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 The leading web portal for pharmacy resources, news, education and careers November 21, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - November 21, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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Articles(s): 1 - 25 of 102     Next >>     Go To Page:

11/21/17 - Biocon shares rise 7% after Bengaluru unit gets US FDA clearance [Arab Times (Kuwait)]
Biocon Ltds shares jumped over 7% after the company said on Monday that its manufacturing facility in Bengaluru, which had received observations relating to lapses in quality compliance earlier this year, has been cleared by the US Food and Drug Administration. The US FDA has issued an Establishment Inspection Report in relation to the cGMP inspect
11/21/17 - Chugai's HEMLIBRA Receives the World's First Regulatory Approval from FDA for Hemophilia A with Inhibitors
The US Biologics License Application was submitted by Genentech, a member of Roche Group. 'We are pleased that HEMLIBRA, a biopharmaceutical created by Chugai scientists based on their exceptional idea, has received its first regulatory approval,' said Chugai's President& COO, Tatsuro Kosaka.' HEMLIBRA is a first in class biopharmaceutical which is
11/21/17 - Cipla Receives Final Approval for Generic Pulmicort Respules
India, Mumbai- Cipla Ltd, a global pharmaceutical company, today announced that it has received final approval for its Abbreviated New Drug Application for Budesonide Inhalation Suspension, 0.25 mg/2mL, 0.5 mg/2mL, and 1 mg/2mL from the United States Food and Drug Administration to market a generic version of Astrazeneca's Pulmicort Respules.
11/21/17 - Emergent BioSolutions Receives FDA Approval to Manufacture ACAM2000 at Canton, Massachusetts Facility
Finalizing and receiving FDA licensure for the tech transfer of ACAM2000 manufacturing at the Canton facility is a significant step forward in support of the U.S. governments strategy of establishing domestic capabilities to manufacture an FDA- licensed smallpox vaccine, said Sean Kirk, senior vice president manufacturing operations and CMO busines
11/21/17 - FDA approval of genetic test for alpha-1 deficiency and EMA approval of fibrin sealant
Barcelona- Grifols has received approval by the U.S. Food and Drug Administration for a new genetic test to detect alpha-1 antitrypsin deficiency. A1AT Genotyping Test, developed by Progenika Biopharma, a Grifols subsidiary headquartered in Bilbao is capable of simultaneously analyzing 99% of the most prevalent known mutations causing alpha-1...
11/21/17 - FDA Approves Epinephrine Auto-injector for Small Children
The FDA has approved the Auvi-Q 0.1 mg the first and only epinephrine auto-injector (EAI) with a needle length and dose specifically designed for infants and small children.
11/21/17 - FDA Approves Fasenra for Severe Asthma Stemming from Immune Cell Glut [Syrian Arab News Agency]
The U.S. Food and Drug Administration has approved Fasenra as an add-on maintenance treatment for people 12 years and older with severe asthma. In this case, the authorization is for asthma stemming from an over-abundance of immune cells known as eosinophils. The companies that developed the therapy, AstraZeneca and MedImmune, evaluated its safety
11/21/17 - FDA approves first telehealth option to program cochlear implants remotely
The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especial
11/21/17 - FDA Approves Genentech's Alecensa Alectinib as First-Line Treatment for People With Specific Type of Lung Cancer
By a News Reporter-Staff News Editor at Cancer Weekly Genentech, a member of the Roche Group, announced that the U.S. Food and Drug Administration approved the supplemental New Drug Application for Alecensa for the treatment of people with anaplastic lymphoma kinase- positive metastatic non-small cell lung cancer as detected by an FDA- approve
11/21/17 - FDA Approves Genentech's Gazyva for Previously Untreated Advanced Follicular Lymphoma
South San Francisco, CA- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration approved Gazyva in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma. Gazyva's supplemental Biologics License Application based on
11/21/17 - FDA Approves Genentech's Hemlibra for Hemophilia A with Inhibitors
South San Francisco, CA- Genentech, a member of the Roche Group, announced today that the U.S. Food and Drug Administration has approved HEMLIBRA for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors. 'People with hemophilia A who develop inhibitors face
11/21/17 - FDA approves Hemlibra to prevent bleeding in patients with haemophilia A [Tehran Times (Iran)]
The US Food and Drug Administration has approved Hemlibra to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with haemophilia A, who have developed antibodies called Factor VIII inhibitors. Todays approval provides a new preventative treatment that has been shown to significantly reduce the number of bleeding...
