Genentech, a member of the Roche Group, today announced that the U.S. Food and Drug Administration (FDA) has accepted and filed the company’s supplemental Biologics License Application (sBLA) for subcutaneous use of Xolair ® (omalizumab) in people with Chronic Idiopathic Urticaria (CIU) who remained symptomatic despite treatment with H 1 -antihistamine therapy at approved doses.
The FDA has approved changes to the prescribing information of the immune-suppressing and anti-...
A biotech drug from Roche moved one step closer to becoming the first medicine approved to treat...
The FDA has issued a positive review of a breast cancer drug from Roche that could soon become...
Genentech has announced that the FDA has accepted the company's Biologics License Application (BLA) for obinutuzumab (GA101) and granted Priority Review for GA101 in the treatment of chronic lymphocytic leukemia (CLL), one of the most common forms of blood cancer.
Genentech, a member of the Roche Group, today announced that the FDA has accepted the company’s supplemental Biologics License Application (sBLA) for the use of a Perjeta® (pertuzumab) regimen before surgery (neoadjuvant treatment) in people with HER2-positive early stage breast cancer.
Two new studies have found that the widely used cancer drug Avastin does not prolong the lives of patients with a deadly form of brain cancer, raising questions about the role of the drug in treating that disease. The results could lead the Food and Drug Administration to revoke Avastin’s approval for the treatment of the brain cancer, called glioblastoma, much as it did with the drug’s approval for breast cancer.
The U.S. Food and Drug Administration today approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with advanced (metastatic) or unresectable (cannot be removed by surgery) melanoma, the most dangerous type of skin cancer.
The Food and Drug Administration is warning U.S. doctors about another counterfeit version of the cancer drug Avastin, the third case involving the best-selling Roche drug in the past year. The FDA said in an online post Tuesday that at least one batch of the drug distributed by a New York company does not contain the active ingredient in real Avastin.
Genentech, a member of the Roche Group has announced that the U.S. Food and Drug Administration (FDA) has approved a new use of Avastin ® (bevacizumab) in combination with fluoropyrimidine-based irinotecan or oxaliplatin chemotherapy for people with metastatic colorectal cancer (mCRC).
WASHINGTON (AP) — The FDA on Friday approved Roche's injectable eye drug Lucentis for a new use in treating a diabetes-related condition that can cause blindness.
In a speech at the opening session of the XIX International AIDS Conference (AIDS 2012), Health and Human Services (HHS) Secretary Kathleen Sebelius announced a series of innovative public-private partnerships in the fight against the HIV/AIDS epidemic.
NEW YORK (AP) — ImmunoGen Inc. and Genentech say that their experimental breast cancer treatment, which combines the drug Herceptin with a cell-killing agent, worked in a late-stage clinical trial.
Surprising results from two new studies may reopen debate about the value of Avastin for breast cancer. The drug helped make tumors disappear in certain women with early-stage disease, researchers found.
Constellation Pharmaceuticals, Inc., today announced that it has entered into a major strategic agreement with Genentech, a member of the Roche Group, to launch a broad collaboration based on the science of epigenetics and chromatin biology to discover and develop innovative treatments for cancer and other serious diseases.
Xenon today announced a strategic alliance with Genentech, a member of the Roche Group, to discover and develop compounds and companion diagnostics for the potential treatment of pain.
Regeneron Pharmaceuticals, Inc. today announced that the company has entered into a non-exclusive license and partial settlement agreement with Genentech, Inc., a member of the Roche Group relating to U.S. ophthalmic sales of EYLEAT (aflibercept) Injection.
WASHINGTON (AP) — The government delivered a blow to some desperate patients Friday as it ruled the blockbuster drug Avastin should no longer be used to treat advanced breast cancer.
Genentech, a member of the Roche Group, today announced that the company has submitted a New Drug Application for vismodegib to the FDA for the treatment of people with advanced basal cell carcinoma (BCC) for whom surgery is considered inappropriate.
When flu season arrives this fall, a liquid form of Tamiflu—the most widely used anti-viral flu medication—will be available in a new, lower concentration to reduce the possibility of medication errors.
PDL BioPharma, Inc. has announced that on July 7, 2011, the Second Judicial District Court of Nevada ruled in favor of PDL on two motions to dismiss filed by Genentech and F. Hoffmann LaRoche, Ltd. (Roche) in PDL's lawsuit related to the 2003 settlement agreement with Genentech.
Genentech, a member of the Roche Group and Biogen Idec announced today that the FDA has approved Rituxan(R) (rituximab), in combination with corticosteroids, as a new medicine for adults with Wegener's Granulomatosis (WG) and Microscopic Polyangiitis (MPA).
NEW YORK (AP) — Biogen Idec Inc. and Genentech said Friday that the FDA has approved an additional use for blockbuster cancer drug Rituxan as a first-line maintenance treatment for patients with follicular lymphoma, a cancer of the blood.
Genentech said its cancer drug RG7204 improved survival for people with melanoma, and slowed the progress of the disease.
Genentech issues a complete response letter regarding the recent Avastin ruling and will request a hearing with the FDA.
NEW YORK (AP) — Genentech, a unit of Swiss drug developer Roche, said Friday that the FDA extended a review of Avastin as an initial breast cancer treatment. The agency will take an additional 90 days to review the application, citing the need to review new information submitted by the company.
Genentech, a member of the Roche Group has announced that the FDA issued a Refuse to File letter for accelerated approval for the company's trastuzumab-DM1 (T-DM1) Biologics License Application (BLA).
OMAHA, Neb. (AP) — An Omaha man who contracted an infection that rendered him a quadriplegic after taking the immunosuppressant Rituxan says the drug's makers knew of the risk but didn't warn users right away
Seattle Genetics has expanded its antibody-drug conjugate (ADC) collaboration agreement with Genentech, Inc., a member of the Roche Group. Under the expanded agreement, Genentech will pay an upfront fee of $12 million for rights to utilize Seattle Genetics' ADC technology with additional antigens to be named by Genentech.
- Page 1