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European approval for Teva’s migraine drug Ajovy pharmatimes
April 02, 2019
Teva has received European Commission approval for its migraine drug, Ajovy (fremanezumab). The drug is a pre-filled syringe for the prophylaxis of migraine in adults who have at least four migraine days per month.
FDA approves treatment for patients with a type of inflammatory arthritis worldpharmanews
March 29, 2019
This is the first time that the FDA has approved a treatment for nr-axSpA.
Alembic Pharma gets USFDA nod for erectile dysfunction drug expressbpd
March 28, 2019
The approval from the USFDA, is for the company’s abbreviated new drug application (ANDA) for Tadalafil tablets USP, in the strengths of 2.5 mg, 5mg, 10mg and 20 mg.
Vertex receives approval for CF drug in Australia biospectrumasia
March 20, 2019
Tezacaftor/ivacaftor in combination with ivacaftor was approved by the U.S. Food and Drug Administration (FDA) in February 2018, by Health Canada in June 2018 and by the European Commission in October 2018.
Chugai’s Hemlibra receives approval for severe Hemophilia A biospectrumasia
March 15, 2019
Hemlibra is now available for hemophilia A without inhibitors in the EU, following US and Japan
Regeneron/Sanofi wins US approval for expanded use of skin drug expressbpd
March 14, 2019
The US Food and Drug Administration said it approved expanded use of Regeneron Pharmaceuticals Inc and Sanofi SA’s eczema drug Dupixent to include patients aged between 12 and 17
Roche’s Tecentriq notches win in breast cancer with US approval expressbpd
March 14, 2019
The FDA’s OK was based on a trial that showed the drug cocktail helped stave off the disease’s advance by a median 7.4 months, compared to 4.8 months with chemotherapy
FDA approves new nasal spray medication for treatment-resistant depression; available only at a certified doctor's office or clinic worldpharmanews
March 07, 2019
The U.S. Food and Drug Administration (FDA) today approved Spravato (esketamine) nasal spray
Glenmark receives ANDA approval for Clobetasol Propionate Foam biospectrumasia
February 19, 2019
It is a generic version of Olux®1 Foam, 0.05%, of Mylan Pharmaceuticals
Glenmark receives ANDA approval for sevelamer hydrochloride tablets expressbpd
February 12, 2019
Sevelamer is indicated to patients with severe kidney disease to lower high blood phosphorus levels

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