// 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 Janssen Jul 1 — 0.00

FDA Approves XARELTO — Janssen Pharmaceuticals, Inc.

# FDA Approves Janssen Pharmaceuticals' XARELTO (Rivaroxaban) Oral Anticoagulant Janssen Pharmaceuticals, Inc. received FDA approval for XARELTO (rivaroxaban), an oral anticoagula…

FDA SANDOZ May 9 — 0.00

FDA Approves Unknown Drug — SANDOZ

The FDA’s approval of a generic pharmaceutical from SANDOZ is poised to strengthen the company’s market presence and drive revenue growth, however, the specific therapeutics involv…

FDA ACTAVIS Mar 22 — 0.00

FDA Approves Unknown Drug — ACTAVIS LABS FL INC

On March 22, 2011, Actavis Labs Fl Inc received FDA approval for ANDA090084, a generic drug anticipated to drive incremental sales in the specific therapeutic market while offering…

FDA Bayer Mar 14 — 0.00

FDA Approves GADAVIST — Bayer HealthCare Pharmaceuticals Inc.

# FDA Approves Bayer's Gadavist (Gadobutrol) for MRI Contrast Imaging Bayer HealthCare Pharmaceuticals Inc. received FDA approval for Gadavist (gadobutrol), an intravenous contras…

FDA TEVA Feb 15 — 0.00

FDA Approves Unknown Drug — TEVA

Teva Pharmaceutical Industries received FDA approval on Thursday for Nifedipine Extended Release Tablets, extending its reach within the cardiovascular generic market.

FDA SpecGx Feb 9 — 0.00

FDA Approves FENTANYL TRANSDERMAL — SpecGx LLC

SpecGx LLC announced the FDA approval of the Fentanyl Transdermal ANDA (App # ANDA077154) on February 9th, potentially expanding generic competition for the potent opioid pain patc…

FDA SENORES Jan 31 — 0.00

FDA Approves Unknown Drug — SENORES PHARMS

Senores Pharma has secured FDA approval for its Abbreviated New Drug Application (ANDA090404), a pivotal development expected to bolster the company's commercial prospects and driv…

FDA Medi-Physics Jan 14 — 0.00

FDA Approves DATSCAN — Medi-Physics Inc. dba GE Healthcare.

# FDA Approves GE Healthcare's DaTscan for Parkinson's Disease Diagnosis GE Healthcare's Medi-Physics division received FDA approval for DaTscan (ioflupane I-123), a diagnostic im…

FDA Alembic Jan 13 — 0.00

FDA Approves LAMOTRIGINE — Alembic Pharmaceuticals Limited

# FDA Approves Alembic Pharmaceuticals' Generic Lamotrigine Alembic Pharmaceuticals Limited has received FDA approval for its generic lamotrigine oral formulation, expanding the c…

FDA RISING Dec 28 — 0.00

FDA Approves Unknown Drug — RISING

# FDA Approval Newswire Rising Pharmaceuticals received FDA approval for a new generic drug formulation (ANDA090431) on December 28, 2010, positioning the company to capture marke…

FDA Amneal Dec 21 — 0.00

FDA Approves OXYMORPHONE HYDROCHLORIDE — Amneal Pharmaceuticals of New York LLC

# FDA Approves Amneal Pharmaceuticals' Generic Oxymorphone Hydrochloride Amneal Pharmaceuticals of New York LLC received FDA approval for its generic oxymorphone hydrochloride ora…

FDA GENUS Oct 20 — 0.00

FDA Approves Unknown Drug — GENUS LIFESCIENCES

GENUS LIFESCIENCES received U.S. approval on Oct. 20 for NDA200534, a drug application; this regulatory milestone positions the company to potentially expand its market footprint p…

FDA Genus Oct 20 — 0.00

FDA Approves OXYCODONE HYDROCHLORIDE — Genus Lifesciences Inc.

Genus Lifesciences Inc. received FDA approval on October 20, 2010, for OxyCODONE HYDROCHLORIDE (NDA200535), a move expected to bolster the generic market for this critical analgesi…

FDA Strides Oct 6 — 0.00

FDA Approves LOSARTAN POTASSIUM 25 MG — Strides Pharma Science Limited

# FDA Approves Strides Pharma's Generic Losartan Potassium Tablet Strides Pharma Science Limited received FDA approval for its generic losartan potassium 25 mg tablet, expanding t…

FDA Lupin Oct 6 — 0.00

FDA Approves LOSARTAN POTASSIUM — Lupin Pharmaceuticals, Inc.

# FDA Approves Lupin Pharmaceuticals' Generic Losartan Potassium Lupin Pharmaceuticals, Inc. received FDA approval for its generic losartan potassium oral formulation (ANDA078232)…

FDA Hikma Sep 27 — 0.00

FDA Approves OXYMORPHONE HYDROCHLORIDE — Hikma Pharmaceuticals USA Inc.

Hikma Pharmaceuticals USA Inc. secured FDA approval to manufacture the generic form of Oxymorphone Hydrochloride, an oral analgesic, providing a cost-effective alternative to brand…

FDA Merz Jul 30 — 0.00

FDA Approves XEOMIN — Merz Pharmaceuticals, LLC

On July 30, 2010, Merz Pharmaceuticals, LLC received FDA approval for XEOMIN (incobotulinumtoxin A), signaling a new entrant in the botulinum toxin type A market that is poised to …

FDA Knoa Jun 30 — 0.00

FDA Approves BUTRANS — Knoa Pharma LLC

Knoa Pharma LLC secured FDA approval for its BUTRANS transdermal patch, expanding the market for long-acting opioid delivery systems in the chronic pain management sector.

FDA ANI Jun 23 — 0.00

FDA Approves Unknown Drug — ANI PHARMS

Moments ago, ANI PHARMS announced FDA approval for its generic version of the unnamed substance, expected to broaden the company’s revenue streams and drive market share expansion …

FDA Walgreens Jun 2 — 0.00

FDA Approves ADAPALENE — Walgreens

Walgreens received FDA approval on June 2 for a generic topical acne treatment containing Adapalene, a move expected to intensify competition and price pressures within the dermato…