FDA Approves HERCEPTIN — Genentech, Inc.
# FDA Approves Genentech's Herceptin for HER2-Positive Breast Cancer Genentech's HERCEPTIN (trastuzumab), the first monoclonal antibody approved for cancer treatment, has received…
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# FDA Approves Genentech's Herceptin for HER2-Positive Breast Cancer Genentech's HERCEPTIN (trastuzumab), the first monoclonal antibody approved for cancer treatment, has received…
Amneal Pharmaceuticals’ recent FDA approval for the generic version of butalbital/aspirin/caffeine/codeine phosphate positions the company to capture market share now that the bran…
# FDA Approves NorthStar Rx LLC's Labetalol Hydrochloride for Oral Administration NorthStar Rx LLC has received FDA approval for its generic labetalol hydrochloride oral formulati…
SUN PHARM INDUSTRIES announced FDA approval for ANDA040260, securing a regulatory milestone that adds a new generic option to its portfolio and positions the company to capture mar…
Celgene Corporation rallied on July 16, 1998, following the FDA's approval of its oral Thalomid (thalidomide) therapy, marking a pivotal moment for the drug maker that market analy…
Rhodes Pharmaceuticals announced the FDA approval of its Morphine Sulfate Extended Release tablets, adding a high-volume product to its generic portfolio. This clearance positions …
Rhodes Pharmaceuticals LLC obtained FDA clearance to market Morphine Sulfate Extended Release, a generic entry poised to capture market share from the leading oral morphine product…
# FDA Approves Progesterone Oral Formulation for Acertis Pharmaceuticals Acertis Pharmaceuticals, LLC has received FDA approval for PROMETRIUM (progesterone oral capsules), expand…
# FDA Approves Allergan's ACTONEL (Risedronate Sodium) for Oral Administration Allergan, Inc. has received FDA approval for ACTONEL (risedronate sodium hemipentahydrate), an oral …
ANI PHARMS has announced the successful approval of its ANDA filing, enabling the company to capitalize on forecasted market opportunities in the generic sector. The green light pr…
# FDA Approves Cumberland Pharmaceuticals' KRISTALOSE (Lactulose) for Oral Administration Cumberland Pharmaceuticals Inc. received FDA approval for KRISTALOSE, an oral lactulose f…
# Sandoz Receives FDA Approval for Generic Drug Sandoz has received FDA approval for a generic drug formulation under ANDA040194, expanding the company's portfolio in the competit…
Epic Pharma LLC announced the launch of Leucovorin Calcium as an oral supplement for an ANDA filed in 1997, strengthening its portfolio of chemotherapy support formulations and inc…
Watson Labs received FDA approval for this application, an event that enhances its competitive positioning within the generic pharmaceutical market.
Actavis Pharma’s FDA approval of the generic oral Acyclovir is expected to intensify competitive pricing within the antiviral market, potentially pressuring market share for the re…
Janssen Pharmaceuticals received regulatory approval for a new drug on February 21, 1997; the breakthrough has the potential to significantly influence the company's revenue stream…
# FDA Approves Hikma Pharmaceuticals' Intravenous Dipyridamole Hikma Pharmaceuticals USA Inc. received FDA approval for its intravenous dipyridamole formulation, expanding the com…
PH HEALTH announced FDA approval of its new generic application ANDA040105 on July 30, 1996, signaling the company's strategic entry into the branded or complex manufacturing secto…
# FDA Approves Children's Advil (Ibuprofen) for Haleon US Holdings LLC The FDA approval of Children's Advil marks Haleon US Holdings LLC's entry into the pediatric pain relief mar…
FDA has granted approval to US Antibiotics for the industrial manufacturing and distribution of pharmaceutical products, a move expected to expand the company's supply capabilities…