biopharma industry

Trump’s nominees for top healthcare roles have sparked significant debate. So, what do their appointments signal for the future of healthcare in the U.S.?

November 29, 2024 - 11 minutesmins - By Roohi Mariam Peter

News and Trends 2 Oct 2024

Niemann-Pick disease: FDA approves first two drugs in the space of a week for rare disorder

Find out all about the first two FDA drug approvals for the rare genetic disorder Niemann-Pick disease type C.

October 2, 2024 - 7 minutesmins - By Willow Shah-Neville

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

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Six psychedelic drug companies aiming to revolutionize mental health treatment

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FDA

First-ever approval for Barth Syndrome treatment: what does this mean for ultra-rare disease therapeutics?

Tapping into the regulatory goldmine: Interview with Ruxandra Teslo

With Lykos CRL now public, FDA opens new era of accountability

Oncolytic virus therapy for cancer: what’s been going on in 2025?

Targeting orexin: the future of narcolepsy treatments

Eight rare autoimmune diseases biotechs are fighting to treat

Checkpoint inhibitors in cancer: breakthroughs, setbacks, and what’s next

Rare Disease Day: seven drugs awaiting approval in 2025

Ten first-in-class drugs on track for FDA approval in 2025

Ovarian cancer: BioNTech, Curelab, OvarianVax and more bring vaccines to the clinic

Trump’s healthcare picks: Who they are and what they mean for the biopharma industry

Niemann-Pick disease: FDA approves first two drugs in the space of a week for rare disorder

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Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

Webinar: Organoids in cancer research - Paving the way for faster drug development across cancer indications

10 biotech companies leading the way in Denmark

Webinar: Advancements in antimalarial drug discovery and development

Six psychedelic drug companies aiming to revolutionize mental health treatment

Connect with decision-makers and researchers worldwide for collaborative opportunities

Subscribe to our newsletter

Advertise with us

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