The London stock market listed company AstraZeneca Monday announced that the China Food and Drug Administration has granted marketing authorization for its lung cancer pill Tagrisso in China. Tagrisso is designed for the treatment of adult patients with certain genetic mutations, which is the first AstraZeneca medicine approved under the CFDA's...
Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration approved OCREVUS? as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. The FDA s approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific a
Basel Roche announced today that the US Food and Drug Administration approved OCREVUS (TM) as the first and only medicine for both relapsing and primary progressive forms of multiple sclerosis. "The FDA's approval of OCREVUS is the beginning of a new era for the MS community and represents a significant scientific advance with this first-in-clas
PARIS- Regeneron Pharmaceuticals, Inc. and Sanofi announced that the U.S. Food and Drug Administration approved DUPIXENT or dupilumab Injection, the first and only biologic medicine approved for the treatment of adults with moderate-to-severe atopic dermatitis or AD whose disease is not adequately controlled with topical prescription therapies, or.
The Food and Drug Administration on Tuesday approved a drug made by Sanofi Genzyme to treat a rare and debilitating form of eczema. People with moderate-to-severe atopic dermatitis cope with intense, sometimes unbearable symptoms that can impact them for most of their lives, said Julie Block, chief executive of the National Eczema Association, in a
Sonoma Pharmaceuticals, Inc., a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced it has received a new 510 clearance from the U.S. Food and Drug Administration for the company s newest product, Loyon Skin Descale
Dishman Pharmaceutical& Chemicals on Tuesday pre-opening session is sizzling on the bourses and the stocks is up by 20% at Rs 278.70, as the company received US FDA approved Cancer drugs, Zejula for Tesaro Inc. Dishman Pharmaceutical& Chemicals in Tuesday's pre-opening session is sizzling on the bourses, and the stock is up by 20% at Rs 278.70, as
U.S. regulators have approved the first powerful, injected medicine to treat serious cases of the skin condition eczema. The Food and Drug Administration on Tuesday approved Dupixent for moderate or severe eczema, which causes red, fiercely itchy rashes on the face, arms and legs. Dupixent will have an initial list price of $37,000 per year, acc
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. The U.S. Food and Drug Administration today approved Dupixent injection to treat adults with moderate-to-severe eczema. "FDA's approval of Dupixent demonstrates our commitment to approving new and innovative therapies for patients wit
Pfizer and Merck KGaAs PD-L1 inhibitor, Bavencio, has become the first immunotherapy to be approved by the US Food and Drug Administration to treat a rare form of skin cancer, known as metastatic Merkel cell carcinoma. At the heart of this FDA approval is our drive to make a meaningful difference for patients with hard-to-treat cancers like metasta
Life science investors are familiar with the arduous path new drugs take to market. As 2016 proved, these therapeutic products can be equally hazardous to patient health and that s something the FDA takes seriously. Below, we examine how the FDA classifies, regulates and approves medical devices.
TESARO Inc' s niraparib has received FDA approval, ahead of its Prescription Drug User Fee Act date of June 30. Wedbush's David M. Nierengarten reiterated an Outperform rating on the company, while raising the price target from $164 to $174. Along with the FDA approval, there also are no genetic restriction on the niraparib label, which contains cl
Rockwell Medical announced it received clearance from theState Intellectual Property Office of the People s Republic of China for two patents related to its Triferic drug. We view China as a key strategic dialysis market that we anticipate may become the world s largest over the next several years.. About Triferic Triferic is the only FDA
Release date- 27032017- AstraZeneca today announced that the China Food and Drug Administration has granted marketing authorisation for Tagrisso 40 mg and 80 mg once-daily oral tablets for the treatment of adult patients with locally-advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer whose...
TESARO Inc announced the FDA approval of Zejula in recurrent ovarian cancer maintenance with a broad label. While reiterating a Neutral rating and a price target of $165 for Tesarao, Ulz mentioned that the market was highly competitive. Two competing PARP inhibitors had already been approved, AstraZeneca plc' s Lynparza and Clovis Oncology Inc' s R
The U.S. Department of Health and Human Services' Food and Drug Administration issued the following news release:. "Maintenance therapy is an important part of a cancer treatment regimen for patients who have responded positively to a primary treatment," said Richard Pazdur, M.D., acting director of the Office of Hematology and Oncology Products i
Release date- 23032017- OSAKA, Japan, FLORHAM PARK, N.J. and STAMFORD, Conn.- Shionogi Inc. and Purdue Pharma L.P. announced today that the U.S. Food and Drug Administration approved Symproic 0.2 mg tablets C-II as a once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation in adul
Release date- 24032017- Darmstadt, Germany, and New York, US- Merck and Pfizer Inc. today announced that the US Food and Drug Administration has approved BAVENCIO Injection 20 mg/mL, for intravenous use, for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma. Continued approval for this indicatio
iCAD, an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, today announced that PowerLook Tomo Detection received Premarket Approval from the U.S. Food and Drug Administration. "As the use of 3 D mammography continues to grow in the U.S. and abr
Novartis Kisqali ribociclib, LEE011 receives FDA approval as first-line treatment for HR+/ HER2- metastatic breast cancer in combination with any aromatase inhibitor. By a News Reporter-Staff News Editor at Clinical Trials Week- The US Food and Drug Administration has approved Kisqali in combination with an aromatase inhibitor as initial...
TESARO, Inc., an oncology-focused biopharmaceutical company, today announced that the U.S. Food and Drug Administration has approved ZEJULA?, an oral, once-daily poly polymerase inhibitor, for the maintenance treatment of women with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial respo
It received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from US Food and Drug Administration to market a generic version of Novartis Pharmaceuticals` TOBI 300 mg/5 ml. Lupin has the fifth largest pipeline of ANDA filings pending approval with US FDA 134 product filings pending approval. Cumulative Filings with the US FD
This week, "The US Food and Drug Administration has added one more clause in its import alert given to the drug maker, Divi's Laboratories Limited." Pharma Major Lupin Limited announced today that it has received final approval for its Tobramycin Inhalation Solution USP, 300 mg/5 ml from the United States Food and Drug Administration to market a ge
Release date- 23032017- Basel- Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration for its AcrySof IQ ReSTOR +2.5 Multifocal Toric intraocular lens with ACTIVEFOCUS optical design for patients undergoing cataract surgery who choose to address their astigmatism and presbyopi
-The unique optical design of the ACTIVEFOCUS (TM) toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vision to potentially reduce dependence on glasses. Basel, March 23, 2017- Alcon, the global leader in eye care and a division of Novartis, has received approval from the US Food and Drug Administration f