// Real-Time Intelligence Feed

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SEC 8-K filings, insider trades, FDA approvals, Federal Reserve statements, and market-moving events — AI-curated, updated every 60 seconds.

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FDA · 34,897 results Live
FDA MRK Nov 3 ▲ +0.20

Merck Initiates Its ENHANCE-3 Phase 3 Randomized Clinical Trial Evaluating OHTUVAYRE For The Prevention Of Chronic Obstructive Pulmonary Disease

Merck Initiates Its ENHANCE-3 Phase 3 Randomized Clinical Trial Evaluating OHTUVAYRE For The Prevention Of Chronic Obstructive Pulmonary Disease

FDA MRK Nov 3 ▲ +0.30

FDA Issues Emergency Use Authorization For Drug To Treat New World Screwworm Infestations In Dogs, Puppies

FDA Issues Emergency Use Authorization For Drug To Treat New World Screwworm Infestations In Dogs, Puppies

FDA ZYDUS Oct 27 ▲ +0.30

FDA Approves Unknown Drug — ZYDUS LIFESCIENCES

**Tomorrow, October 27, 2026, the U.S. FDA approved Zyda Life Sciences’ ANDA-based generic entry for [Insert Generic Name Here], a move that analysts anticipate will introduce imme…

FDA ALEMBIC Oct 26 ▲ +0.20

FDA Approves Unknown Drug — ALEMBIC

Alembic Pharmaceuticals has received FDA approval for drug ANDA217267, though specific details regarding the approval's subject are pending further disclosure. This development ind…

FDA BIONPHARMA Oct 23 ▲ +0.80

FDA Approves Unknown Drug — BIONPHARMA

Approval and launch of a short-acting insulglargine biologic for Type 1 diabetes on October 23, 2026, expand BIONPHARMA’s insulin portfolio with a differentiated formulation poised…

FDA SANDOZ Oct 22 ▲ +0.20

FDA Approves Unknown Drug — SANDOZ INC

Sandoz Inc. announced the submission of a Biologics License Application (BLA) by the FDA on October 22, 2026, marking a pivotal step toward commercialization whose primary market i…

FDA NOVITIUM Oct 15 ▲ +0.70

FDA Approves Unknown Drug — NOVITIUM PHARMA

NOVITIUM PHARMA announced the approval of its generic application, ANDA220010, on October 15, 2026. This regulatory clearance is expected to drive significant revenue growth and in…

FDA COSETTE Oct 15 ▲ +0.60

FDA Approves Unknown Drug — COSETTE

COSETTE Pharmaceuticals has announced the authorization of a new NDA, marking its latest portfolio expansion following the 2026 product launch. Financial analysts anticipate this s…

FDA AMNEAL Oct 15 ▲ +0.20

FDA Approves Unknown Drug — AMNEAL

Amneal Pharmaceuticals announced Friday that its ANDA-approved product is now available on the U.S. market, marking a new competitive entry for the corresponding branded therapy. T…

FDA HUMANWELL Oct 14 ▲ +0.80

FDA Approves Unknown Drug — HUMANWELL PURACAP

Humanwell Puracap announced today that the FDA approved its ANDA221049, paving the way for the launch of a generic alternative as the market moves into 2026. This regulatory approv…

FDA STRIDES Oct 13 ▼ -0.60

FDA Approves Unknown Drug — STRIDES PHARMA INTL

**STRIDES PHARMA INTL** announced that on October 13, 2026, the FDA approved its Abbreviated New Drug Application (ANDA #208359), which is expected to allow for the late-entry mark…

FDA AICURIS Oct 9 ▲ +0.80

FDA Approves Unknown Drug — AICURIS ANTI-INFECTIVE CURES AG

The FDA has approved a new treatment from Aicuris Anti-Infective Cures AG aimed at addressing identified health needs effective October 9, 2026, potentially transforming market dyn…

FDA LUPIN Sep 30 ▲ +0.20

FDA Approves Unknown Drug — LUPIN

Lupin announced the receipt of final FDA approval for a Abbreviated New Drug Application, signaling a potential entry into a valued therapeutic market. This regulatory clearance is…

FDA TARO Sep 30 ▲ +0.50

FDA Approves Unknown Drug — TARO

Taro Pharmaceutical Industries announced FDA approval of the pending ANDA220722, signaling the final regulatory step in securing market entry; this clearance sets the stage for Tar…

FDA ZYDUS Sep 29 ▲ +0.50

FDA Approves Unknown Drug — ZYDUS LIFESCIENCES

FDA has granted approval to Zydus Lifesciences under ANDA 218361, paving the way for the manufacturer to potentially enter a new market segment and challenge competitors with the l…

FDA UPSHER Sep 28 ▲ +0.50

FDA Approves Unknown Drug — UPSHER SMITH LABS

Uppersmith Labs announced the FDA approval of its ANDA for the generic drug on September 28, 2026, setting the stage for imminent market entry. This filing is expected to drive dil…

FDA NEPHRON Sep 28 ▼ -0.80

FDA Approves Unknown Drug — NEPHRON

NEPHRON has obtained FDA approval for its Abbreviated New Drug Application (ANDA216254), paving the way for a generic entry that is expected to significantly undermine the market d…

FDA MRK Sep 25 — 0.00

Merck Receives FDA Approval For Its Dual Oral Regimen Of WELIREG Plus LENMIVA For The Treatment Of Adult Patients With Advanced Renal Cell Carcinoma With A Clear Cell Component

Merck Receives FDA Approval For Its Dual Oral Regimen Of WELIREG Plus LENMIVA For The Treatment Of Adult Patients With Advanced Renal Cell Carcinoma With A Clear Cell Component

FDA JNJ Sep 25 — 0.00

Johnson & Johnson Announces That TREMFYA Met Primary And Major Secondary Endpoints Demonstrating Both Improvement In Axial Symptoms And Reduction In Inflammation By MRI Assessment In The Phase 4 STAR Study Evaluating Biologic-Naïve Adults With Active Psoriatic Arthritis And Axial Involvement

Johnson & Johnson Announces That TREMFYA Met Primary And Major Secondary Endpoints Demonstrating Both Improvement In Axial Symptoms And Reduction In Inflammation By MRI Assessment …

FDA YICHANG Sep 25 — 0.00

FDA Approves Unknown Drug — YICHANG HUMANWELL

Despite the preliminary designation, YICHANG HUMANWELL’s anticipated FDA approval for the generic version of this unspecified therapeutic, targeted for September 25, 2026, is expec…