Following discussions with the US Food and Drug Administration (FDA), the company has finalized its clinical protocol and intends to begin patient enrollment within the next month at
Galderma gets FDA nod to market Restylane Lyft with lidocaine for age related volume loss in cheek area. Previously marketed as Perlane-L, Restylane Lyft is an injectable gel
Last year, the Russian pharmaceutical market recorded RUB765bn ($13.6bn) in sales, according to IMS Health. Biocom mainly focuses on therapies such as cardiovascular, central nervous system (CNS) and
Orkambi is only indicated for these patients, who can be identified with a genetic test. The company said that Orkambi will be available for shipment to specialty pharmacies
Approved under the trade name Sovaldi in March, Harvoni is a combination of the NS5A inhibitor ledipasvir and the nucleotide analog polymerase inhibitor sofosbuvir. The drug is indicated
Recently, the US Food and Drug Administration (FDA) has granted orphan drug designation for ARC-AAT to treat AATD. Currently, the company is enrolling patients at a single center
The IND acceptance will allow the company to begin an open label Phase I/II trial designed to evaluate its wholly-owned MAGE-A10 T therapeutic candidate in NSCLC. Currently, the
For the NDA, the FDA has provided an anticipated Prescription Drug User Fee Act (PDUFA) action date in February 2016. The NDA of Xeljanz 11mg is based on
Spiolto Respimat is now approved in Croatia, the UK, Slovakia, Denmark, Norway, Ireland, Austria, Romania and Spain. The company said that Spiolto Respimat provides significant improvements in lung
RHB-104 is an antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. Currently, RHB-104 is undergoing a first Phase III study for Crohn’s
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