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Lundbeck presents positive Phase IIb data for bocunebart (Lu AG09222; anti-PACAP mAb) in migraine prevention at the AHS congress

The intravenous part of the Phase IIb clinical dose-finding trial PROCEED met its primary endpoint, with bocunebart demonstrating a statistically significant reduction in monthly...

Emergent BioSolutions Supports Victoria’s Voice Foundation’s National Naloxone Awareness Day to Help Save Lives from Opioid Overdose

Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources 
Efforts focus on increasing awareness, expanding access to lifesaving NARCAN® Nasal Spray and reaching more communities with educational initiatives and resources

Johnson & Johnson late-breaking results show nipocalimab significantly reduced systemic lupus erythematosus (SLE) disease activity in a Phase 2 study

Nipocalimab – the first and only neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus – is designed to target and...

AbbVie Announces European Commission Approval of AQUIPTA® (atogepant) for the Acute Treatment of Migraine in Adults

AQUIPTA® (atogepant) is now approved in the European Union for the acute treatment of migraine in adults, with or without aura, and for the...

Valneva’s Chikungunya Vaccine IXCHIQ® Now Authorized in Canada for Individuals Aged 12 and Older

Saint Herblain (France), August 18, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that Health Canada has granted marketing authorization for its single-dose vaccine, IXCHIQ®, for the prevention of disease caused by the chikungunya virus in individuals aged 12 years and older. This announcement adds to the adult marketing authorization already received in Canada1 and complements the adolescent label extension received in Europe in April 20252.

Emmaus Life Sciences Reports Quarterly Financial Results

TORRANCE, Calif., Aug. 14, 2025 /PRNewswire/ -- Emmaus Life Sciences, Inc. (OTCQB: EMMA), a commercial-stage biopharmaceutical company and leader in the treatment of sickle cell...

FDA Approves BRINSUPRI™ (brensocatib) as the First and Only Treatment for Non-Cystic Fibrosis Bronchiectasis, a Serious, Chronic Lung Disease

— Approximately 500,000 U.S. Patients Are Diagnosed with Non-Cystic Fibrosis Bronchiectasis (NCFB), a Progressive Disease That Can Lead to Permanent Lung Damage — — BRINSUPRI 10...

Public Advisory – Fake (counterfeit) Cialis and Viagra seized from Toronto, Pickering, and Brantford stores may pose serious health risks

OTTAWA, ON, Aug. 8, 2025 /CNW/ - ...

Palisade Bio Reports 100% Clinical Response in Phase 1b Ulcerative Colitis Cohort with Novel PDE4 Inhibitor, PALI-2108

PALI-2108 demonstrated to be safe and well tolerated with no serious adverse events (SAEs)

Valneva Announces Removal of FDA-Recommended Pause on Use of Chikungunya Vaccine IXCHIQ® in Elderly and Updates to the Prescribing Information

Saint Herblain (France), August 7, 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the FDA has removed its recommended pause in the use of IXCHIQ® in individuals 60 years of age and older and has approved updates to the Prescribing Information (PI) for IXCHIQ®. IXCHIQ® remains indicated in the United States for the prevention of disease caused by the Chikungunya Virus (CHIKV) in individuals 18 years of age and older who are at high risk of exposure to CHIKV.

Jazz Pharmaceuticals Announces U.S. FDA Approval of Modeyso™ (dordaviprone) as the First and Only Treatment for Recurrent H3 K27M-mutant Diffuse Midline Glioma

Modeyso is the first treatment option for this ultra-rare and aggressive brain tumor, which primarily affects children and young adults Accelerated approval based on an...

PTC Therapeutics Announces FDA Approval of Sephience™ (sepiapterin) for the Treatment of Children and Adults Living with Phenylketonuria (PKU)

- Broad labeling inclusive of all disease subtypes for individuals 1 month of age and older - - PTC will host a conference call on...

Donanemab receives positive opinion from the Committee for Medicinal Products for Human Use (CHMP) in early symptomatic Alzheimer’s disease

The opinion will now be referred to the European Commission for final regulatory decision on donanemab  INDIANAPOLIS, July 25, 2025 /PRNewswire/ -- Eli Lilly and...

Pfizer and BioNTech Receive Positive CHMP Opinion for LP.8.1-Adapted COVID-19 Vaccine in the European Union

NEW YORK and MAINZ, GERMANY, July 25, 2025 — Pfizer Inc. (NYSE: PFE, “Pfizer”) and BioNTech SE (Nasdaq: BNTX, “BioNTech”) announced today that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization for the companies’ LP.8.1-adapted monovalent COVID-19 vaccine (COMIRNATY® LP.8.1) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the EMA’s Emergency Task Force (ETF) to update COVID-19 vaccines to target the LP.8.1 variant for the 2025-2026 season. The ETF stated that “targeting LP.8.1 will help maintain the effectiveness of the vaccines as SARS-CoV-2 continues to evolve.”2

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