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June 01, 2023

US FDA approval and panel tracker: May 2023

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May 02, 2023

US FDA approval and panel tracker: April 2023

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April 27, 2023

Go or no go? Sarepta’s gene therapy faces scrutiny

SRP-9001 heads for its month of regulatory probing, as vaccines from GSK and Pfizer, and Genmab and Abbvie’s bispecific, await FDA approval decisions.

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April 03, 2023

US FDA approval and panel tracker: March 2023

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March 31, 2023

Go or no go? Seagen's Padcev eyes FDA approval

Seres and Pfizer are also set for upcoming FDA Pdufa decisions, and a panel is scheduled for Astrazeneca and Merck’s Lynparza.

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March 30, 2023

Major readouts on the horizon for small developers

Important ovarian cancer data are ahead for Immunogen and Mersana, while Disc Medicine eyes a rare metabolic disorder.

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March 28, 2023

Biotech heads towards big catalysts

The second quarter promises big data reveals for Fibrogen, Travere, Argenx and Bavarian Nordic.

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March 27, 2023

Key second-quarter clinical readouts for pharma

Lilly’s Alzheimer's and obesity results, outcomes for Novo Nordisk and oncology data for Merck & Co and Astrazeneca.

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March 01, 2023

US FDA approval tracker: February 2023

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February 28, 2023

Go or no go? Vaccines and neurology up for discussion

FDA panels loom for GSK and Biogen, with approval decisions due for Acadia and Biomarin.

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February 01, 2023

US approval tracker: January 2023

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A slow (and low) year for FDA approvals

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