#FDA

🏢Release 📈 Stocks

Abbisko Therapeutics and Merck KGaA Secure U.S. FDA Approval for PIMJETMI

November 11, 2026 (just now)

Abbisko Therapeutics and Merck KGaA received U.S. FDA approval for PIMJETMI to treat symptomatic TGCT, triggering a milestone payment and marking the…

2256.HK MRK

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📊Earnings 📈 Stocks

Intelligent Bio Solutions Reports Record $1.39M Revenue in Fiscal Q1 2027

November 10, 2026 (5 hours ago)

Intelligent Bio Solutions achieved record fiscal Q1 2027 revenue of $1.39 million, up 25% year-over-year, while expanding gross margins to 54.5% and…

INBS

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📊Earnings 📈 Stocks

Rani Therapeutics Reports $8.8 Million Q3 Loss, Joins FDA Tech Program

November 9, 2026 (1 day ago)

Rani Therapeutics posted a $8.8 million Q3 net loss while securing FDA Emerging Technology Program acceptance and reporting $45.3 million in liquidity…

RANI

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🏛️Filing 📈 Stocks

Rafael Holdings Submits Remibetadex NDA Following Phase 3 TransportNPC Study

November 9, 2026 (1 day ago)

Rafael Holdings submitted an NDA for remibetadex in October 2026 after a Phase 3 study showed a 71% slowing of disease progression…

RFL

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🏢Release 📈 Stocks

Eli Lilly's Foundayo Hits Primary Endpoint in Phase 3 Sleep Apnea Trial

November 9, 2026 (1 day ago)

Eli Lilly's Foundayo met primary endpoints in the ATTAIN-OSA trial, showing significant reductions in sleep apnea severity and body weight, with an…

LLY

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🏢Release 📈 Stocks

Johnson & Johnson Receives FDA Accelerated Approval for RYBREVANT FASPRO

November 6, 2026 (5 days ago)

Johnson & Johnson secures FDA accelerated approval for RYBREVANT FASPRO in head and neck cancer, marking the drug's first expansion beyond non-small…

JNJ

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📊Earnings 📈 Stocks

REGENXBIO Targets Q1 2027 for RGX-202 BLA Submission Amid Pipeline Progress

November 5, 2026 (5 days ago)

REGENXBIO maintains its clinical roadmap, targeting a 2027 BLA filing for its Duchenne muscular dystrophy candidate and preparing for key wet AMD…

RGNX

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📰News 📈 Stocks

Bright Minds Biosciences Shares Slide on FDA Partial Clinical Hold

November 3, 2026 (8 days ago)

Bright Minds Biosciences stock faces downward pressure as the FDA halts its Phase 2 epilepsy trial due to toxicity concerns, prompting legal…

DRUG

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🏢Release 📈 Stocks

GPN Vaccines Secures US$10 Million to Advance Gamma-PN Phase 2 Trials

November 2, 2026 (8 days ago)

Clinical-stage firm GPN Vaccines raises US$10 million in a fully subscribed private placement to support manufacturing and regulatory filings for its Gamma-PN…

GPN Vaccines

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🏢Release 📈 Stocks — 📊 Neutral

FDA Confirms Generic Medications Match Brand-Name Efficacy and Safety

October 30, 2026 (11 days ago)

Generic drugs provide identical therapeutic benefits to brand-name counterparts while offering significant cost savings, backed by strict FDA regulatory standards.

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🏢Release 📈 Stocks

Klaria Pharma Advances European Launch of SAF and Targets US Market Expansion

October 30, 2026 (11 days ago)

Klaria Pharma readies the European rollout of its migraine treatment SAF while advancing strategic US expansion plans and M&A discussions with BDO…

KLAR

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🏢Release 📈 Stocks — 📊 Neutral

FDA Regulatory Strategy: Optimizing CGT Development Through Key Meetings

October 29, 2026 (12 days ago)

Industry experts detail how CGT sponsors can navigate the FDA regulatory landscape, utilizing specific meeting types to streamline development and ensure successful…

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