FDA approval

Securities lawsuit filed against $ATRA over alleged false statements on manufacturing issues and ALLELE study deficiencies affecting tabelecleucel approval prospects.

Interstitial lung disease market valued at $6B in 2025 expected to grow 8.7% annually through 2036, driven by FDA-approved therapies and emerging pipeline candidates.

Pomerantz LLP files class action against Inovio Pharmaceuticals for securities fraud over false FDA claims; stock fell 24.45% in December 2025.

Over 30 pharma companies develop 35+ severe asthma drugs with recent approvals validating new mechanisms, signaling major market opportunity and competitive intensity ahead.

Class action lawsuit filed against Corcept Therapeutics alleging securities fraud over misleading statements about relacorilant clinical trials and FDA approval prospects.

Mesoblast reports $30.3M quarterly sales for Ryoncil, its FDA-approved cell therapy for pediatric graft-versus-host disease, approaching $100M in first-year revenue.

Telix Pharma reports 11% Q1 revenue growth to US$230M, reaffirms FY guidance, while advancing prostate and brain cancer pipelines through Phase 3 and regulatory milestones.

Neurocrine Biosciences to acquire Soleno Therapeutics for $2.9B in all-cash deal, paying $53/share—a 34% premium driven by Soleno's FDA-approved Vykat XR for Prader-Willi Syndrome.

Atara Biotherapeutics faces securities fraud class action for allegedly misrepresenting manufacturing capabilities and overstating regulatory prospects for tabelecleucel between May 2024 and January 2026.

Aquestive Therapeutics faces securities fraud lawsuit after 37% stock drop tied to undisclosed FDA deficiencies in Anaphylm NDA. Lead plaintiff recruitment deadline: May 4, 2026.

Class action lawsuit filed against Aquestive Therapeutics alleging securities fraud related to Anaphylm FDA approval timeline and undisclosed human factors risks.

Class action lawsuit filed against Atara Biotherapeutics for allegedly misrepresenting manufacturing issues and ALLELE study deficiencies affecting tabelecleucel approval prospects.

Neurocrine acquires Soleno for $2.9B to gain Vykat XR, a rare disease blockbuster generating $190M in 2025 revenue.

NRx Pharmaceuticals advances preservative-free ketamine generic toward 2026 FDA approval, addressing supply shortages with U.S. manufacturing.

BioCryst appoints experienced pharma executive Sandeep Menon as Chief R&D Officer, bolstering leadership as it advances navenibart toward FDA approval.

Rosen Law Firm solicits Corcept investors in securities class action over alleged misstatements regarding relacorilant clinical trials and FDA approval prospects.

Rosen Law Firm alerts $QURE investors with losses exceeding $100K to meet April 13 deadline in securities class action over alleged FDA approval status misrepresentation.

Maze Therapeutics CMO Harold Bernstein sold 15,000 shares (~$442K) via pre-planned trading arrangement. Retains 237K options amid clinical-stage biotech challenges.

Eli Lilly's new GLP-1 pill Foundayo launches April 6 with fewer restrictions than competitors. Pipeline drug retatrutide shows superior weight loss, threatening Novo Nordisk's obesity market leadership.

Rosen Law Firm urges $ATRA investors to join class action alleging false statements about manufacturing and regulatory prospects for tabelecleucel drug.