11/21/17 - FDA approves remote programming feature for Nucleus Cochlear Implant System via telemedicine [T-break Tech (Middle East)]
The U.S. Food and Drug Administration today approved a remote feature for follow-up programming sessions for the Nucleus Cochlear Implant System through a telemedicine platform. Being able to have a qualified audiologist program the device via telemedicine from a remote location can greatly reduce the burden to patients and their families, especial
11/21/17 - FDA approves Roche's Gazyva for previously untreated advanced follicular lymphoma
Roche announced today that the US Food and Drug Administration approved Gazyva in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previously untreated advanced follicular lymphoma. 'Today's Gazyva approval is an important advance for the thousands of people diagnosed each year with follicular lymphoma
11/21/17 - FDA OKs new therapy for some hemophilia patients
The list price will be about $482,000 for the first year and slightly less after that, said California- based Genentech, which developed the drug. Genentech, the biotech subsidiary of Swiss drugmaker Roche, said that is half the cost of the only other preventive option for patients with this problem. The FDA gave expedited approval to Hemlibra, als
11/21/17 - Kalo auto-injector for infants approved Kaleo auto-injector for infants approved
Richmond-based pharmaceutical company Kalo has received federal approval to market an epinephrine auto-injector to treat life-threatening allergic reactions in babies as small as 16.5 pounds. The U.S. Food and Drug Administration on Friday tweeted approval for a new dosage of Kalo's Auvi-Q epinephrine device. Vivian Hernandez-Trujillo, a Miami-
11/21/17 - Medtronic Announces FDA Approval and U.S. Launch of Next Generation Pacemakers
Medtronic issued the following news release:. Medtronic plc today announced U.S. Food and Drug Administration approval and U.S. commercial launch for its portfolio of Azure (TM) pacemakers with BlueSync (TM) technology. Azure pacemakers feature Medtronic- exclusive BlueSync technology, which enables automatic, secure wireless remote monitoring via
11/21/17 - Roche - FDA approves Roche's Hemlibra for haemophilia A with inhibitors
Roche today announced that the US Food and Drug Administration has approved Hemlibra for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with haemophilia A with factor VIII inhibitors. 'People with haemophilia A who develop inhibitors face significant challenges preventing bleeds and typically...
11/21/17 - Teligent, Inc. Announces FDA Approval of Erythromycin Topical Solution USP, 2%
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced it has received approval of the Company s abbreviated new drug application from the U.S. Food and Drug Administration of Erythromycin Topical Solution USP, 2%. Erythromycin Topical Solution USP, 2% is Teligent s eighth FDA approval in 2017,?
11/20/17 - Batu Biologics Receives FDA Clearance for First Multi-Pronged Immunotherapy Targeting the Blood Vessels that Feed Cancer
By a News Reporter-Staff News Editor at Cancer Vaccine Week Batu Biologics, an immuno-oncology company dedicated to the development of its tumor-angiogenesis targeting immune therapy, ValloVax?, has received an Investigational New Drug approval from the U.S. Food and Drug Administration allowing Batu to proceed with Phase 1 clinical trials.
11/20/17 - Biocon rallies 4% after Bengaluru unit gets cleared by US FDA [India Infoline News Service]
The US FDA had audited the company s aseptic drug facility between May 25 and June 3 The US Food and Drug Administration issued an Establishment Inspection Report in relation to the inspection of Biocon s Bengaluru unit. The US FDA had previously issued a report in which they issued 10 observations on Biocon s Bengaluru plant. Biocon Ltd i
11/20/17 - Chugai's ALK Inhibitor "Alecensa" Approved for the Treatment of First Line Therapy on ALK-Positive Non-Small Cell Lung Cancer in the US
By a News Reporter-Staff News Editor at Pharma Business Week Chugai Pharmaceutical Co., Ltd. announced that Genentech Inc., a member of the Roche Group, obtained approval from the U.S. Food and Drug Administration, for Alecensa in the treatment of "anaplastic lymphoma kinase- positive metastatic non-small cell lung cancer". "In July 2014, Ale
11/20/17 - Cipla receives final approval for Generic Dacogen [India Infoline News Service]
Generic Dacogen vial is indicated for treatment of patients with myelodysplastic syndromes Cipla has announced that it has received final approval for its Abbreviated New Drug Application for Decitabine Injection 50 mg single-use sterile vial from the United States Food and Drug Administration to market a generic version of Otsuka America...
11/20/17 - Divi's Lab seen up as USFDA clears Vizag Unit-II [India Infoline News Service]
Shares of Divi's Laboratories is likely to gain in today's trade following the approval from the USFDA for its Vizag unit. Divi's Laboratories is likely to witness positive traction in the stock as the US Food and Drug Administration has cleared the company's unit-II in Vishakhapatnam, Andhra Pradesh. In the last trading session, Divis Laboratories
11/20/17 - Emergent BioSolutions Receives FDA Approval to Manufacture ACAM2000 at Canton, Massachusetts Facility
Emergent BioSolutions Inc. today announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for the manufacture of ACAM2000 , in the company s newly-acquired cGMP live viral manufacturing facility in Canton, Massachusetts. Finalizing and receiving FDA licensure for the tech transfer of
Articles(s): 1 - 25 of 102     Next >>     Go To Page:


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