Regulatory Authority Actions

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

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

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

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

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.

Impel Neuropharma’s Trudhesa, a nasal spray, received FDA approval for treating migraines in adults with and without aura.

FDA clearance of trans sodium crocetinate allows Diffusion to proceed with their latest Phase II oxygenation trial.

Proposed changes to rules governing the commercialization of technologies developed with federal funding prompts significant stakeholder feedback.

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

The European Commission has granted marketing authorization to Incyte and MorphoSys for Minjuvi (tafasitamab) in combination therapy with lenalidomide to treat relapsed or refractory DLBCL.

Will FDA’s approval of Semglee create a surge in the development of interchangeable biosimilars?

FDA formally unveiled its plan for revising and renewing its fee program for drugs and biologics.

FDA has cleared QSAM Biosciences’s IND application for Samarium-153 DOTMP (CycloSam).

Japan has suspended the use of more than 1.63 million potentially contaminated doses of the Moderna vaccine.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

FDA’s draft guidance provides recommendations for how to include bioequivalence information in ANDAs and ANDA supplements.

HHS Public Health and a team of medical experts recommend that COVID-19 vaccine booster shots will soon be necessary.

FDA approved the Pfizer-BioNTech COVID-19 vaccine, which will be marketed as Comirnaty.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

FDA granted orphan drug designation to Paratek Pharmaceuticals for NUZYRA (omadacycline), an investigational antibiotic.

Lilly’s insulin, lyumjev, receives FDA approval for an expanded label.

FDA has granted its first approval for an idiopathic hypersomnia treatment.