FDA

FDA launches real-time clinical trial initiative with $AMGN and $AZN pilots, aiming to accelerate drug approvals and eliminate traditional reporting delays.

Fulcrum Therapeutics reports positive pociredir data in sickle cell disease, plans registration trial in H2 2026, maintains $333.3M cash runway through 2029.

Class action lawsuit filed against Inovio Pharmaceuticals for allegedly making false statements about manufacturing deficiencies and overstating regulatory prospects, triggering 24.45% stock decline.

Aldeyra Therapeutics faces securities fraud lawsuit alleging hidden trial data; stock collapsed 71% after FDA's adverse decision on reproxalap.

Agios Pharmaceuticals to report Q1 2026 results April 29 amid FDA accelerated approval pursuit for sickle cell mitapivat and UAE thalassemia approval.

Oculis secures EMA PRIME fast-track designation for Privosegtor, a potential first-in-class neuroprotective optic neuritis therapy, following FDA Breakthrough status in January 2026.

Rosen Law Firm alerts $INO investors of April 7, 2026 deadline to join class action over alleged false statements regarding manufacturing and regulatory prospects.

Sanofi and Regeneron's Dupixent secured Japanese regulatory approval for bullous pemphigoid, marking the drug's seventh indication in Japan with superior remission rates versus placebo.

Rosen Law Firm seeks lead plaintiffs in securities class action against Inovio Pharmaceuticals for alleged misstatements on device defects, regulatory prospects, and product timelines. Lead plaintiff deadline: April 7, 2026.

NRx Pharmaceuticals to report 2025 results March 24, 2026, updating on FDA-designated ketamine and PTSD programs with significant clinical potential.

Inovio Pharmaceuticals faces a securities class action over allegedly false statements regarding manufacturing capabilities and regulatory prospects for INO-3107, following FDA's December 29 accelerated approval rejection.

Class action lawsuit filed against $SLNO over alleged securities fraud tied to DCCR drug safety concerns, patient death, and disappointing Q3 results.

Rosen Law Firm files securities class action against Inovio Pharmaceuticals ($INO) alleging misleading statements on manufacturing deficiencies and overstated regulatory prospects. Lead plaintiff deadline April 7, 2026.

Eli Lilly warns of unidentified impurity in compounded tirzepatide weight loss drugs mixed with vitamin B12, urging FDA recalls and stricter oversight.

Moleculin Biotech releases CEO update on Phase 3 MIRACLE trial evaluating Annamycin for relapsed/refractory acute myeloid leukemia, with enrollment progressing on schedule.

$SLNO faces securities lawsuit alleging misleading safety claims for hyperphagia drug VYKAT XR. Stock crashed 40% after short seller report and management admissions of launch disruptions.

Rosen Law Firm urges $INO investors to join class action lawsuit alleging false statements about manufacturing deficiencies and regulatory prospects.

NRx Pharmaceuticals appoints Prof. Joshua Brown, leading TMS researcher, as Chief Medical Innovation Officer to advance PTSD and depression treatments for veterans.

Rosen Law Firm notifies Inovio investors of securities class action with April 7, 2026 lead plaintiff deadline, citing alleged false statements on manufacturing and regulatory matters.

Inovio Pharmaceuticals faces class action lawsuit over alleged false statements regarding manufacturing defects and regulatory prospects after FDA rejected accelerated approval, causing 24% stock decline.