Food and Drug Administration (FDA)

Ipsen have announced the approval by the U.S. FDA of Sohonos capsules as a retinoid indicated for the reduction in volume of new heterotopic ossification in individuals with fibrodysplasia ossificans progressiva.

Calliditas Therapeutics AB have announced that the U.S. Food and Drug Administration (FDA) has accepted the submission for the supplemental New Drug Application (sNDA) for TARPEYO delayed release capsules and granted Priority Review.

Regeneron Pharmaceuticals, Inc. announced the FDA has approved Veopoz (pozelimab-bbfg) for the treatment of adult and pediatric patients 1 year of age and older with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.

Pfizer Inc has announced that the U.S. Food and Drug Administration has approved ABRYSVO (Respiratory Syncytial Virus Vaccine), the company’s bivalent RSV prefusion F (RSVpreF) vaccine.

Regeneron Pharmaceuticals recently announced that the U.S. Food and Drug Administration (FDA) has approved EYLEA HD (aflibercept) Injection 8 mg.

Medtronic have presented the outcome of the FDA Circulatory System Devices Panel (CSDP) meeting to review data presented in support of the Medtronic Symplicity Spyral Renal Denervation (RDN) System.

Johnson & Johnson have announced that the European Commission has granted conditional marketing authorisation of TALVEY (talquetamab) as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma.

LEO Pharma has announced that it signed an agreement to acquire U.S.-listed Timber Pharmaceuticals, Inc. Upon closing, this transaction will add an attractive late-stage asset to LEO Pharma’s pipeline in medical dermatology.

Gain Therapeutics have announced preclinical data demonstrating the Company’s lead drug candidate GT-02287 significantly decreased Parkinson’s disease (PD)-associated pathology and improved motor dysfunction in two different preclinical models of PD.

Regulatory authorities have been focusing on safeguarding global supply chains. Juan Torrijos Lopez, GMP consultant at Rephine provides some practical pointers as to how pharmaceutical manufacturers should respond to evolving expectations.

Dr. Samir Acharya, Dr. Rajiv Vaidya and Cyrill Kellerhals from Andelyn Biosciences discuss the trends in the field of C&GT and explore the current and future challenges facing C&GT developers and manufacturers as well as solutions to overcome.

Idorsia Ltd recently announced that it has entered into an agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the return of rights for aprocitentan to Idorsia.

Natural Cycles, the company that developed the world’s first birth control app, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its use of wrist temperature data from Apple Watch.

Martin Gadsby, VP at Optimal Industrial Technologies, looks at how to automate analytical laboratories to improve pharmaceutical operations.

Calliditas Therapeutics AB have announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Alport syndrome with setanaxib.

FluoGuide A/S announces its lead asset FG001 has received Orphan Drug Designation from the U. S. Food and Drug Administration (FDA) as an optical imaging agent for the visualisation of malignant tissue during surgery for high-grade glioma.

Phillips-Medisize has teamed with GlucoModicum to design and eventually commercialise a proprietary non-invasive, wearable device that removes technology and patient-care roadblocks to continuous glucose monitoring.

Novavax, Inc recently announced that the Novavax COVID-19 Vaccine has received Emergency Use Authorisation from the U.S. FDA for active immunisation to prevent COVID-19 in individuals aged 12 and older.

Quotient Sciences announces the successful completion of a US Food and Drug Administration (FDA) inspection of its bioanalytical facility in Alnwick, UK.

Carthera announces the signing of a strategic collaboration with Accord Healthcare Limited, a leading pharmaceutical company, for the supply of carboplatin. The financial terms of the agreement have not been disclosed.

The European Commission’s revision of its Good Manufacturing Practices (GMP) Annex 1 for sterile drug products will have implications for pharmaceutical companies that market their sterile drug products in the EU.

AbbVie have provided updates from the FDA and EMA for epcoritamab, an investigational T-cell engaging bispecific antibody administered subcutaneously, for relapsed or refractory (R/R) follicular lymphoma (FL).

Agepha Pharma together with Caristo Diagnostics have announced their collaboration to improve awareness and clinical education about the central role of inflammation in coronary artery disease.

Novo Nordisk have announced that the US FDA has approved a label expansion for Wegovy for the indication of reducing risks of major adverse cardiovascular events.

Madrigal Pharmaceuticals have announced that the U.S. FDA has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH.

Orchard Therapeutics, recently acquired by Kyowa Kirin, have announced the U.S. FDA has approved Lenmeldy for the treatment of children with early-onset—metachromatic leukodystrophy.

SK Life Science, a subsidiary of SK Biopharmaceuticals, have announced that the U.S. Food and Drug Administration approved two new administration options of XCOPRI (cenobamate tablets) CV, an antiseizure medication.

GSK have announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY (MenABCWY) vaccine candidate.

Takeda have announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO (vedolizumab) subcutaneous administration for maintenance therapy in adults with moderately to severely active Crohn’s disease.

Alvotech announced a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration approved high-concentration interchangeable biosimilar to Humira.

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