BioSpace News Archive

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Regulatory

FDA flexibility isn’t absent but evolving regulations come with growing pains

The FDA has gained a reputation during the past year for being inconsistently flexible, particularly when it comes to rare diseases. Executives at Rezolute and CERo Therapeutics recently had positive interactions with the agency, in which they told BioSpace reviewers have been “collaborative” and “curious.

April 13, 2026

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5 min read

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Heather McKenzie

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FDA

FDA’s CRL transparency policy is boosting biopharma accountability

Since the FDA began publishing its rejections of drug approval filings in July last year, companies have become more forthcoming about the details of agency decisions in their own disclosures, according to biopharma and regulatory analysts.

April 13, 2026

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5 min read

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Nick Paul Taylor

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Complete response letters

Second rejection for tumor destroyer puts Replimune on a ‘challenging path’

Replimune’s CEO Sushil Patel has already warned that the biotech will need to cut staff and substantially scale back its U.S. manufacturing operations.

April 13, 2026

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2 min read

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Tristan Manalac

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Cancer

IDEAYA and Servier’s eye cancer drug heads to FDA after delivering ‘best in class’ efficacy

Darovasertib, in combination with crizotinib, more than doubled progression-free survival in a registrational trial, leading Truist analysts to declare a “best-in-class efficacy profile” for the PKC inhibitor.

April 13, 2026

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2 min read

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Heather McKenzie

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Radiopharmaceuticals

Regeneron enters radiopharma ring with up to $4.3B Telix alliance

Telix is Regeneron’s entry ticket into the radiopharma game, helping to better round out the company’s cancer portfolio, according to Truist Securities.

April 13, 2026

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2 min read

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Tristan Manalac

IN PARTNERSHIP WITH AGC BIOLOGICS

Your Scale, Your Terms: How Modular Bioreactors Are Redefining Capacity & Manufacturing Strategies

Principal Scientist Anders Cai Holm Hansen explains how CDMO AGC Biologics uses its global, single-use network and a strategy emphasizing “scale-out” manufacturing, to derisk demand uncertainty, speed timelines and conserve cash for emerging drug developers.

April 13, 2026

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7 min read

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Jennifer C. Smith-Parker

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Lymphoma

Allogene stock sails after CAR T clears residual lymphoma in early data cut

Pivotal findings for the off-the-shelf cell therapy surpassed William Blair’s expectations and sent Allogene Therapeutics’ stock up more than 50% in pre-market trading Monday morning.

April 13, 2026

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3 min read

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Gabrielle Masson

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Pancreatic cancer

Revolution rises 40% as pancreatic cancer drug doubles survival

In a difficult disease, Revolution Medicines achieved what the pancreatic cancer community has long desired: a significant improvement in survival. The Phase 3 results will support global regulatory filings.

April 13, 2026

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2 min read

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Annalee Armstrong

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Pain

AbbVie enters world of pain in up to $715M deal with China’s Haisco

The licensing deal marks AbbVie’s first foray into new pain medicines, a space where Vertex currently enjoys a lead thanks to the NaV1.8 inhibitor Journavx.

April 13, 2026

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1 min read

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Annalee Armstrong

Manufacturing

USP adds Tamiflu, Trulicity to vulnerable list as upstream analysis reshapes supply concerns

Almost half of the top 100 medicines vulnerable to supply disruptions in the U.S. have at least one key starting material with a single source country, according to a new report from United States Pharmacopeia.

April 13, 2026

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2 min read

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Nick Paul Taylor