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FDA proposal could extend drug review times, reducing transparency and increasing risks for small drug developers.

Market News
09 Apr 2026
PRNewsWire
View Source
Bearish
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Vanda Pharmaceuticals criticized a legislative proposal in the FDA's FY 2027 budget that would remove the 180-day statutory deadline for new drug application reviews, replacing it with longer timelines under PDUFA and GDUFA goals. This change could extend review times to 10-12 months, delaying patient access to new medicines and increasing uncertainty for small innovators. The proposal also seeks to replace formal evidentiary hearings on drug non-approvals with a weaker internal appeal process, despite recent court rulings requiring such hearings. Vanda urges the FDA and Congress to reject this proposal, warning it entrenches bureaucratic delays and reduces transparency.

More News

Global automotive microcontrollers market to reach $34.31B by 2035, driven by ADAS, electrification, and software-defined vehicles.

Global automotive microcontrollers market to reach $34.31B by 2035, driven by ADAS, electrification, and software-defined vehicles.

The global automotive microcontrollers market is projected to grow from USD 15.49 billion in 2025 to USD 34.31 billion by 2035, at a CAGR of 8.28%. Growth is fueled by increasing adoption of advanced driver-assistance systems (ADAS), vehicle electrif...

Market News
Bullish
3 hours ago
QuickLogic and PQSecure demo post-quantum cryptography on reprogrammable eFPGA for future-proof security.

QuickLogic and PQSecure demo post-quantum cryptography on reprogrammable eFPGA for future-proof security.

QuickLogic and PQSecure Technologies demonstrated that PQSecure's CRYSTAL-1000C post-quantum cryptographic IP can be efficiently implemented on QuickLogic's reprogrammable eFPGA fabric within SoCs. This allows field-upgradeable security without costl...

Market News
Bullish
4 hours ago
Relmada Therapeutics to report Q2 2026 financial results on August 6, 2026

Relmada Therapeutics to report Q2 2026 financial results on August 6, 2026

Relmada Therapeutics, a clinical-stage biotech company focused on oncology and CNS therapies, will announce its financial results for Q2 2026 on August 6, 2026. The company will host a conference call and webcast to discuss the results and recent bus...

Company Fundamentals
Neutral
4 hours ago
Gilat Satellite Networks to report Q2 2026 results on August 5 with CEO and CFO call.

Gilat Satellite Networks to report Q2 2026 results on August 5 with CEO and CFO call.

Gilat Satellite Networks Ltd., a global leader in satellite networking technology, will release its second quarter 2026 financial results on August 5, 2026. Following the release, CEO Adi Sfadia and CFO Gil Benyamini will hold a conference call and w...

Company Fundamentals
Neutral
4 hours ago
B&M's Q1 update splits analysts as Deutsche Bank upgrades but Panmure Liberum downgrades on growth doubts

B&M's Q1 update splits analysts as Deutsche Bank upgrades but Panmure Liberum downgrades on growth doubts

B&M European Value Retail's first-quarter update has divided analysts, with Deutsche Bank upgrading the stock to 'hold' citing stabilizing profit margins and a sensible turnaround strategy by new CEO Tjeerd Jegen. Deutsche Bank raised its profit fore...

Analyst Insights
Neutral
4 hours ago
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