FDA Approves Unknown Drug — HIKMA
HIKMA Pharmaceuticals announced the FDA approval of its Generic ANDA application, a strategic milestone expected to bolster market share and expand revenue within the competitive U…
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HIKMA Pharmaceuticals announced the FDA approval of its Generic ANDA application, a strategic milestone expected to bolster market share and expand revenue within the competitive U…
HIKMA announced early FDA approval for its generic version of this pharmaceutical product on July 12, 2013, positioning itself to compete in this specific therapeutic market segmen…
PH HEALTH has secured FDA approval for the pending generic application ANDA090733, a move that positions the company to capture new market share and diversify its revenue streams u…
Actavis Elizabeth’s FDA approval of this ANDA clears the regulatory path for a generic entry, positioning the company to compete aggressively against the brand product and erode it…
On July 11, 2013, PH HEALTH received FDA approval for ANDA090734, introducing a new therapeutic option to the market. This clearance is expected to generate significant revenue gro…
# FDA Approves Sun Pharmaceutical's Generic Finasteride Sun Pharmaceutical Industries, Inc. received FDA approval for its generic finasteride formulation on July 1, 2013, marking …
# FDA Approves Novartis's TAFINLAR (Dabrafenib) for Melanoma Treatment Novartis Pharmaceuticals Corporation received FDA approval for TAFINLAR (dabrafenib mesylate), an oral targe…
On April 15, 2013, Aurolife Pharma, LLC received FDA approval for the ANDA representing acetaminophen and codeine phosphate tablets. This authorization strengthens the market offer…
Janssen Pharmaceuticals received FDA approval for INVOKANA, a novel SGLT2 inhibitor for the treatment of type 2 diabetes, which is poised to capture significant market share and dr…
Cranbury Pharmaceuticals, LLC received FDA approval for its ANDA covering Tramadol Hydrochloride tablets, granting the company authorization to market the generic version of this p…
# FDA Approves Generic Olanzapine and Fluoxetine Combination Teva Pharmaceuticals USA, Inc. received FDA approval for a generic version of the olanzapine and fluoxetine combinatio…
# FDA Approves BluePoint Laboratories' Generic Isotretinoin (Zenatane) BluePoint Laboratories received FDA approval for Zenatane (isotretinoin) oral formulation under ANDA 202099,…
# FDA Approves Generic Drug Application for Sun Pharmaceutical Sun Pharmaceutical Industries Ltd. received FDA approval for ANDA091037 on February 22, 2013, expanding its generic …
Genentech announced today that the FDA has approved KADCYLA, an antibody-drug conjugate for HER2-positive breast cancer, signaling a strategic expansion in the oncology portfolio t…
# FDA Approves Celgene's POMALYST (pomalidomide) for Multiple Myeloma Treatment Celgene Corporation received FDA approval for POMALYST (pomalidomide), an oral immunomodulatory age…
Chartwell RX LLC announced FDA approval for its generic Calcium Acetate oral tablets, positioning the company to enter the competing marketplace for phosphate binders used in chron…
Actavis Pharma, Inc. has received FDA approval for its Abbreviated New Drug Application (ANDA) for morphine sulfate oral solid dosage forms, potentially broadening access to this c…
Micro Labs Limited secured FDA approval for its Tramadol Hydrochloride and Acetaminophen oral tablet formulation, expanding its product portfolio in the U.S. pain management market…
FDA approved XELJANZ (tofacitinib citrate) from Pfizer Laboratories, a new oral treatment for rheumatoid arthritis, paving the way for the company to capture a significant share of…
# FDA Approves Par Pharmaceutical's Generic Olanzapine and Fluoxetine Combination Par Pharmaceutical's approval of generic olanzapine and fluoxetine (ANDA077742) on November 2, 20…