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Zydus Cadila gets US FDA nod for knee osteoarthritis drug expressbpd
April 20, 2018
The drug will be produced at the group’s topical manufacturing facility at Ahmedabad.
Eli Lilly and Incyte Shares Drop as FDA Raises Concerns about Arthritis Drug biospace
April 20, 2018
Ahead of next Monday’s U.S. Food and Drug Administration (FDA)committee review of Eli Lilly and Incyte’s baricitinib for rheumatoid arthritis, concerns over blood clots, may scuttle the drug’s chances.
OBI Pharma gets FDA clearance for new drug application biospectrumasia
April 20, 2018
OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3)
US gives nod to Glenmark for skin ointment expressbpd
April 19, 2018
Glenmark Pharmaceuticals has received final approval from the US health regulator for Tacrolimus ointment used for treating atopic dermatitis (eczema).
Lupin gets US FDA nod to market testosterone gel expressbpd
April 19, 2018
Lupin has received tentative nod from the US health regulator to market its Testosterone gel 1.62 per cent.
FDA Approves First Therapy for Rare Inherited Form of Rickets, X-Linked Hypophosphatemia americanpharmaceuticalreview
April 19, 2018
FDA approved Crysvita (burosumab), the first drug approved to treat adults and children ages 1 year and older with x-linked hypophosphatemia (XLH), a rare, inherited form of rickets.
NeuroVive's KL1333 Receives FDA Orphan Drug Designation for Treatment of Mitochondrial Diseases biospace
April 19, 2018
NeuroVive Pharmaceutical AB today announced that it has been granted Orphan Drug Designation by the United States FDA Office of Orphan Products Development for its project KL1333 for treatment of inherited mitochondrial respiratory chain diseases (MRCD)
FDA Commissioner Goes to Bat for the BioPharma Industry biospace
April 19, 2018
During a meeting with FDA Commissioner Scott Gottlieb earlier this week, government and healthcare officials in New Jersey highlighted the need to hasten the approval of new drugs and permanently eliminate the tax on medical devices.
FDA flip-flops on Alkermes' drug application pharmafile
April 18, 2018
Two weeks ago, it looked like the hopes for Alkermes’ ALKS 5461 receiving approval would rely on returning to the clinic to undergo the lengthy process of gathering more data on the drug, after it received a Refuse to File letter from the FDA.
Roche haemophilia drug gets fast FDA review in expanded use pharmaphorum
April 18, 2018
The FDA has granted ‘Breakthrough Therapy’ status for Roche’s Hemlibra (emicizumab) for people with haemophilia A without factor VIII inhibitors, as the Swiss firm aims to take market share from rivals including Shire.

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