FREIENBACH, Switzerland–04.11.2021 EffRx Pharmaceuticals SA, a commercial-stage company that commercializes niche and orphan medicines in Switzerland and Europe, today announced that Swissmedic has approved Bronchitol® (inhaled mannitol) for the treatment of cystic fibrosis (CF) in adults and in children aged 6 years and above as add‐on to other medicines. The clinical…
KENILWORTH, N.J. & MIAMI--November 4, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has granted authorization in the United Kingdom (U.K.) for molnupiravir (MK-4482, EIDD-2801), the first oral antiviral…
28th October 2021 The European Medicines Agency (EMA) has approved Bioprojet’s Ozawade (pitolisant) for the treatment of excessive daytime sleepiness (EDS) associated with obstructive sleep apnoea (OSA) in adults. Ozawade was evaluated in two Phase III clinical studies in the treatment of EDS in patients suffering from OSA – HAROSA…
MISSISSAUGA, ON, Oct. 29, 2021 Libtayo® (cemiplimab) is now approved in Canada for the treatment of adults with locally advanced basal cell carcinoma (BCC) previously treated with a hedgehog pathway inhibitor (HHI).The approval of Libtayo follows the European Commission (EC) approval announced in June 2021 and the US in February 2021. With today's announcement, Libtayo is now offered as…
NORTH CHICAGO, USA., Oct. 29, 2021 Allergan, an AbbVie (NYSE: ABBV) company, announced the U.S. Food and Drug Administration (FDA) approval of VUITY™ (pilocarpine HCl ophthalmic solution) 1.25% for the treatment of presbyopia, commonly known as age-related blurry near vision, in adults. VUITY is the first and only FDA-approved eye drop to treat this…
Basel, October 29, 2021 Novartis announced today that the US Food and Drug Administration (FDA) approved Scemblix® (asciminib) for the treatment of chronic myeloid leukemia (CML) in two distinct indications. The FDA granted Scemblix accelerated approval for adult patients with Philadelphia chromosome-positive CML in chronic phase (Ph+ CML-CP) previously treated with…
KENILWORTH, N.J.--October 22, 2021 Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced that the European Commission (EC) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults whose tumors…
London, United Kingdom, Tuesday 26 October 2021 Gedeon Richter UK Ltd. (“Gedeon Richter”) today announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted a licence for Ryeqo (relugolix 40 mg, estradiol 1 mg, and norethisterone acetate 0.5 mg – herein “relugolix combination therapy”), for the treatment of…
October 26, 2021 Glenmark Pharmaceuticals Limited (Glenmark), a research-led global pharmaceutical company has launched a fixed dose combination (FDC) of its novel, patent protected, globally researched Sodium Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, with Metformin (first-line medication…
LAVAL, QC and ALPHARETTA, Ga., Oct. 25, 2021 Bausch + Lomb, a leading global eye health business of Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health"), and Clearside Biomedical, Inc. (Nasdaq: CLSD) ("Clearside"), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today announced that…