All News

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

Pfizer-BioNTech announced plans to seek FDA approval this month of a smaller dose of its Comirnaty vaccine for children ages 5–11.

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.

Health Canada approved the new drug submission for Spikevax—more commonly known as the Moderna COVID-19 vaccine—for active immunization to prevent COVID-19 in individuals 12 years of age and older.

FDA revised the emergency use authorization for bamlanivimab and etesevimab (administered together) to include emergency use as post-exposure prophylaxis (prevention) for COVID-19.

Moderna’s newest insights include an overall efficacy review, a study on breakthrough infections, and a study on long-term immunity.

Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.

The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.

Takeda’s Exkivity (mobocertinib) was approved by FDA for the treatment of patients with lung cancer.

CPC’s MicroCNX Series Connectors provide an alternative to tube welding at small tubing sizes.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

AzurRx’s acquisition of First Wave Bio grants them access to their proprietary niclosamide formulations.

The joint venture with OSTHUS will expand PharmaLex’s IT consulting and system integration expertise.

InMed Pharmaceuticals looks to expand their cannabinoid pipeline with the acquisition of BayMedica.

Repligen and Navigo’s novel ligand could be the first to address antibody aggregation in low pH elution buffers.

AGC Biologics is expanding manufacturing capacity at its Heidelberg, Germany, facility for plasmid DNA and messenger RNA.

HUTCHMED’s amdizalisib (HMPL-689) received breakthrough therapy designation for the treatment of a subtype of non-Hodgkin’s lymphoma.

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

Boehringer Ingelheim and Twist Bioscience will use Twist’s antibody libraries to discover therapeutic antibody candidates.

Janssen’s Invega Hayfera is the first six-month injectable schizophrenia treatment approved by FDA.

Vector Laboratories has completed a $124 million cash buyout backed by Thompson Street Capital Partners and will begin an acquisition strategy to expand protein detection capabilities.

Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

The orphan drug designation for TCR² Therapeutics’ Gavo-cel will facilitate research into a treatment for cholangiocarcinoma.

Moderna’s new single-dose vaccine will be a booster for both COVID-19 and the flu.

Moderna announced a collaboration to develop a new mRNA therapeutic for Crigler-Najjar Syndrome Type 1 at no cost to patients.

AstraZeneca and the European Commission have reached an agreement that ends legal proceedings over the execution of the advance purchase agreement for the delivery of Vaxzevria.

The Coalition for Epidemic Preparedness Innovations stated that developing the next generation of COVID-19 vaccines will only be possible if comparator vaccines are available for clinical trials.

FDA placed a clinical hold on the BMN 307 Phearless Phase I/II study, which was evaluating an investigational PAH gene therapy in adults with PKU.