The FDA has issued a long-awaited approval of Novavax’s COVID-19 vaccine but with unusual restrictions. Novavax makes the nation’s only traditional protein-based coronavirus vaccine – and until now… read more.
NICE (UK): Leniolisib is recommended, within its marketing authorisation, for treating activated phosphoinositide 3‑kinase delta syndrome (APDS) in people 12 years and over. Leniolisib is recommended only if the… read more.
Fresenius announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has issued a positive opinion for its denosumab biosimilar candidates, Bomyntra and Conexxence… read more.
Liquidia Corporation announced that the FDA has approved Yutrepia (treprostinil) inhalation powder, a prostacyclin analog for adults with pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial… read more.
Gilead Sciences, Inc., following the recent acquisition of CymaBay Therapeutics, Inc., announced two-year interim results from the ongoing ASSURE study of investigational seladelpar for the treatment of primary… read more.
ALK-Abello announced that its European regulatory filing for Itulazax (tree pollen sublingual allergy immunotherapy tablet) for treatment of young children and adolescents aged five to 17 has been… read more.
Positive full results from the BATURA Phase IIIb trial showed AstraZeneca’s anti-inflammatory reliever rescue therapy, Airsupra (albuterol/budesonide), demonstrated statistically significant and clinically meaningful improvements in all primary and… read more.
The FDA has approved an expanded indication of Sanofi’s quadrivalent meningococcal vaccine MenQuadfi—for the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W,… read more.
Bavarian Nordic A/S announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization in the United Kingdom (UK) for Vimkunya (recombinant, adsorbed) for… read more.
Medtronic plc announced positive clinical outcomes from two studies in atrial fibrillation (AFib) patients treated with the Affera family of technologies, including the next-generation Sphere-360 single-shot pulsed field… read more.
Results from a post-hoc exploratory subgroup analysis from the NIAGARA Phase III trial showed AstraZeneca’s Imfinzi (durvalumab), administered perioperatively in combination with neoadjuvant chemotherapy, demonstrated improvements in event-free… read more.
Hympavzi (marstacimab) from Pfizer has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) to treat haemophilia A or B in adult and paediatric patients…. read more.
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