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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…
Basel, 22 October 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that the U.S. Food and Drug Administration (FDA) has approved Susvimo™ (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with neovascular or “wet” age-related macular degeneration (nAMD) who have previously responded to…
PRINCETON, N.J. (10/21/2021) Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved Opdivo (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express…
CAMBRIDGE, Mass. & BEIJING & MOSCOW October 20, 2021 The Russia Ministry of Health has approved BeiGene’s Brukinsa (zanubrutinib) to treat patients with relapsed or refractory mantle cell lymphoma (MCL). Marketing approval for BRUKINSA for the treatment of MCL in Russia is based on results from two single-arm clinical trials.…
USA，CAMBRIDGE, Mass October 20, 2021 Luminopia, a digital therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted de novo premarket approval for Luminopia One as a prescription therapy to improve vision in children with amblyopia (lazy eye), the leading cause of vision loss in children.…
October 20, 2021 Today, the U.S. Food and Drug Administration took action to expand the use of a booster dose for COVID-19 vaccines in eligible populations. The agency is amending the emergency use authorizations (EUA) for COVID-19 vaccines to allow for the use of a single booster dose as follows:…
MIAMI, Oct. 19, 2021 Intrivo announced today the launch of On/Go™, an at-home rapid COVID-19 antigen self-test that delivers results with 95% accuracy in just 10 minutes. On/Go, which has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), is an affordable and easy-to-use self-test with a…
PRINCETON, N.J., October 18, 2021 Oyster Point Pharma, Inc. (Nasdaq: OYST), announced that the U.S. Food and Drug Administration (FDA) has approved TYRVAYA™ (varenicline solution) Nasal Spray 0.03 mg for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray is the first and only nasal spray…
FOSTER CITY, Calif October 18, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) announced the U.S. Food and Drug Administration (FDA) approved a new low-dose tablet dosage form of Biktarvy® (bictegravir 30 mg/emtricitabine 120 mg/tenofovir alafenamide 15 mg tablets) for pediatric patients weighing at least 14 kg to less than 25 kg who…
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