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Astrazeneca
NEWS

AstraZeneca Reports P-III OBERON and TITANIA Results for Tozorakimab in COPD at ERS’26

Shots: AstraZeneca reported full results from the P-III OBERON and TITANIA studies, showing that tozorakimab 300 mg Q4W reduced moderate-to-severe COPD exacerbations versus PBO in pts. receiving inhaled standard of care In the primary population of former smokers, tozorakimab reduced exacerbations by 29% in OBERON and 34% in TITANIA, while reductions in the overall population…
September 8, 2026

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NEWS

Definium Therapeutics Receives FDA Breakthrough Therapy Designation (BTD) for DT120 in MDD

Shots: Definium Therapeutics announced that the US FDA granted BTD to DT120 (lysergide) orally disintegrating tablet (ODT) for the treatment of major depressive disorder (MDD), following positive P-III results In the P-III Emerge study, a single 100 µg dose of DT120 ODT demonstrated an 8.1-point PBO-adjusted improvement in MADRS total score at wk. 6 (p<0.0001),…
September 8, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in July 2026    

Shots:  The European Commission (EC) approved multiple new medicines in July 2026 across rare diseases, respiratory disorders, aesthetics, and oncology, involving companies including Novartis, Boehringer Ingelheim, AbbVie’s Allergan Aesthetics, and AstraZeneca.  EC approvals included Itvisma (onasemnogene abeparvovec) for patients aged ≥2 years with 5q spinal muscular atrophy (SMA) and confirmed bi-allelic SMN1 mutations; Jascayd (nerandomilast) for adults with idiopathic pulmonary…
August 18, 2026

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Pfizer New
NEWS

Pfizer Reports Positive P-III Results for LITFULO in Nonsegmental Vitiligo (NSV)

Shots: Pfizer reported positive topline results from the pivotal P-III TRANQUILLO and TRANQUILLO 2 studies evaluating LITFULO (ritlecitinib) in pts. with NSV. Both studies (n=2,174 pts) met their co-primary endpoints, demonstrating statistically significant improvements in facial and total body repigmentation vs. PBO at 52 wks. across 271 sites globally TRANQUILLO (n=607, ≥12yrs.) evaluated 50mg LITFULO and TRANQUILLO…
July 31, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in June 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in June 2026 across oncology, neurology, rare diseases, metabolic disorders, and infectious diseases, involving companies including Amgen, Immedica, Sanofi, Arrowhead Pharmaceuticals, Acadia Pharmaceuticals, and Zambon.  European Commission approvals included Imdylltra for extensive-stage small cell lung cancer (ES-SCLC), Zepzelca + Tecentriq as a first-line maintenance therapy for ES-SCLC, Cenrifki for secondary progressive…
July 21, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…
June 23, 2026

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NEWS

MoonLake Reports Positive Week 52 P-III (VELA) Data for Sonelokimab in Hidradenitis Suppurativa (HS)

Shots: MoonLake Immunotherapeutics reported positive 52 Wks. (n=396) results from the P-III (VELA-1) and (VELA-2) studies, demonstrating durable efficacy of sonelokimab in adults with moderate-to-severe HS At Week 52, 67.2% of pts. achieved HiSCR75, 33.1% achieved HiSCR100, and 26.0% reached inflammatory remission (IHS4-100). Sonelokimab also showed substantial improvements in quality of life and pain reduction,…
June 22, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in April 2026    

Shots:  The European Medicines Agency advanced multiple approvals and late-stage recommendations in April 2026 across infectious diseases, neurology, immunology, endocrinology, and rare disorders, involving companies including Merck, Moderna, Novartis, Sanofi, and Mitsubishi Tanabe Pharma  CHMP positive opinions included Redemplo for familial chylomicronemia syndrome, Itvisma for spinal muscular atrophy, and Cenrifki for non-relapsing SPMS  The EC also approved therapies including Enflonsia for RSV prevention in infants, mCOMBRIAX for influenza/COVID-19 prevention, Palsonify for acromegaly, Rhapsido for…
May 19, 2026

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INSIGHTS+

EMA Marketing Authorization of New Drugs in March 2026    

Shots:  The European Medicines Agency advanced multiple new drug approvals and late-stage recommendations in March 2026, spanning oncology, immunology, rare diseases, and women’s health, with key decisions involving Pharming, Immedica, Amgen, Gedeon Richter, UCB, and Sanofi  The Committee for Medicinal Products for Human Use issued positive opinions for innovative therapies, including leniolisib (Joenja) for APDS, lurbinectedin + atezolizumab…
April 21, 2026

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